Clinical Trials Directory

Trials / Completed

CompletedNCT01008462

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

Sequential Autologous HCT / Nonmyeloablative Allogeneic HCT Using Related, HLA-Haploidentical Donors for Patients With High-Risk Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
16 (actual)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
75 Years
Healthy volunteers
Not accepted

Summary

This phase II trial studies 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. Autologous stem cell transplantation uses the patient's stem cells and does not cause graft versus host disease (GVHD) and has a very low risk of death, while minimizing the number of cancer cells. Peripheral blood stem cell (PBSC) transplant uses stem cells from the patient or a donor and may be able to replace immune cells that were destroyed by chemotherapy. These donated stem cells may help destroy cancer cells. Bone marrow transplant known as a nonmyeloablative transplant uses stem cells from a haploidentical family donor. Autologous peripheral blood stem cell transplant followed by donor bone marrow transplant may work better in treating patients with high-risk Hodgkin lymphoma, non-Hodgkin lymphoma, multiple myeloma, or chronic lymphocytic leukemia.

Detailed description

PRIMARY OBJECTIVES: I. Event-free survival (EFS) at 1-year after autograft. SECONDARY OBJECTIVES: I. Relapse rates at 1-year after autograft. II. Overall survival (OS) at 1-year after autograft. III. Incidence of grades II-IV acute GVHD and chronic extensive GVHD. IV. Non-relapse mortality (NRM) at 200 days and 1 year after allograft. V. Donor engraftment at day +84. VI. Incidence of infections. OUTLINE: CONDITIONING REGIMEN 1 (lymphoma, Waldenstrom macroglobulinemia, or chronic lymphocytic leukemia \[CLL\] with no dose limiting radiation or significant comorbidities: Patients receive cyclophosphamide intravenously (IV) on days -6 and -5. Patients undergo high-dose total body irradiation (TBI) twice daily (BID) on days -3 to -1. CONDITIONING REGIMEN 2 (lymphoma, Waldenstrom Macroglobulinemia, CLL, with prior dose-limiting radiation, or significant comorbidities): Patients receive carmustine IV on day -7, etoposide IV BID on days -6 to -3, cytarabine IV BID on days -6 to -3, and melphalan IV on day -2. CONDITIONING REGIMEN 3 (multiple myeloma or plasma cell leukemia, with no significant renal insufficiency or other significant comorbidities): Patients receive high-dose melphalan IV on day -2. CONDITIONING REGIMEN 4 (multiple myeloma or plasma cell leukemia, with significant renal insufficiency or other significant comorbidities): Patients receive lessened dose of melphalan IV on day -2. PBSC TRANSPLANTATION: All patients undergo autologous PBSC transplantation on day 0. WAITING INTERVAL: Between 40 and 120 days. NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV once daily (QD) on days -6 to -2 and cyclophosphamide IV QD on days -6 to -5 and day 3. Patients infused with donor's peripheral blood stem cells will additionally receive cyclophosphamide IV on day 4. Patients undergo low-dose TBI on day -1. ALLOGENEIC BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0. GRAFT VERSUS HOST DISEASE PROPHYLAXIS: Beginning on day 4, patients receive tacrolimus orally (PO) or IV and taper beginning on day 86 if no graft-versus-host disease. Patients also receive mycophenolate mofetil PO thrice daily (TID) on days 4 - 35. PERIPHERAL BLOOD COUNT SUPPORT: Patients receive filgrastim (G-CSF) IV or subcutaneously (SC) beginning from day 4 and continue till blood counts recover. ALLOGENEIC PERIPHERAL BLOOD MONONUCLEAR CELLS (PBMC) TRANSPLANTATION: Patients undergo donor PBMC transplantation on day 0. GRAFT VERSUS HOST DISEASE PROPHYLAXIS: Beginning on day 5, patients receive tacrolimus orally (PO) or IV and taper beginning on day 86 if no graft-versus-host disease. Patients also receive mycophenolate mofetil PO thrice daily (TID) on days 5 - 35. PERIPHERAL BLOOD COUNT SUPPORT: Patients receive filgrastim IV or SC beginning from day 5 and continue till blood counts recover. After completion of study treatment, patients are followed up annually for 5 years.

Conditions

Interventions

TypeNameDescription
PROCEDUREAllogeneic Bone Marrow TransplantationUndergo donor HCT
PROCEDUREAllogeneic Hematopoietic Stem Cell TransplantationUndergo donor HCT
PROCEDUREAutologous Hematopoietic Stem Cell TransplantationUndergo autologous PBSC transplant
PROCEDUREAutologous-Allogeneic Tandem Hematopoietic Stem Cell TransplantationUndergo autologous-donor tandem HCT
DRUGCarmustineGiven IV
DRUGCyclophosphamideGiven IV
DRUGCytarabineGiven IV
DRUGEtoposideGiven IV
DRUGFludarabine PhosphateGiven IV
OTHERLaboratory Biomarker AnalysisCorrelative study
DRUGMelphalanGiven IV
DRUGMycophenolate MofetilGiven PO
PROCEDUREPeripheral Blood Stem Cell TransplantationUndergo donor HCT
DRUGTacrolimusGiven IV or PO
RADIATIONTotal-Body IrradiationUndergo TBI

Timeline

Start date
2010-03-18
Primary completion
2018-06-30
Completion
2018-06-30
First posted
2009-11-05
Last updated
2019-06-11
Results posted
2019-05-29

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01008462. Inclusion in this directory is not an endorsement.