Recurrent Small Lymphocytic Lymphoma Clinical Trial
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
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.
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.
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