Clinical trial NCT00619645
Conditions: Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes
Keywords: recurrent adult acute myeloid leukemia adult acute lymphoblastic leukemia in remission refractory anemia with excess blasts refractory anemia with ringed sideroblasts refractory anemia refractory cytopenia with multilineage dysplasia previously treated myelodysplastic syndromes adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia in remission 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) chronic phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia recurrent adult Hodgkin lymphoma refractory multiple myeloma recurrent adult acute lymphoblastic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma secondary acute myeloid leukemia recurrent small lymphocytic lymphoma stage III small lymphocytic lymphoma stage IV small lymphocytic lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma stage III adult diffuse large cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse small cleaved cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma stage III adult immunoblastic large cell lymphoma stage IV adult immunoblastic large cell lymphoma recurrent adult immunoblastic large cell lymphoma stage III adult lymphoblastic lymphoma stage IV adult lymphoblastic lymphoma recurrent adult lymphoblastic lymphoma stage III adult Burkitt lymphoma stage IV adult Burkitt lymphoma recurrent adult Burkitt lymphoma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma de novo myelodysplastic syndromes secondary myelodysplastic syndromes
Sponsor: University of California, Davis
Start date: 2007-06-01; Completion date: 2013-11-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Giving chemotherapy drugs, such as fludarabine and busulfan, before a donor peripheral stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune 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 cyclosporine and mycophenolate mofetil before and after the transplant may stop this from happening.

PURPOSE: This phase II trial is studying the side effects of giving donor peripheral stem cell transplant together with fludarabine and busulfan and to see how well it works in treating patients with hematologic cancers.

Detailed description:
OUTLINE:

* Conditioning regimen: Patients receive busulfan IV over 3 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
* Allogeneic peripheral blood stem cell transplant (PBSC): Patients undergo allogeneic PBSC on day 0.
* Immunosuppressive therapy/graft-versus-host disease (GVHD) prophylaxis: Patients achieve100% donor T-cell chimerism on day 30 without disease recurrence, and cyclosporine A (CSA) IV continuously over 24 hours or orally every 12 hours on days -1 to 60 followed by a taper until day 100 and oral mycophenolate mofetil (MMF) once every 12 hours on days 1-40, in the absence of ≥ grade 2 GVHD.

Patients with recurrent disease or \< 100% donor T-cell chimerism (on day 30) undergo a 12-day CSA and MMF taper followed by escalating doses of previously collected donor leukocyte infusion every 4 weeks until 100% donor T-cell chimerism or disease regression, in the absence of ≥ grade 2 GVHD.

After completion of study treatment, patients are followed periodically.

Arms: arm 1: Busulfan 3.3 mg/kg over 3 hours on day -6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day -6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy
Interventions: intervention 1: busulfan intervention 2: cyclosporine intervention 3: fludarabine phosphate intervention 4: mycophenolate mofetil intervention 5: allogeneic hematopoietic stem cell transplantation intervention 6: peripheral blood stem cell transplantation
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol documents: