CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
fludarabine phosphate +5 moredrug
Likely dose
Fludarabine IV, total-body irradiation, followed by cyclosporine PO and mycophenolate mofetil POAI-extracted
Key inclusion· 5
  • ✓De novo AML (FAB M0-M2, M4-M7) or secondary AML achieving CR1 after induction and 1-2 cycles of consolidation chemotherapy
  • ✓Transplant conditioning must occur within 6 months of diagnosis
  • ✓HLA-matched related donor (genotypically or phenotypically identical)
  • ✓Donor age ≥12 years
Key exclusion· 13
  • ✕AML FAB M3 subtype
  • ✕CNS involvement (positive cerebrospinal fluid cytospin at enrollment)
  • ✕Circulating leukemic blasts in peripheral blood
  • ✕HIV seropositivity (patient or donor)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00045435
NCT00045435Phase 2Completed
CompareCT.gov

Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation From HLA Matched Related Donors for Treatment of Older Patients With De Novo or Secondary Acute Myeloid Leukemia in First Complete Remission

Fred Hutchinson Cancer Center·interventional·Posted Jan 27, 2003·Updated Jan 29, 2020

In Brief

A Phase 2 clinical trial evaluating nonmyeloablative allogeneic hematopoietic stem cell transplantation, fludarabine phosphate, and 4 other interventions for Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome and 16 related conditions. Completed, enrolled 17 participants across 2 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), 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 in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Secondary Acute Myeloid Leukemia
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartApr 1, 2002
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 23.4 years ago

Interventions

nonmyeloablative allogeneic hematopoietic stem cell transplantationprocedure

Undergo nonmyeloablative allogeneic PBSC transplant

fludarabine phosphatedrug

Given IV

total-body irradiationradiation

Undergo TBI

cyclosporinedrug

Given PO

mycophenolate mofetildrug

Given PO

peripheral blood stem cell transplantationprocedure

Undergo nonmyeloablative allogeneic PBSC transplant