Clinical trial NCT00555048
Conditions: Graft Versus Host Disease Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases
Keywords: graft versus host disease adult acute megakaryoblastic leukemia (M7) adult acute monoblastic leukemia (M5a) adult acute monocytic leukemia (M5b) adult acute myeloblastic leukemia with maturation (M2) adult acute myeloblastic leukemia without maturation (M1) adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myelomonocytic leukemia (M4) adult acute promyelocytic leukemia (M3) adult erythroleukemia (M6a) adult pure erythroid leukemia (M6b) childhood acute megakaryocytic leukemia (M7) childhood acute monoblastic leukemia (M5a) childhood acute monocytic leukemia (M5b) childhood acute myeloblastic leukemia with maturation (M2) childhood acute myeloblastic leukemia without maturation (M1) childhood acute myelomonocytic leukemia (M4) childhood acute promyelocytic leukemia (M3) accelerated phase chronic myelogenous leukemia adult acute lymphoblastic leukemia in remission 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) blastic phase chronic myelogenous leukemia childhood acute lymphoblastic leukemia in remission childhood acute myeloid leukemia in remission childhood chronic myelogenous leukemia chronic phase chronic myelogenous leukemia recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia relapsing chronic myelogenous leukemia secondary acute myeloid leukemia childhood myelodysplastic syndromes de novo myelodysplastic syndromes myelodysplastic/myeloproliferative diseases secondary myelodysplastic syndromes
Sponsor: Fred Hutchinson Cancer Center
Start date: 2007-09-01; Completion date: 2010-10-01
Enrollment: 1 participants; Allocation: ; Intervention model: 

Brief summary:
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Giving chemotherapy drugs, such as busulfan and cyclophosphamide, before a donor stem cell transplant helps stop the growth of cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving tacrolimus and methotrexate after the transplant may stop this from happening.

PURPOSE: This phase I/II trial is studying the best dose of alemtuzumab when given together with busulfan and cyclophosphamide followed by a donor stem cell transplant and to see how well it works in treating patients with hematologic cancer.

Detailed description:
OBJECTIVES:

Primary

* Identify the lowest dose of alemtuzumab that is associated with day 180 transplant-related mortality ≤ 45%.

Secondary

* Determine the incidence of life-threatening infection in patients receiving this treatment.
* Determine the incidence of grades III-IV acute graft-vs-host disease (GVHD) in patients receiving this treatment.
* Determine the survival at 1 year in patients receiving this treatment.
* Determine the incidence of disease relapse at 1 year in patients receiving this treatment.
* Determine the incidence of extensive chronic GVHD at 1 year in patients receiving this treatment.
* Determine the incidence of graft failure at day 100 in patients receiving this treatment.

OUTLINE:

* Chemotherapy: Patients receive alemtuzumab IV over 2 hours on days -10 to -6, busulfan IV over 3 hours on days -7 to -4, and cyclophosphamide IV on days -3 and -2.
* Peripheral blood stem cell (PBSC) transplantation: Patients undergo allogeneic filgrastim (G-CSF)-mobilized PBSC transplantation on day 0.
* Graft-vs-host disease prophylaxis: Patients receive tacrolimus IV continuously or orally twice daily on days -1 to 50 and methotrexate IV on days 1, 3, 6, and 11.

After completion of study therapy, patients are followed periodically.

Arms: arm 1: Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.
Interventions: intervention 1: alemtuzumab intervention 2: busulfan intervention 3: cyclophosphamide intervention 4: methotrexate intervention 5: tacrolimus intervention 6: allogeneic hematopoietic stem cell transplantation intervention 7: 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 intervention 7: None

Protocol documents: