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
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|ClinicalTrials.gov Identifier: NCT01008462|
Recruitment Status : Completed
First Posted : November 5, 2009
Results First Posted : May 29, 2019
Last Update Posted : June 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|B-Cell Prolymphocytic Leukemia Hypodiploidy Loss of Chromosome 17p Plasma Cell Leukemia Progression of Multiple Myeloma or 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(14;16) t(4;14) T-Cell Prolymphocytic Leukemia Waldenstrom Macroglobulinemia||Procedure: Allogeneic Bone Marrow Transplantation Procedure: Allogeneic Hematopoietic Stem Cell Transplantation Procedure: Autologous Hematopoietic Stem Cell Transplantation Procedure: Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation Drug: Carmustine Drug: Cyclophosphamide Drug: Cytarabine Drug: Etoposide Drug: Fludarabine Phosphate Other: Laboratory Biomarker Analysis Drug: Melphalan Drug: Mycophenolate Mofetil Procedure: Peripheral Blood Stem Cell Transplantation Drug: Tacrolimus Radiation: Total-Body Irradiation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 18, 2010|
|Actual Primary Completion Date :||June 30, 2018|
|Actual Study Completion Date :||June 30, 2018|
Experimental: Treatment (autologous HCT, donor HCT)
See Detailed Description
Procedure: Allogeneic Bone Marrow Transplantation
Undergo donor HCT
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Undergo donor HCT
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Undergo autologous PBSC transplant
Procedure: Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation
Undergo autologous-donor tandem HCT
Other Name: auto-allo HCT
Drug: Fludarabine Phosphate
Other: Laboratory Biomarker Analysis
Drug: Mycophenolate Mofetil
Procedure: Peripheral Blood Stem Cell Transplantation
Undergo donor HCT
Given IV or PO
Radiation: Total-Body Irradiation
- Event-Free Survival (EFS) [ Time Frame: 1 Year post-autograft ]Number of patients surviving without relapsed/progressive disease
- Number of Patients With Relapsed/Progressive Disease [ Time Frame: 1 year post-autograft ]
Relapse/Progression defined as:
Nodes, liver, and/or spleen ≥50% increased or new by physical exam / imaging studies.
Circulating lymphocytes ≥50% increased by morphology and/or flow cytometry. Richter's transformation by lymph node biopsy .
- Overall Survival [ Time Frame: 1 year post-autograft ]Number of patients surviving one year post-autograft
- Number of Patients With Grade II-IV Acute Graft-versus-Host-Disease and/or Chronic Extensive Graft-versus-Host-Disease [ Time Frame: 1 year post-allograft, ]
aGVHD The diagnosis of aGVHD is identified through various stages and grading of the disease related to Skin (Rash), Gut (Diarrhea, Nausea/vomiting and/or anorexia) and the liver (Bilirubin) assessed by severity and grading scale outlined in the section Grafts vs Hosts by Sullivan (1999).
GVHD Grades Grade I: 1-2 Skin Rash; No gut or liver involvement Grade II: Stage 1-3 Skin rash; Stage 1 gut and/or stage 1 liver involvement Grade III: Stage 2-4 gut involvement and/or stage 2-4 liver involvement with or without rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death
CGVHD The diagnosis of cGVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.
- Non-relapse Mortality (NRM) [ Time Frame: 200 days and 1 Year post-allograft ]Number of patients with non-relapse mortalities.
- Number of Patients Who Engrafted [ Time Frame: Day 84 post-allograft ]Number of patients with donor engraftment.
- Number of Patients Who Had Infections [ Time Frame: 1 Year post-autograft ]Number of patients who had infections.
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): NCT01008462
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|United States, Wisconsin|
|Froedtert and the Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Mohamed Sorror||Fred Hutch/University of Washington Cancer Consortium|