Clinical trial NCT00871689
Conditions: Leukemia
Keywords: recurrent adult acute myeloid leukemia adult acute myeloid leukemia with 11q23 (MLL) abnormalities 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) recurrent childhood acute myeloid leukemia secondary acute myeloid leukemia childhood acute myeloid leukemia with 11q23 (MLL) abnormalities childhood acute myeloid leukemia with inv(16)(p13;q22) childhood acute myeloid leukemia with t(15;17)(q22;q12) childhood acute myeloid leukemia with t(16;16)(p13;q22) childhood acute myeloid leukemia with t(8;21)(q22;q22)
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2009-01-01; Completion date: 2011-10-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells and natural killer 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. Giving interleukin-2 (IL-2, aldesleukin) after transplant may stimulate the natural killer cells to kill any remaining cancer cells.

PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy together with total-body irradiation followed by interleukin-2 (IL-2, aldesleukin), and umbilical cord blood transplant and to see how well it works in treating patients with relapsed or refractory acute myeloid leukemia.

Detailed description:
OBJECTIVES:

Primary

* To determine the rate of neutrophil engraftment and grade III-IV acute graft-versus-host disease (GVHD) following a T cell depleted (TCD) umbilical cord blood (UCB) transplantation without post-transplant immunosuppression followed by administration of interleukin-2 (IL-2, aldesleukin) (every other day) days +3 to +13 to expand NK cells in vivo.

Secondary

* To evaluate the safety of this regimen as assessed by monitoring the rates of graft failure, acute GVHD, and transplant-related mortality (TRM).
* To perform quantitative, phenotypic, and functional assessments of the in vivo expanded UCB-derived NK cells on (day +72).
* To assess clinical disease response (leukemia clearance and complete remission) and survival duration in these patients.
* To evaluate the tolerability of aldesleukin in these patients.
* To evaluate the tolerance of IL-2

OUTLINE:

* Preparative regimen: Patients receive fludarabine phosphate intravenously (IV) over 1 hour on days -7 to -5 and cyclophosphamide IV on days -7 and -6. Patients undergo total-body irradiation twice daily on days -5 to -2.
* Transplantation: Patients undergo T-cell depleted umbilical cord blood (UCB) transplantation on day 0.
* IL-2 (Aldesleukin) therapy: Patients receive aldesleukin subcutaneously on days +3 6 doses every other day) and +60 (6 doses every other day).

Patients are followed periodically for up to 2 years after transplant.

Arms: arm 1: Patients receive cyclophosphamide, fludarabine phosphate, total-body irradiation, T cell depleted umbilical cord blood transplantation (UCBT), followed by interleukin-2 (IL-2, aldesleukin) every other day beginning day +3 for a total of 6 doses and again on day +60 every other day for 6 doses.
Interventions: intervention 1: aldesleukin intervention 2: cyclophosphamide intervention 3: fludarabine phosphate intervention 4: umbilical cord blood transplantation intervention 5: total-body irradiation
Intervention descriptions: intervention 1: IL-2 will be administered (9 million units; 5 million units if weight is less than 45 kg) every other day beginning on day +3 for a total of 6 doses and again on day +60 every other day for 6 doses. intervention 2: 60 mg/kg over 1 hour intravenously (IV) on days -7 and -6. intervention 3: 25 mg/m\^2 intravenously (IV) over 1 hour on days -7 through -5. intervention 4: On day 0, transplantation will occur with double T-cell depleted (TCD) umbilical cord blood (UCB) units intervention 5: administered on days -5 through -2; 330 cGy daily

Protocol documents: