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Bone Marrow Transplantation in Treating Patients With Hematologic Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003398
First Posted: April 27, 2004
Last Update Posted: September 24, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Maryland Greenebaum Cancer Center
Information provided by:
University of Maryland
  Purpose

RATIONALE: Bone marrow that has been treated to remove certain white blood cells may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy, and may reduce the chance of developing graft-versus-host disease following bone marrow transplantation.

PURPOSE: Phase IV trial to study the incidence of graft-versus-host disease in patients who have hematologic cancer and who are undergoing bone marrow transplantation from a donor.


Condition Intervention Phase
Anemia Graft Versus Host Disease Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Biological: anti-thymocyte globulin Biological: filgrastim Drug: cyclophosphamide Drug: thiotepa Procedure: allogeneic bone marrow transplantation Procedure: bone marrow ablation with stem cell support Radiation: radiation therapy Phase 4

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Evaluation of Allogeneic Marrow Transplants Depleted of T-Cells by CD34+ Selection in Patients Undergoing Transplantation With an Unrelated Matched or 1 Antigen Mismatched Donor or a 1 Antigen Mismatched Related Donor

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Estimated Enrollment: 45
Study Start Date: September 1998
Study Completion Date: May 2000
Primary Completion Date: May 2000 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Evaluate the incidence of acute graft versus host disease in patients undergoing transplantation with an unrelated or related matched or mismatched antigen donor. II. Evaluate the rapidity of engraftment and CD4 count recovery post-transplantation in this patient population.

OUTLINE: Patients receive total body irradiation (TBI) three or two times a day on days -8 to -5. Following TBI, patients receive thiotepa IV over 4 hours daily on days -4 and -3 plus cyclophosphamide IV over 1 hour daily on days -2 and -1. Antithymocyte globulin is administered by IV over at least 4 hours on days -4 to -1. Patients undergo an allogenic bone marrow transplantation on day 0. Bone marrow is harvested from patient's donor, depleted of T-cells, and infused. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 4.

PROJECTED ACCRUAL: Approximately 26-45 patients will be accrued for this study within 3-4 years.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven malignancy or condition of the following types: Acute myelogenous leukemia (not M5 or M6) or lymphocytic leukemia in first or greater remission or early relapse OR Chronic myelogenous leukemia OR Myelodysplastic syndrome OR Aggressive or refractory non-Hodgkin's lymphoma OR Aggressive or refractory Hodgkin's disease OR Multiple myeloma at early relapse or after conventional chemotherapy to reduce tumor mass OR High risk chronic lymphocytic leukemia OR Aplastic anemia HLA-matched or 1 antigen mismatched (related or unrelated) available as donor

PATIENT CHARACTERISTICS: Age: 50 and under Performance status: Karnofsky 70-100% Life expectancy: Greater than 8 weeks Hematopoietic: Not specified Hepatic: Bilirubin less than 2 mg/dL SGOT less than 4 times upper limit of normal (ULN) Renal: Creatinine less than 2 times ULN OR Creatinine clearance greater than 60 mL/min Cardiovascular: LVEF at least 50% by MUGA Pulmonary: DLCO at least 50% Other: HIV negative No active extramedullary disease Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: See Disease Characteristics

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003398


Locations
United States, Maryland
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
University of Maryland Greenebaum Cancer Center
Investigators
Study Chair: Barry R. Meisenberg, MD University of Maryland Greenebaum Cancer Center
  More Information

Responsible Party: UM Greenebaum Cancer Center
ClinicalTrials.gov Identifier: NCT00003398     History of Changes
Other Study ID Numbers: CDR0000066400
MSGCC-9739
NCI-V98-1433
First Submitted: November 1, 1999
First Posted: April 27, 2004
Last Update Posted: September 24, 2009
Last Verified: September 2009

Keywords provided by University of Maryland:
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
recurrent childhood acute lymphoblastic leukemia
recurrent adult Hodgkin lymphoma
Burkitt lymphoma
refractory multiple myeloma
Waldenstrom macroglobulinemia
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
stage I childhood lymphoblastic lymphoma
stage II childhood lymphoblastic lymphoma
stage III childhood lymphoblastic lymphoma
stage IV childhood lymphoblastic lymphoma
recurrent childhood lymphoblastic lymphoma
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
recurrent childhood acute myeloid leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
refractory chronic lymphocytic leukemia
childhood diffuse large cell lymphoma
childhood immunoblastic large cell lymphoma
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
meningeal chronic myelogenous leukemia
adult acute myeloid leukemia in remission

Additional relevant MeSH terms:
Lymphoma
Syndrome
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Graft vs Host Disease
Plasmacytoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions
Cyclophosphamide
Thiotepa
Antilymphocyte Serum
Immunosuppressive Agents