Autologous Peripheral Blood Stem Cell Transplant Followed by Donor Bone Marrow Transplant in Treating Patients With High-Risk Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia
This study was designed to combine two types of stem cell transplant. The first would be the use of high-dose chemotherapy and autologous stem cell transplantation (using your own stem cells). This type of stem cell transplant has the advantage of no graft-versus-host disease (GVHD) and very low risk of death, while minimizing the number of cancer cells. Then, the investigators will wait for a period between 40-120 days to allow your body to recover from the high-dose chemotherapy. Then, you will receive the second type of transplant "nonmyeloablative transplant" from your haploidentical family donor. The investigators hope that the donor cells will then eliminate any remaining tumor cells.
The investigators are doing this study:
- To see if the combined stem cell transplant will help prevent the blood or lymph nodes' cancer from coming back.
- To see if the combined stem cell transplant will be safe with no increased toxicities or deaths compared to "nonmyeloablative transplant" alone.
Peripheral blood stem cell (PBSC) transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. These donated stem cells may help destroy cancer cells (graft-versus-tumor effect).
B-Cell Prolymphocytic Leukemia
Plasma Cell Leukemia
Recurrent Adult Hodgkin Lymphoma
Recurrent Adult Non-Hodgkin Lymphoma
Recurrent Childhood Hodgkin Lymphoma
Recurrent Childhood Non-Hodgkin Lymphoma
Recurrent Chronic Lymphocytic Leukemia
Recurrent Plasma Cell Myeloma
Recurrent Small Lymphocytic Lymphoma
Refractory Childhood Hodgkin Lymphoma
Refractory Chronic Lymphocytic Leukemia
Refractory Non-Hodgkin Lymphoma
Refractory Plasma Cell Myeloma
Refractory Small Lymphocytic Lymphoma
T-Cell Prolymphocytic Leukemia
Drug: Fludarabine Phosphate
Drug: Mycophenolate Mofetil
Radiation: Total-Body Irradiation
Procedure: Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Procedure: Allogeneic Bone Marrow Transplantation
Other: Laboratory Biomarker Analysis
Procedure: Peripheral Blood Stem Cell Transplantation
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Sequential Autologous HCT / Nonmyeloablative Allogeneic HCT Using Related, HLA-Haploidentical Donors for Patients With High-Risk Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia|
- Progression-free survival (PFS) [ Time Frame: Calculated for all patients from the date of autologous transplant until the time of death, assessed up to 1 year ] [ Designated as safety issue: No ]An observed 1-year PFS of >= 50% would be considered efficacious and worthy of further study.
- Rates of relapse, defined by presence of malignant cells in marrow, peripheral blood or extramedullary sites detectable by morphologic, flow cytometric, cytogenetic or molecular assays not evident at the time of transplant [ Time Frame: At 1 year ] [ Designated as safety issue: No ]Summarized using cumulative incidence estimates. Confidence intervals will be also be estimated.
- Early non-relapse mortality (NRM) [ Time Frame: At 200 days ] [ Designated as safety issue: No ]Recorded and reported on clinical reporting forms (CRFs). Every effort will be made to determine the exact cause of death for all patients as they occur. Reasonable evidence will be taken to mean that the lower bound of a one-sided 80% confidence interval for the true rate of NRM is above 0.30.
- Incidence/severity of acute and chronic GVHD [ Time Frame: Up to 84 days ] [ Designated as safety issue: No ]Skin involvement should be assessed by punch biopsy. The percentage of body surface area involved will be recorded. Gastrointestinal symptoms suspicious for GVHD should be evaluated by endoscopy and biopsy as indicated. Time to onset of GVHD will be recorded.
- Immune reconstitution after allografting [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
- Reconstitution of lymphocyte subsets in peripheral blood [ Time Frame: Up to 84 days ] [ Designated as safety issue: No ]Absolute counts of B-cells (CD19+), T-cell subsets (determined by differential expression of CD4, CD8 or CD45 isoforms on CD3+ cells) and natural killer cells (CD16+/CD56+) in peripheral blood should be compared to pre-transplant lymphocyte.
- Overall survival [ Time Frame: At 1 year ] [ Designated as safety issue: No ]Estimated by the method of Kaplan and Meier. Confidence intervals will be also be estimated.
- Incidence of engraftment failure or rejection [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
- Incidence of infections [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2010|
|Estimated Primary Completion Date:||January 2020 (Final data collection date for primary outcome measure)|
Experimental: Treatment (autologous HCT/nonmyeloablative donor HCT)
See Detailed Description
Other Name: FDA 0345Drug: Etoposide
Other Name: LastetDrug: Cytarabine
Other Names:Drug: Fludarabine Phosphate
Other Names:Drug: Cyclophosphamide
Given IVDrug: Tacrolimus
Given IV or PO
Other Names:Drug: Mycophenolate Mofetil
Other Names:Radiation: Total-Body Irradiation
Other Names:Drug: Melphalan
Other Name: AlkeranProcedure: Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation
Undergo autologous-donor tandem HCT
Other Name: auto-allo HCTProcedure: Autologous Hematopoietic Stem Cell Transplantation
Undergo autologous PBSC transplant
Other Name: Autologous Stem Cell TransplantationProcedure: Allogeneic Bone Marrow Transplantation
Undergo donor HCT
Other Names:Other: Laboratory Biomarker Analysis
Correlative studyProcedure: Peripheral Blood Stem Cell Transplantation
Undergo donor HCT
Other Names:Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Undergo donor HCT
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01008462
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Mohamed L. Sorror 206-667-2765|
|Principal Investigator: Mohamed L. Sorror|
|United States, Wisconsin|
|Froedtert and the Medical College of Wisconsin||Completed|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Mohamed Sorror||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|