Phase 2
Completed N=17
Reduced Intensity Donor Peripheral Blood Stem Cell Transplant in Treating Patients With De Novo or Secondary Acute Myeloid Leukemia in Remission
Source: ClinicalTrials.gov NCT00045435 ↗Enrolled (actual)
17
Serious AEs
29.4%
Results posted
Mar 2017
Primary outcomePrimary: Disease-free Survival-incidence of Survival Without Relapse — 47 percentage of participants
Summary
This phase II trial studies how well reduced intensity donor peripheral blood stem cell (PBSC) transplant works in treating patients with de novo or secondary acute myeloid leukemia (AML) in remission. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body irradiation (TBI) before a donor PBSC transplant helps stop the growth of cancer cells. It may also stop 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 after the transplant may stop this from happening
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease-free Survival-incidence of Survival Without Relapse |
47 | — |
| PRIMARY Nonrelapse Mortality (NRM)-Incidence of Nonrelapse Death |
6 | — |
| SECONDARY Overall Survival |
70.6 | — |
| SECONDARY Incidence of Relapse |
41.2 | — |
| SECONDARY Incidence of Rejection |
— | — |
| SECONDARY Incidence of Acute and Chronic GVHD |
35.3; 35.3 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with de novo AML (French-American-British [FAB] MO-M2, M4-M7) or secondary AML who achieve CR1 after induction chemotherapy and one or two cycles of consolidation chemotherapy
- Transplant conditioning must occur within 6 months of diagnosis
- Patient enrollment must be approved by the Fred Hutchinson Cancer Research Center (FHCRC) principal investigator (PI) or the PI's designee
- DONOR: Related donor who is genotypically or phenotypically identical
- DONOR: Age >= 12 years
- DONOR: Donor must consent to filgrastim (G-CSF) administration and leukapheresis
- DONOR: Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian)
Exclusion Criteria
- AML FAB M3
- AML involvement of the central nervous system (CNS) as defined by a positive cytospin of cerebral spinal fluid at the time of enrollment
- Presence of circulating leukemic blasts (in the peripheral blood) detected by standard pathology
- Human immunodeficiency virus (HIV) seropositivity
- Fungal infections with radiographic progression after receipt of amphotericin B or active triazole for greater than one month
- Diffusion capacity of carbon monoxide (DLCO) corrected 3mg/dL, or symptomatic biliary disease
- Karnofsky Performance Score 20% risk of disease recurrence
- Patients with active bacterial or fungal infections unresponsive to medical therapy
- DONOR: Identical twin
- DONOR: Pregnancy
- DONOR: HIV seropositivity
- DONOR: Inability to achieve adequate venous access
- DONOR: Known allergy to G-CSF
- DONOR: Current serious systemic illness
Data sourced from ClinicalTrials.gov (NCT00045435). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.