Bone Marrow Transplant in Treating Patients With Hematologic Cancers
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|ClinicalTrials.gov Identifier: NCT00005797|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 25, 2012
RATIONALE: Giving chemotherapy drugs and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells. It also helps 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.
PURPOSE: This phase II trial is studying how well donor bone marrow transplant works in treating patients with hematologic cancers.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloproliferative Disorders Leukemia Multiple Myeloma and Malignant Plasma Cell Neoplasms Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms||Drug: busulfan Drug: Cyclophosphamide Drug: VP-16 Radiation: Fractionated Total Body Irradiation (FTBI)||Phase 2|
- Determine the progression free survival (PFS) and overall survival (OS) of patients with low risk myeloid disorders or older allogeneic recipients who are treated with high dose busulfan and cyclophosphamide and allogeneic bone marrow transplantation (BMT).
- Determine the PFS and OS in patients with lymphoid and high risk myeloid disorders who are treated with etoposide, total body irradiation, and allogeneic BMT.
- Evaluate the toxicities of these 2 regimens when combined with cyclosporine and methotrexate as graft versus host disease prophylaxis in these patients.
- Evaluate the PFS and OS of allogeneic BMT in patients with multiple myeloma and chronic lymphocytic leukemia.
- Regimen A: Patients with chronic myelogenous leukemia (CP1, AP/CP2) and other myeloproliferative disorders, myelodysplastic disorders, acute myelogenous leukemia (CR1), or multiple myeloma (not eligible to receive total body irradiation due to prior radiation) are treated with high dose busulfan and cyclophosphamide followed by allogeneic bone marrow transplantation (BMT). Patients receive oral busulfan every 6 hours on days -7 to -4 and cyclophosphamide IV over 1 hour on days -3 and -2. Allogeneic bone marrow is infused on day 0.
- Regimen B: Patients with acute myelogenous leukemia (at least CR2, relapsed), acute lymphoid leukemia (ALL), any acute leukemia with CNS involvement, multiple myeloma, or chronic lymphocytic leukemia are treated with total body irradiation and etoposide followed by allogeneic BMT. Patients receive total body irradiation (TBI) on days -7 to -4 for a total of 11 fractions and etoposide IV over 4 hours on day -3. Male patients with ALL receive a testicular boost in 2 fractions on 2 successive days during TBI. Allogeneic bone marrow is infused on day 0.
Patients in both regimens receive cyclosporine and methotrexate as graft versus host disease prophylaxis.
Patients are followed weekly for 3 months and then monthly for 1 year.
PROJECTED ACCRUAL: At least 50 patients with low risk myeloid disease, 50 patients with lymphoid malignancies, and 60 patients with high risk myeloid disease will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||125 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Allogeneic Bone Marrow Transplantation for Hematologic Malignancies: A Treatment Approach Based on Risk of Relapse and Toxicity|
|Study Start Date :||March 1993|
|Primary Completion Date :||July 2007|
|Study Completion Date :||July 2007|
Busulfan & Cyclophosphamide
administered on Day -7 through Day -4. The total dose is 12.8 mg/kg
Other Name: Busulfex®Drug: Cyclophosphamide
administered at a dose of 60 mg/kg on each of two successive days (Days -3 and -2)
Fractionated Total Body Irradiation + VP-16
administered as a single infusion on Day -3. The dose is 60 mg/kg and is calculated on actual body weight unless the patient's weight is >/= 150% of IBW, in which case adjusted body weight will be used.
Other Name: Etoposide (VP-16; Vepesid(R) brand only)Radiation: Fractionated Total Body Irradiation (FTBI)
FTBI is performed on day -7 through day -4. The total dose of radiation is 1,320 cGy.
- Relapse-free survival [ Time Frame: 5 years post transplant ]Relapse free survival 5 post transplant deteremiend by the Kaplan-Meier product-limit method.
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): NCT00005797
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute at University of South Florida|
|Tampa, Florida, United States, 33612-9497|
|Study Chair:||Teresa Field, MD, PhD||H. Lee Moffitt Cancer Center and Research Institute|