Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
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| ClinicalTrials.gov Identifier: NCT00003396 |
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Recruitment Status :
Completed
First Posted : June 3, 2004
Last Update Posted : October 17, 2019
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RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation from related donors to prevent graft-versus-host disease in treating patients with hematologic cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes | Biological: anti-thymocyte globulin Biological: graft-versus-tumor induction therapy Drug: cyclophosphamide Drug: melphalan Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy | Phase 2 |
OBJECTIVES: I. Evaluate the use of donor peripheral blood stem cells without graft-versus-host disease prophylaxis to maximize the probability of graft-versus-tumor effect in patients with hematologic malignancies refractory to standard chemotherapy and unlikely to be cured with high dose chemotherapy and radiotherapy.
OUTLINE: Prior to peripheral blood stem cell transplant, patients undergo preparative cytoreduction. Patients receive total body irradiation (TBI) beginning on day -5. Radiotherapy is administered in 9 doses over 3 days (3 doses per day for 3 days). Male patients with acute lymphocytic leukemia receive an additional dose of radiation to the testicles. Patients who are ineligible for TBI due to prior radiotherapy receive 2 doses of melphalan IV on day -3. All patients receive cyclophosphamide IV over 1 hour on days -2 and -1. Anti-thymocyte globulin is also administered IV over 6 hours on days -2 and -1. Approximately 24-36 hours after the last dose of cyclophosphamide, peripheral blood stem cells obtained from the HLA matched related donor are infused into the patient. Patients do not receive graft-versus-host disease prophylaxis after transplant; however, all other forms of supportive care are provided. Patients are followed for 1 year.
PROJECTED ACCRUAL: A maximum of 42 patients will be accrued for this study.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 42 participants |
| Primary Purpose: | Treatment |
| Official Title: | Evaluation of Allogeneic Peripheral Blood Stem Cell Transplants From a Related Donor Without Graft-Versus-Host Prophylaxis in Patients With High Risk of Relapse |
| Study Start Date : | September 1998 |
| Actual Primary Completion Date : | December 2002 |
| Actual Study Completion Date : | December 2002 |
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| Ages Eligible for Study: | up to 120 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Patients with HLA identical family donors and any one of the following conditions documented by marrow aspiration and biopsy: -Acute leukemia refractory to induction treatment or after 1 or more relapses -Acute myeloid leukemia with t(9;22), -5/5q-, -7/7q-, and 11q23 involvement in first remission (not M4 or M5) -Acute lymphocytic leukemia with t(9;22) or t(4;11) in first remission -Myelodysplastic syndrome with greater than 5% bone marrow blasts -Chronic myeloid leukemia in accelerated phase or nonlymphoid blast crisis -Myeloma, chronic lymphocytic leukemia, non-Hodgkin's lymphoma, or Hodgkin's disease refractory to 2 lines of standard treatment or progression on standard treatment No evidence of active extramedullary disease
PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 70-100% Life expectancy: Greater than 8 weeks Hematopoietic: Not specified Hepatic: Bilirubin less than 2.0 mg/dL SGOT no greater than 4 times upper limit of normal and not increasing for 2-4 weeks prior to transplant Renal: Creatinine less than 2 times normal and not increasing for 2-4 weeks prior to transplant OR Creatinine clearance greater than 60 mL/min Cardiovascular: LVEF greater than 50% by MUGA Pulmonary: DLCO greater than 50% Other: Not HIV positive Not pregnant or nursing Fertile patients must use effective contraceptive
PRIOR CONCURRENT THERAPY: See Disease Characteristics
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): NCT00003396
| United States, Maryland | |
| Marlene & Stewart Greenebaum Cancer Center, University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| Study Chair: | Barry R. Meisenberg, MD | University of Maryland Greenebaum Cancer Center |
| Responsible Party: | UM Greenebaum Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00003396 |
| Other Study ID Numbers: |
CDR0000066397 MSGCC-9805 NCI-V98-1430 |
| First Posted: | June 3, 2004 Key Record Dates |
| Last Update Posted: | October 17, 2019 |
| Last Verified: | October 2019 |
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recurrent childhood acute lymphoblastic leukemia recurrent adult Hodgkin lymphoma refractory multiple myeloma Waldenstrom macroglobulinemia stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma recurrent childhood lymphoblastic lymphoma recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia |
adult acute myeloid leukemia in remission adult acute lymphoblastic leukemia in remission childhood acute myeloid leukemia in remission childhood acute lymphoblastic leukemia in remission adult acute erythroid leukemia (M6) adult acute myeloblastic leukemia without maturation (M1) adult acute myeloblastic leukemia with maturation (M2) adult acute promyelocytic leukemia (M3) adult acute eosinophilic leukemia adult acute basophilic leukemia adult acute megakaryoblastic leukemia (M7) childhood acute myeloblastic leukemia without maturation (M1) childhood acute myeloblastic leukemia with maturation (M2) childhood acute promyelocytic leukemia (M3) childhood acute erythroleukemia (M6) |
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Lymphoma Leukemia Multiple Myeloma Neoplasms, Plasma Cell Preleukemia Myelodysplastic Syndromes Syndrome 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 Melphalan Antilymphocyte Serum Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |