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Lymphoma SPORE

Lymphoma SPORE
Stephen, J. Forman, M.D.
Principal Investigator

Andrew Raubitschek, M.D.
Co- Principal Investigator
 
The overall goal of the City of Hope Lymphoma Specialized Program of Research Excellence (SPORE) is to develop translational studies to improve the detection and therapy of Hodgkin’s and non-Hodgkin’s Lymphoma. This grant consists of four translational research projects and five cores developing novel approaches that are derived from molecular and immunologic studies of T-cell and antibody based therapies. An important theme of the translational studies in this grant is to develop lymphoma therapies that will reduce toxicities associated with current treatment regimens for Hodgkin’s and non-Hodgkin’s Lymphoma which can then be translated to the older patient population.
 
Main Research Projects
The major goal ofProject 1is to develop anti-CD30 based radioimmunotherapy for both Hodgkin’s and CD30+ non-Hodgkin’s Lymphoma.

Project 2will study the effectiveness of cellular immunotherapy to eradicate B-lineage lymphoma using genetically modified CD4+ and CD8+ T-cells expressing a CD19-specific chimeric immunoreceptor, which recognizes CD19 malignant B-cells.

Because epidemiologic studies indicate that stem cell damage from pretransplant therapeutic exposures may play a role in the development of myelodysplasia,Project 3will longitudinally study a population of patients with Hodgkin’s and non-Hodgkin’s Lymphoma to investigate the cellular and molecular factors that are predictive for development of myelodysplasia, and to determine the molecular sequence of events that lead to myelodysplasia.

InProject 4, investigators will develop molecularly engineered constructs for anti-CD20 directed therapeutics to improve imaging, radioimmunotherapy, and novel immunocytokines for the treatment of patients with CD20+ lymphoma. An important component of this project will be to delineate the immunologic effector mechanisms operative in immunocytokine-mediate anti-lymphoma in vivo activity.

This Lymphoma SPORE also supports aDevelopmental Research Programand aCareer Development Programto foster the advancement of pilot translational research projects and young investigators focused on lymphoma.

Animal Models and Assays Core

David Colcher, Ph.D.
Director

Core E is the Animal Models and Assay Core. This core has two main functions: a) to help evaluate the materials that are intended for clinical studies, in a number of model systems, using the advanced animal imaging instrumentation available at City of Hope ; and b) the analysis of clinical blood, urine, bone marrow, and tissue biopsy samples.

The Specific Functions are:

To provide the needed facilities and expertise for evaluating the biodistribution and imaging cells and antibody constructs in small animals, and

To perform core studies on clinical samples obtained from patients entered on imaging and therapy trials.

Core E is a critical component of Projects 1, 2 and 4. All antibody and T-cell constructs are evaluated in vitro and in vivo prior to translation into the clinic. The in vivo analysis are performed as part of this Core using the expertise of the Cores personnel. Animal biodistribution and imaging studies are performed using the Core personnel with help as needed from the individual projects. Luciferase transfected tumor cell lines and T-cells that are generated as part of the projects and antibodies and their engineered constructs are radiolabeled as part of the individual projects.

The in vivo studies are performed in City of Hopes Animal Resource Center in the Parvin building. City of Hopes National Medical Center and Beckman Research Institute has developed an animal imaging facility. It has two Xenogen in vivo biophotonic imaging system (IVIS), a Biospace Instruments animal gamma scintillation camera, a Concorde Microsystems microPETÆ R4 and a Siemens MicroCAT for small animals imaging.

This core also analyzes clinical samples from patients participating in the clinical trials included as part of Projects 1, 2 and 4. Analysis of blood and urine samples to determine the pharmacodynamics of the radiolabeled antibodies and their engineered constructs will be performed by this Core. Samples are counted to determine the pharmacokinetics and selected samples are analyzed by high performance liquid chromatography to evaluate the status of the labeled construct. In vitro assays to determine circulating levels of infused antibodies and constructs, as well as their immunogenicity, are also performed by this Core. Immunoassays will be performed by ELISA or using methods developed using the PerkinElmer VICTOR3 plate reader using time-resolved fluorometry.

Biostatistics and Data Management

Joyce C. Niland, Ph.D.
Director

The Biostatistics Core provides its statistical expertise across all SPORE research activities, including study design, safety monitoring, data collection, data quality assurance, and data analysis. The Biostatistics Core ensures that the proposed research hypotheses will be measured, tested, and interpreted, independent of whether the data will come from epidemiological studies, basic science, translational or immunologic studies, imaging, or clinical trials.

The centralized, comprehensive framework of the Biostatistics Core assures each SPORE investigator access to statistical expertise that includes collaborative development of study designs and analysis plans, data analysis and interpretation, data management resources, and abstract and manuscript preparation. The Biostatistics Core also provides infrastructure for the management and integration of both existing and newly collected data through consistent and compatible data handling. The Core has an integral role in the scientific development, execution, and analysis of all projects in the SPORE, including the clinical trials.
 
Core investigators have extensive experience in quantitative methods for biomedical applications, including clinical, basic, and translational science studies. The Core is committed to taking a leadership role in the scientific integrity of the SPORE investigations, to participating in regular project and program meetings, and to providing rigorous and innovative input on all quantitative matters arising in the projects. Their contribution to each project places them in a unique position to promote interdisciplinary interactions and innovative hypotheses for exploration.

Administrative Core

Stephen J. Forman, M.D.
Director

Eileen Smith, M.D.
Co-Director

The Administrative Core provides for the administration of the Lymphoma SPORE including administrative and budget support for all the SPORE investigators.

In addition, this Core provides communication with the National SPORE Program Staff, coordination with City of Hope ’s Comprehensive Cancer Center Administrative Office, preparation of progress reports, management of financial and reporting obligations, organization of the weekly research meetings of the basic science and clinical research staff, coordination of intra- and inter-institutional and inter-SPORE projects, as well as organizing the attendance and presentations at the annual City of Hope Lymphoma SPORE retreat, the annual SPORE meeting, and SPORE workshops at the National Cancer Institute.

Importantly, this core is responsible for the oversight of the Developmental Research and Career Development Programs in the City of Hope Lymphoma SPORE. Publications, grant submissions and INDs are also coordinated and supported through this Core.

In addition, the Administrative Core arranges the Executive and Steering Committee meetings that reviews the progress of the work and organize the annual External Advisory Board meetings.

 

 

Biological Materials Production Core

David DiGiusto Ph.D.
Director

David Colcher, Ph.D.
Director

Core D is the biologic materials production (manufacturing) core. Core D activities, the production of plasmid DNA, ex-vivo genetic modification and expansion of T-cell products and production and conjugation of monoclonal antibodies (Projects 1, 2 and 4), performed in The Center for Biomedicine and Genetics (CBG) on the campus of City of Hope s National Medical Center.

The CBG is a fully licensed biologics manufacturing facility operated under the principles of current Good Manufacturing Practices (cGMP) and Good Tissue Practices (cGTP) commensurate with Phase I/II clinical trials. The facility consists of controlled access Class 10,000 manufacturing suites, quarantined and released material areas, Quality Control laboratory, continuous process monitoring, USP purified water production, USP process gas farm, fully validated preparative equipment (autoclave, glasswash, depyrogenation oven) and biologics production equipment as required (incubators, centrifuges, bioreactors, chromatography equipment, etc.) The CBG is staffed with fully trained professionals who perform manufacturing, quality assurance and quality control functions as well as management staff with extensive biotechnology and pharmaceutical industry experience.

The CBG provides cGMP/cGTP quality clinical trials material for Projects 1, 2 and 4 of the SPORE. All manufacturing and release testing is performed according to standard operating procedures using materials that are inspected and released by the Quality Assurance Department. Manufacturing staff produces batch records of manufacturing runs that are reviewed by Quality Assurance prior to the release of any clinical materials. The Quality Control department performs raw material and release testing on drug intermediates and final products. Some testing (i.e. sterility, endotoxin) is performed by qualified third party providers including City of Hopes Microbiology and General Clinical Research Center laboratories.

The CBG is also capable of plasmid DNA production (to be used in Project 2) and has experience with the manufacturing of monoclonal antibodies (Projects 1 and 4) and T-cell products (Project 2). The staff of the CBG manages all support services such as equipment maintenance and calibration, cleaning, gowning, environmental monitoring and other facility-related activities

Career Development

Stephen J. Forman, M.D.
Director

John Rossi, Ph.D.
Co-Director
 
Review Committee Members
Andrew Raubitschek, M.D.
John Zaia, M.D.

The Career Development Program is devised to attract, train, and facilitate the success of young investigators pursuing careers in translational lymphoma research as well as provide a support mechanism for established investigators to refocus their work on lymphoma. This program provides fiscal support for one to three years to two individuals per year.

The program is implemented through the Administrative Core with SPORE Steering Committee, Executive Committee and External Advisory Board oversight. This program has well delineated processes for candidate recruitment, including an intensive effort to recruit women and minorities, an application, review, and selection process, a mentoring plan, a program of educational activities, and an evaluation process. In aggregate, this program insures that City of Hope is productive in contributing to the next generation of highly trained and lymphoma focused investigators that will contribute to translational lymphoma research.

Career Development Application Process
To apply for grant funds under the Career Development Program:

Contact Maggie Vigil at mvigil@coh.org to request the Pilot Grant Application.
You will then be emailed a Pilot Grant Application (Part One), along with a tracking number and instructions. To complete the application, you must include a brief program description.
Submit the completed Pilot Grant Application (Part One) as directed. You will need your tracking number to submit the application. 

All applications will undergo committee review, and selected applicants will be asked to submit additional program information. These selected applicants will be notified by email. The email notification will include using Pilot Grant Application (Part Two), and instructions for submitting this second application section. After committee review of Part Two applications, applicants whose requests are accepted will be notified.
 

Developmental Research

Stephen J. Forman, M.D.
Director

John A. Zaia, M.D.
Co-Director

Review Committee Members
David Colcher, Ph.D.
Michael Jensen, M.D.
Andrew Raubitschek, M.D.
John Rossi, Ph.D.

The primary objective of City of Hope ’s Cancer Center Lymphoma SPORE Developmental Research Program is to support high quality, innovative translational research projects that are not yet sufficiently mature for full program status despite having outstanding potential.

This goal is accomplished through the Developmental Research Program's capacity to identify conceptually novel and innovative hypothesis-driven projects spanning the spectrum of basic to medical science and clinical research pertaining to lymphoma, to provide fiscal support to allow sufficient development of these projects for subsequent funding as full SPORE projects or as independent projects funded by an independent peer-reviewed mechanism, and to provide intellectual/practical advice to Developmental Project leaders and foster collaborations to facilitate the translational process. This program imparts flexibility to the SPORE, allowing it to respond quickly to the latest developments in translational lymphoma research and to take maximal advantage of new technologies, opportunities for new collaborations, and novel ideas and approaches.

Under the auspices of the Administrative Core, Dr. Stephen Forman, SPORE PI, directs the Program in conjunction with the Developmental Research Program Committee, made up of highly regarded scientists and clinicians with interest and expertise in evaluating the translational potential of evolving lines of query pertaining to improving early detection, diagnosis, treatment or prevention of lymphoma.

The Administrative Core provides:

Dissemination of information about the Developmental Research Program within and outside City of Hope’s Comprehensive Cancer Center
Solicitation of applications
Organization of the activities of the Developmental Research Program Committee.

The Program provides up to $50,000 for one year per developmental project throughout the duration of the SPORE. Funds in this program can also be used to develop a new shared resource or establish a new technology within an existing shared resource, to support short-term collaborations with investigators in other institutions, or to purchase services for the SPORE in response to a recognized need. Developmental research projects from investigators within City of Hope’s Research community, as well from established collaborators outside the institution, are eligible for support.

Developmental Research Application Process

To apply for grant funds under the Developmental Research Program:

Contact Maggie Vigil at mvigil@coh.org to request the Pilot Grant Application.
You will then be emailed a Pilot Grant Application (Part One), along with a tracking number and instructions. To complete the application, you must include a brief program description.
Submit the completed Pilot Grant Application (Part One) as directed. You will need your tracking number to submit the application.

All applications will undergo committee review, and selected applicants will be asked to submit additional program information. These selected applicants will be notified by email. The email notification will include using Pilot Grant Application (Part Two), and instructions for submitting this second application section.

After committee review of Part Two applications, applicants whose requests are accepted will be notified.
 

Project 1

Anti-CD30 Radioimmunotherapy of Lymphoma:
Treatment of Hodgkin’s and CD30+ Non-Hodgkin’s Lymphoma

Andrew Raubitschek, M.D.
Principal Investigator

Eileen Smith, M.D.
Principal Investigator
 
Co-Investigators
David Colcher, Ph.D.
Stephen J. Forman, M.D.
Dave Yamauchi, M.D.

Although Hodgkin’s Lymphomas have one of the highest cure rates of any malignancy, patients with primary refractory disease and disease which relapses early after initial therapy are difficult to cure. This project is focused on the development of Anti-CD30 antibodies as a radioimmunotherapeutic for the treatment of CD30+ lymphomas, primarily Hodgkin’s Lymphoma.

Radioimmunotherapy offers an attractive therapeutic option, administering targeted radiation to sites of disease. Hodgkin’s Lymphoma is generally radiosensitive and radiation exerts its action in a non-cross resistant manner with combination chemotherapy. CD30, an antigen which was first defined on Hodgkin’s Lymphoma is an attractive target for therapeutics and is currently being evaluated in trials with unmodified human antibodies, immunotoxins, and radioimmunotherapy.

This grant focuses on Radioimmunotherapy using optimal anti-CD30 constructs including appropriate radioisotopes for a potentially internalizing antigen system. HeFi-1 will be the antibody for the first clinical trial, using radio heavy metal conjugated material, 111In for the imaging/dosimetry and 90Y for the therapy. The antibody is already prepared for clinical studies and is supplied through a NCI-RAID grant. The combination of radiometal with HeFi-1 should prove optimal for therapy and will represent the first time an anti-CD30 antibody will be evaluated as a radioimmunotherapeutic with a radiometal. This is an important feature for an internalizing antigen system where the heavy metal will remain bound intracellularly, in distinction from iodinated antibodies where isotope is released on intracellular metabolism .

The second objective focuses on the development of additional anti-CD30 antibody constructs, evaluating Ki-4 antibody which binds to a different CD30 cluster, as well as comparing three therapeutic isotopes, 131I, 90Y, 67Cu. Ki-4 has been used in clinical trials in Germany and a cell bank has been transferred to City of Hope for further development.

The third objective evaluates a series of anti-CD30 antibodies directed at the various epitopes of CD30 as carriers of radioisotopes and explore the potential of combining two or more antibodies for optimal internalization of the radioligand. The potential of controlling the shedding of CD30 from the surface of the tumor cells with metalloproteinase inhibitors will also be explored.

The fourth objective focuses on the molecular engineering of the most promising anti-CD30 antibody as an optimal radioimmunotherapeutic exploring the scFv dimers (diabody) as well as minibody format.

Project 2

Cellular Immunotherapy for B-Lineage Lymphoma Using Engineered CD19-Specific T-cells

Michael Jensen, M.D.
Principal Investigator

Auayporn P. Nademanee, M.D.
Principal Investigator

Co-Investigators

Leslie Popplewell, M.D.
 
Currently available therapeutics for relapsed/advanced B-cell lymphomas, such as diffuse large B-cell lymphoma (DLBCL), have limited curative potential and significant toxicities, particularly for the older patient population. Novel treatment modalities are needed, such as immunotherapy, which can combine enhanced anti-tumor efficacy with diminished toxicities through targeting of malignant B-cells.

The studies in Project 2 build upon City of Hope ’s non-viral gene transfer methodologies for isolating and expanding genetically modified human T-cells. This has resulted in the design of a chimeric immunoreceptor that redirects the specificity of CD8+ cytotoxic T-lymphocytes (CTL’s) to CD19, a B-lineage cell-surface marker that is expressed on B-cell lymphomas. Although CD19-specific CD8+ T-cells can directly recognize and efficiently lyse lymphoma targets in vitro and in vivo, a variety of model systems and clinical adoptive immunotherapy trials have highlighted the importance of a CD4+ T-cell helper response for providing growth factors, such as IL-2, to support the persistence and expansion of CTL-effectors. To develop CD19-specific T-cells that are capable of sustaining an antigen-specific helper-response, we are developing and evaluating the ability of CD19-specific CD4+ T-cells to be activated for a TH1 response by CD19+ lymphoma cells. The full activation of CD4+ T-cells for IL-2 synthesis is dependent on signaling through both the T-cell receptor and co-stimulatory molecules.

Therefore, our second goal is to address the role of co-stimulation in general to achieve full-activation of CD19-specific helper T-cells. In particular, we will evaluate the ability of CD19-specific CD4+ T-cells to secrete IL-2 in response to CD28-costimulation mediated in cis and trans with binding of the CD19-specific chimeric immunoreceptor by CD19+ lymphoma. Our third objective is to model the anti-tumor activity of CD19-specific CD4+ T-cells in vivo by evaluating whether co-transfer of CD19-specific CD4+ T-cells can enhance the persistence and anti-tumor activity of CD19-specific CD8+ T-cells in NOD/scid mice bearing CD19+ lymphoma. A clinical trial employing the co-transfer of both CD19-specific CD8+ CTL’s and CD4+ TH1 help will require additional process development during the initial years of SPORE funding. Therefore, protocols will be developed to infuse T-cell products that have been thawed at the bedside, to incorporate high-capacity electroporation devices, perfusion bioreactors and washing/concentrating methods into closed fluid pathways, to eliminate serum from the T-cell culture media, and to use paramagnetic bead-selection to isolate desired T-cell populations.

We anticipate that these preclinical studies will form the basis of 2nd generation adoptive immunotherapy trial to evaluate the safety/feasibility/efficacy of combining CD4+ and CD8+ CD19-specific T-cells for advanced DLBCL.

Project 3

Therapy-Related Leukemia Following Autologous Transplantation for Lymphoma
 
Ravi Bhatia, M.D.
Principal Investigator
 
Smita Bhatia , M.D.
Principal Investigator

Co-Investigator
Timothy O’Connor, Ph.D.

Autologous peripheral blood stem cell transplantation (aPBSCT) is an effective treatment approach for patients with refractory or relapsed Hodgkin's Lymphoma (HL) and non-Hodgkin's Lymphoma (NHL). However, this treatment approach is associated with a high incidence of therapy-related myelodysplasia and acute myeloid leukemia (t-MDS/AML), which is now recognized as a major cause of non-relapse mortality.

Epidemiological studies indicate that stem cell damage from pre-transplant and transplant-related therapeutic exposures may contribute to the pathogenesis of t-MDS/AML following aPBSCT. However, the mechanisms underlying susceptibility to t-MDS/AML and the sequence of cellular and molecular abnormalities leading to transformation remain unknown. We have initiated a prospective, longitudinal evaluation of patients with HL/NHL undergoing aPBSCT. Patients are being followed longitudinally at multiple time-points from before aPBSCT to several years post-transplant, with serial collection and banking of blood and marrow samples, to allow investigation of factors that predict for the development of t-MDS/AML, and to follow the sequence of events leading to its development.

Investigators with expertise in epidemiology, DNA repair and hematopoiesis will investigate the hypothesis that pre-transplant and transplant-related therapeutic exposures in concert with defects in DNA repair mechanisms (Goal 1) and DNA damage response (Goal 2) are associated with development of detectable hematopoietic abnormalities (Goal 3) that antedate and predict for the development of t-MDS/AML among patients undergoing aPBSCT for HL/NHL. We will determine the sequence of acquisition of abnormalities in DNA repair mechanisms, DNA damage response, hematopoietic and cytogenetic abnormalities in the course of development of t-MDS/AML (Goal 4), and investigate the potential role of the above abnormalities, therapeutic exposures and demographic variables in determining the risk of t-MDS/AML (Goal 5).

Successful completion of these studies will provide insights into the pathogenesis of t-MDS/AML will allow accurate assessment of risk factors for t-MDS/AML following lymphoma therapy and detection of patients at early stages of leukemogenesis. Identification of biomarker s for HL and NHL patients at increased risk of development of t-MDS/AML, may aid modification of treatment regimens to reduce risk of this complication.

Project 4

Molecularly Engineered Constructs for anti CD20 Directed Therapeutics: Imaging, Radioimmunotherapy, and Fusion Proteins
 
Andrew Raubitschek, M.D.
Principal Investigator
 
Auayporn Nademanee, M.D.
Principal Investigator

Co-Investigators
David Colcher, Ph.D.
Ryotaro Nakamura, M.D.
Anna Wu, Ph.D.
Dave Yamauchi, M.D.

Project 4 focuses on improving antibody based immunotherapy for the treatment of CD20-positive Non-Hodgkin’s Lymphoma utilizing two different mechanisms. The first two specific objectives focus on the development of anti-CD20 antibodies as carriers of radioactivity for the purpose of achieving better imaging and more effective treatment of NHL. Although there are soon to be two FDA approved radioimmunotherapeutics for CD20+ NHL, they offer the opportunity to build on their success with reagents specifically designed as carriers of radioisotopes.

The first specific objective will develop molecularly engineered antibody fragments for imaging lymphoma, building on our successful experience with engineering CEA antibodies, focusing on diabodies and minibodies which should provide both faster targeting and more rapid clearance from the blood stream thereby providing better images of sites of lymphomatous disease. With the advent of PET scanners, faster targeting reagents are required to take advantage of the general shorter half lives of positron emitting isotopes. Although these agents are being evaluated in solid tumors, this will be the first time they will be investigated in lymphomas, where we hypothesize that they will show improved performance given the different relationship of lymphomas to the vascular supply. Refinements in reagents used for tumor imaging are not only worthwhile as imaging agents in B-cell lymphoma but also will verify in the given patient whether the target antigen is present for a range of novel immune directed therapeutics.

The second objective focuses on the therapeutic aspect of radioimmunoconjugates, defining by molecular engineering the optimal characteristics for improved radioimmunotherapy. The desired features of the antibody are likely to be different than that for imaging since a longer residence time at the tumor site is needed for better therapeutic applications. The third focus of the project deals with the utilizing antibodies to carry immunologic agents to sites of tumor. The success of Rituxan in the treatment of lymphoma confirms the important role of the immune system as an anti-cancer therapeutic. In this project we will conduct laboratory and clinical studies of the anti-CD20-IL-2 fusion protein which has significant pre-clinical therapeutic activity, by harnessing the tumor localization capabilities of the antibody to the cellular potency of IL2 in activating lymphocytes. We will conduct clinical trials of a humanized (deImmunized) antiCD20-IL2 immunocytokine to determine the activity of this novel reagent in the treatment of relapsed B-cell lymphoma. This aim provides an important opportunity for additional translational research as the patient studies will allow an in depth exploration of the mechanisms by which the endogenous immune system can be harnessed to destroy lymphoma.

These studies will be important for understanding the immune mechanisms necessary for optimal development of effective immune system based therapeutics for lymphoma as well as for other malignancies in humans.

Tissue Bank for Cellular and Molecular Studies

Lawrence Weiss, M.D.
Director

Ravi Bhatia, M.D.
Co-Director

Co-Investigators
Smita Bhatia , M.D.
Karen Chang, M.D.

The tissue core facilitates research on lymphoid malignancies by members of City of Hope sComprehensive Cancer Centerand supports two tissue banks.

The Pathology tissue bank core provides services in the following areas:

Acquisition and banking of fresh and paraffin-fixed tissues of lymphoma patients at City of Hope, including specimens obtained prospectively and retrospectively obtaining specimens from patients previously biopsied elsewhere;
Comprehensive work-up of lymphoma specimens to ensure correct diagnosis and classification, including immunohistochemical, molecular pathologic, and cytogenetic studies.
Performance and assistance in routine histologic processing and immunohistochemical staining of lymphoma tissues, including paraffin embedding, sectioning and H&E staining of human tissue, animal tissue, and preparations from cell lines, as well as specialized histologic services such as preparation of multitumor blocks or tissue microarrays to the specifications of researchers;
Performance and assistance in Laser Capture microdissections from paraffin or frozen sections to obtain enrichment of specific cell types including isolation of malignant cells for analysis of proteins, RNA and/or DNA content.
Consultation services to other SPORE investigators.

The Hematopoietic cell tissue bank collects bone marrow, peripheral blood and peripheral blood stem cell samples from lymphoma patients undergoing autologous peripheral stem cell transplant (aPBSCT). This core prospectively collects and stores fresh blood and marrow samples from patients undergoing aPBSCT for lymphoma. Samples are obtained pre-transplant and post-transplant at 100 days, 6 months, 1 year, and then annually through 5 years after transplant. In addition, aliquots of the PBSC autograft are also banked. The core also collects and enters follow up outcome information for all patients.

The core uses an IRB approved protocol for sample and data collection. The core also follows patients who have received their initial transplant treatment but who are not under current follow-up at City of Hope, by contacting the treating physician, and if necessary, recalling the patient to City of HopesGeneral Clinical Research Centerfor clinical evaluation, blood draw and bone marrow biopsy .
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