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| Sponsored by: |
Roswell Park Cancer Institute |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003816 |
Purpose
RATIONALE: Giving chemotherapy drugs and total-body irradiation before a donor stem cell helps stop the growth of cancer or abnormal cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It is not yet known which combination chemotherapy regimen is most effective when given before a donor stem cell transplant in treating aplastic anemia or hematologic cancer.
PURPOSE: This phase II/III trial is studying different combination chemotherapy regimens to compare how well work when given before donor stem cell transplant in treating patients with aplastic anemia or hematologic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myeloproliferative Disorders Leukemia Lymphoma Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Precancerous/Nonmalignant Condition Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific |
Biological: anti-thymocyte globulin Drug: busulfan Drug: carboplatin Drug: cyclophosphamide Drug: etoposide Drug: fludarabine phosphate Drug: melphalan Drug: thiotepa Radiation: total-body irradiation |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Allogeneic Blood or Marrow Transplantation for Hematologic Malignancy and Aplastic Anemia |
| Estimated Enrollment: | 405 |
| Study Start Date: | October 1998 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Regimen 1: Experimental
Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.
|
Drug: busulfan
Given IV
Drug: cyclophosphamide
Given IV
|
|
Regimen 2: Experimental
Patients receive cyclophosphamide IV over 2 hours on days -5 to -2 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -3.
|
Biological: anti-thymocyte globulin
Given IV
Drug: cyclophosphamide
Given IV
|
|
Regimen 3: Experimental
Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and total-body irradiation (TBI) twice daily on days -3 to -1.
|
Drug: cyclophosphamide
Given IV
Radiation: total-body irradiation
Given twice daily for 3 days
|
|
Regimen 4: Experimental
Patients receive fludarabine IV over 30 minutes on days -6 to -2 and melphalan IV over 1 hour on days -3 and -2.
|
Drug: fludarabine phosphate
Given IV
Drug: melphalan
Given IV
|
|
Regimen 5: Experimental
Patients receive etoposide IV over 26 hours beginning on day -5, cyclophosphamide IV over 2 hours on day -4, and TBI twice daily on days -3 to -1.
|
Drug: cyclophosphamide
Given IV
Drug: etoposide
Given IV
Radiation: total-body irradiation
Given twice daily for 3 days
|
|
Regimen 6: Experimental
Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4.
|
Drug: carboplatin
Given IV
Drug: cyclophosphamide
Given IV
Drug: thiotepa
Given IV
|
|
Regimen 7: Experimental
Patients receive fludarabine IV over 30 minutes on days -5 to -1 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -2.
|
Biological: anti-thymocyte globulin
Given IV
Drug: fludarabine phosphate
Given IV
|
|
Regimen 8: Experimental
Patients receive cyclophosphamide IV over 2 hours on days -5 and -4, TBI twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4-8 hours on days -3 to -1.
|
Biological: anti-thymocyte globulin
Given IV
Drug: cyclophosphamide
Given IV
Radiation: total-body irradiation
Given twice daily for 3 days
|
|
Regimen 9: Experimental
Patients receive busulfan IV over 2 hours every 6 hours and anti-thymocyte globulin IV over 4-8 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.
|
Biological: anti-thymocyte globulin
Given IV
Drug: busulfan
Given IV
Drug: cyclophosphamide
Given IV
|
OBJECTIVES:
OUTLINE: Patients are stratified according to risk of relapse (standard-risk: acute leukemia in first complete remission, chronic myelogenous leukemia in first chronic phase, lymphoma in sensitive first relapse or second remission, primary or untreated myelodysplastic syndromes, or untreated severe aplastic anemia vs high-risk: all others).
Patients are assigned to one of the following conditioning regimens based on diagnosis, risk of relapse, and donor relatedness:
Regimen 5: Patients receive etoposide IV over 26 hours beginning on day -5, cyclophosphamide IV over 2 hours on day -4, and TBI twice daily on days
Patients are followed periodically post-transplant.
PROJECTED ACCRUAL: At least 405 patients will be accrued for this study within 5 years.
Eligibility| Ages Eligible for Study: | 4 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of one of the following:
Severe aplastic anemia as defined by either of the following:
At least 2 of the following abnormal peripheral blood counts:
Histologically confirmed hematologic malignancy, including any of the following:
Acute leukemia
Chronic myeloid leukemia (CML)
Myeloproliferative disorders or MDS, including any of the following:
Lymphoproliferative disease
Recurrent or persistent, symptomatic disease after first-line chemotherapy, including any of the following:
Intermediate or high-grade non-Hodgkin lymphoma, meeting 1 of the following criteria:
Autologous bone marrow transplant not possible (or desirable) due to 1 of the following:
Histocompatible donor identified
Well-matched donor, as defined by 1 of the following:
NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma.
However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
No other serious organ dysfunction (unless due to underlying disease), including the following:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Not eligible for total-body irradiation if prior radiotherapy exceeded the following limits:
Surgery:
Contacts and Locations| United States, New York | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263-0001 | |
| Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724 | |
| Study Chair: | Philip L. McCarthy, MD | Roswell Park Cancer Institute |
More Information
| Responsible Party: | Roswell Park Cancer Institute ( Philip L. McCarthy, Jr ) |
| Study ID Numbers: | CDR0000066968, RPCI-RP-9815, NCI-V99-1527 |
| Study First Received: | November 1, 1999 |
| Last Updated: | June 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003816 History of Changes |
| Health Authority: | Unspecified |
|
recurrent childhood acute lymphoblastic leukemia recurrent cutaneous T-cell non-Hodgkin lymphoma Burkitt lymphoma Waldenstrom macroglobulinemia 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 chronic phase chronic myelogenous 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 polycythemia vera essential thrombocythemia refractory anemia refractory anemia with excess blasts refractory anemia with excess blasts in transformation chronic myelomonocytic leukemia T-cell large granular lymphocyte leukemia acute undifferentiated leukemia recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma |
|
Blast Crisis Aplastic Anemia Mantle Cell Lymphoma Refractory Anemia Preleukemia Leukemia, Prolymphocytic Lymphoma, Large-Cell, Anaplastic Neoplasm Metastasis Thrombocythemia, Hemorrhagic Etoposide Myelodysplastic Myeloproliferative Disease Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic |
Leukemia, Myeloid Thiotepa Waldenstrom Macroglobulinemia Leukemia, Myeloid, Accelerated Phase Chronic Myelogenous Leukemia Fludarabine Lymphoma, Non-Hodgkin Precancerous Conditions Immunologic Factors Lymphoma, Follicular Sezary Syndrome Lymphoblastic Lymphoma Lymphoma, B-Cell Leukemia Cutaneous T-cell Lymphoma |
|
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Precancerous Conditions Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Leukemia Preleukemia Pathologic Processes Therapeutic Uses Syndrome Anemia, Aplastic Alkylating Agents |
Lymphoma Neoplasms by Histologic Type Immunoproliferative Disorders Disease Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Anemia Myeloproliferative Disorders Fludarabine monophosphate Carboplatin Immunosuppressive Agents Pharmacologic Actions Antilymphocyte Serum Lymphatic Diseases |