Haploidentical Donor Bone Marrow Transplant in Treating Patients With High-Risk Hematologic Cancer
NCT00049504 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53
Last updated 2017-05-17
Summary
This phase II trial studies how well giving fludarabine phosphate, cyclophosphamide, tacrolimus, mycophenolate mofetil and total-body irradiation together with a donor bone marrow transplant works in treating patients with high-risk hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate and cyclophosphamide, and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells by stopping them from dividing or killing them. Giving cyclophosphamide after transplant may also stop the patient's immune system from rejecting the donor's bone marrow stem cells. The donated stem cells may replace the patient's immune system cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil after the transplant may stop this from happening
Conditions
- Stage III Adult Immunoblastic Large Cell Lymphoma
- Stage III Adult Lymphoblastic Lymphoma
- Stage III Adult T-cell Leukemia/Lymphoma
- Stage III Childhood Hodgkin Lymphoma
- Stage III Chronic Lymphocytic Leukemia
- Stage III Cutaneous T-cell Non-Hodgkin Lymphoma
- Stage III Grade 1 Follicular Lymphoma
- Stage III Grade 2 Follicular Lymphoma
- Stage III Grade 3 Follicular Lymphoma
- Stage III Mantle Cell Lymphoma
- Stage III Marginal Zone Lymphoma
- Stage III Multiple Myeloma
- Stage III Mycosis Fungoides/Sezary Syndrome
- Stage III Small Lymphocytic Lymphoma
- Stage IV Adult Burkitt Lymphoma
- Stage IV Adult Diffuse Large Cell Lymphoma
- Stage IV Adult Diffuse Mixed Cell Lymphoma
- Stage IV Adult Diffuse Small Cleaved Cell Lymphoma
- Stage IV Adult Hodgkin Lymphoma
- Stage IV Adult Immunoblastic Large Cell Lymphoma
- Stage IV Adult Lymphoblastic Lymphoma
- Stage IV Adult T-cell Leukemia/Lymphoma
- Stage IV Childhood Hodgkin Lymphoma
- Stage IV Chronic Lymphocytic Leukemia
- Accelerated Phase Chronic Myelogenous Leukemia
- Adult Acute Lymphoblastic Leukemia in Remission
- 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 Nasal Type Extranodal NK/T-cell Lymphoma
- Anaplastic Large Cell Lymphoma
- Angioimmunoblastic T-cell Lymphoma
- Childhood Acute Lymphoblastic Leukemia in Remission
- Childhood Acute Myeloid Leukemia in Remission
- Childhood Burkitt Lymphoma
- Childhood Chronic Myelogenous Leukemia
- Childhood Myelodysplastic Syndromes
- Childhood Nasal Type Extranodal NK/T-cell Lymphoma
- Cutaneous B-cell Non-Hodgkin Lymphoma
- de Novo Myelodysplastic Syndromes
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- Hematopoietic/Lymphoid Cancer
- 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 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 T-cell Leukemia/Lymphoma
- Recurrent Childhood Anaplastic Large Cell Lymphoma
- Recurrent Childhood Grade III Lymphomatoid Granulomatosis
- Recurrent Childhood Large Cell Lymphoma
- Recurrent Childhood Lymphoblastic Lymphoma
- Recurrent Childhood Small Noncleaved Cell Lymphoma
- 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
- Recurrent/Refractory Childhood Hodgkin Lymphoma
- Refractory Chronic Lymphocytic Leukemia
- Refractory Multiple Myeloma
- Relapsing Chronic Myelogenous Leukemia
- Secondary Myelodysplastic Syndromes
- Small Intestine Lymphoma
- Splenic Marginal Zone Lymphoma
- Stage II Multiple Myeloma
- Stage III Adult Burkitt Lymphoma
- Stage III Adult Diffuse Large Cell Lymphoma
- Stage III Adult Diffuse Mixed Cell Lymphoma
- Stage III Adult Diffuse Small Cleaved Cell Lymphoma
- Stage III Adult Hodgkin Lymphoma
- Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
- Stage IV Grade 1 Follicular Lymphoma
- Stage IV Grade 2 Follicular Lymphoma
- Stage IV Grade 3 Follicular Lymphoma
- Stage IV Mantle Cell Lymphoma
- Stage IV Marginal Zone Lymphoma
- Stage IV Mycosis Fungoides/Sezary Syndrome
- Stage IV Small Lymphocytic Lymphoma
- Testicular Lymphoma
- Waldenström Macroglobulinemia
Interventions
- DRUG
-
Given IV
- DRUG
-
fludarabine phosphate
Given IV
- DRUG
-
Given IV or orally
- DRUG
-
mycophenolate mofetil
Given orally
- GENETIC
-
polymerase chain reaction
Correlative studies
- GENETIC
-
fluorescence in situ hybridization
Correlative studies
- GENETIC
-
polymorphism analysis
Correlative studies
- GENETIC
-
gene expression analysis
Correlative studies
- RADIATION
-
total-body irradiation
Undergo total-body irradiation
- PROCEDURE
-
allogeneic bone marrow transplantation
Undergo haploidentical hematopoietic bone marrow transplantation
- PROCEDURE
-
allogeneic hematopoietic stem cell transplantation
Undergo haploidentical hematopoietic bone marrow transplantation
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Fred Hutchinson Cancer Center
lead OTHER
Principal Investigators
-
Paul O'Donnell · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-01-31
- Primary Completion
- 2011-03-31
- Completion
- 2014-02-28
Countries
- United States
Study Locations
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