High-Dose Busulfan and High-Dose Cyclophosphamide Followed By Donor Bone Marrow Transplant in Treating Patients With Leukemia, Myelodysplastic Syndrome, Multiple Myeloma, or Recurrent Hodgkin or Non-Hodgkin Lymphoma
NCT01177371 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2010-08-09
Summary
RATIONALE: Giving high doses of chemotherapy drugs, such as busulfan and cyclophosphamide, before a donor bone marrow transplant helps stop the growth of cancer 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine, methylprednisolone, and methotrexate after transplant may stop this from happening.
PURPOSE: This clinical trial studies high-dose busulfan and high-dose cyclophosphamide followed by donor bone marrow transplant in treating patients with leukemia, myelodysplastic syndrome, multiple myeloma, or recurrent Hodgkin or Non-Hodgkin lymphoma.
Conditions
- Accelerated Phase Chronic Myelogenous Leukemia
- Adult Acute Lymphoblastic Leukemia in Remission
- Adult Acute Megakaryoblastic Leukemia (M7)
- Adult Acute Monoblastic Leukemia (M5a)
- Adult Acute Monocytic Leukemia (M5b)
- Adult Acute Myeloblastic Leukemia With Maturation (M2)
- Adult Acute Myeloblastic Leukemia Without Maturation (M1)
- Adult Acute Myeloid Leukemia in Remission
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Adult Acute Myeloid Leukemia With Del(5q)
- Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- Adult Acute Myeloid Leukemia With T(15;17)(q22;q12)
- Adult Acute Myeloid Leukemia With T(16;16)(p13;q22)
- Adult Acute Myeloid Leukemia With T(8;21)(q22;q22)
- Adult Acute Myelomonocytic Leukemia (M4)
- Adult Acute Promyelocytic Leukemia (M3)
- Adult Erythroleukemia (M6a)
- Adult Nasal Type Extranodal NK/T-cell Lymphoma
- Adult Pure Erythroid Leukemia (M6b)
- Anaplastic Large Cell Lymphoma
- Angioimmunoblastic T-cell Lymphoma
- Burkitt Lymphoma
- Childhood Acute Erythroleukemia (M6)
- Childhood Acute Lymphoblastic Leukemia in Remission
- Childhood Acute Megakaryocytic Leukemia (M7)
- Childhood Acute Monoblastic Leukemia (M5a)
- Childhood Acute Monocytic Leukemia (M5b)
- Childhood Acute Myeloblastic Leukemia With Maturation (M2)
- Childhood Acute Myeloblastic Leukemia Without Maturation (M1)
- Childhood Acute Myeloid Leukemia in Remission
- Childhood Acute Myelomonocytic Leukemia (M4)
- Childhood Acute Promyelocytic Leukemia (M3)
- Childhood Chronic Myelogenous Leukemia
- Childhood Myelodysplastic Syndromes
- Chronic Phase Chronic Myelogenous Leukemia
- Cutaneous B-cell Non-Hodgkin Lymphoma
- De Novo Myelodysplastic Syndromes
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- Hepatosplenic T-cell Lymphoma
- Intraocular Lymphoma
- Nodal Marginal Zone B-cell Lymphoma
- Peripheral T-Cell Lymphoma
- Post-transplant Lymphoproliferative Disorder
- Previously Treated Myelodysplastic Syndromes
- Recurrent Adult Acute Lymphoblastic Leukemia
- Recurrent Adult Acute Myeloid Leukemia
- Recurrent Adult Burkitt Lymphoma
- Recurrent Adult Diffuse Large Cell Lymphoma
- Recurrent Adult Diffuse Mixed Cell Lymphoma
- Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
- Recurrent Adult Grade III Lymphomatoid Granulomatosis
- Recurrent Adult Hodgkin Lymphoma
- Recurrent Adult Immunoblastic Large Cell Lymphoma
- Recurrent Adult Lymphoblastic Lymphoma
- Recurrent Adult Non-Hodgkin Lymphoma
- Recurrent Adult T-cell Leukemia/Lymphoma
- Recurrent Childhood Acute Lymphoblastic Leukemia
- Recurrent Childhood Acute Myeloid Leukemia
- Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
- Recurrent Grade 1 Follicular Lymphoma
- Recurrent Grade 2 Follicular Lymphoma
- Recurrent Grade 3 Follicular Lymphoma
- Recurrent Mantle Cell Lymphoma
- Recurrent Marginal Zone Lymphoma
- Recurrent Mycosis Fungoides/Sezary Syndrome
- Recurrent Small Lymphocytic Lymphoma
- Refractory Multiple Myeloma
- Relapsing Chronic Myelogenous Leukemia
- Secondary Myelodysplastic Syndromes
- Small Intestine Lymphoma
- Splenic Marginal Zone Lymphoma
- Testicular Lymphoma
- Waldenstrom Macroglobulinemia
Interventions
- DRUG
-
busulfan
Given orally
- DRUG
-
Given IV
- PROCEDURE
-
allogeneic bone marrow transplantation
Patients undergo allogeneic bone marrow transplant IV over 2-3 hours on day 0.
- DRUG
-
methylprednisolone
Given IV or orally
- DRUG
-
methotrexate
Given IV
- DRUG
-
cyclosporine
Given IV or orally
Sponsors & Collaborators
-
Case Comprehensive Cancer Center
lead OTHER
Principal Investigators
-
Hillard Lazarus · Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1988-03-31
- Primary Completion
- 2000-02-29
- Completion
- 2010-02-28
Countries
- United States
Study Locations
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