CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
decitabine +9 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01707004
NCT01707004Phase 2Completed
CompareCT.gov

Decitabine Followed by Bone Marrow Transplant and High-Dose Cyclophosphamide for the Treatment of Relapsed and Refractory Acute Myeloid Neoplasms

University of Wisconsin, Madison·interventional·Posted Oct 15, 2012·Updated Nov 21, 2019

In Brief

A Phase 2 clinical trial evaluating decitabine, fludarabine phosphate, and 8 other interventions for Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome and 11 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This phase II trial studies how well decitabine and total-body irradiation followed by donor bone marrow transplant and cyclophosphamide works in treating patients with relapsed or refractory acute myeloid leukemia. Giving decitabine and total-body irradiation before a donor bone marrow 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 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 decitabine and total-body irradiation before the transplant together with high-dose cyclophosphamide, tacrolimus, 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 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(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 15, 2012
Enrollment StartMay 16, 2013
Primary CompletionJul 22, 2017
Study CompletionOct 7, 2017
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 13.7 years ago

Interventions

decitabinedrug

Given IV

fludarabine phosphatedrug

Given IV

busulfandrug

Given IV

cyclophosphamidedrug

Given IV

tacrolimusdrug

Given PO or IV

mycophenolate mofetildrug

Given PO

filgrastimbiological

Given SC

total-body irradiationradiation

Undergo total-body irradiation

allogeneic bone marrow transplantationprocedure

Undergo allogeneic bone marrow transplantation

laboratory biomarker analysisother

Correlative studies