CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
Clofarabine +7 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/NCT01252667
NCT01252667Phase 2Completed

A Phase II Study of Optimally Dosed Clofarabine in Combination With Low-Dose TBI to Decrease Relapse Rates After Related or Unrelated Donor Hematopoietic Cell Transplantation in Patients With AML

Fred Hutchinson Cancer Center·interventional·Posted Dec 3, 2010·Updated Apr 16, 2020

In Brief

A Phase 2 clinical trial evaluating Allogeneic Hematopoietic Stem Cell Transplantation, Clofarabine, and 6 other interventions for Acute Myeloid Leukemia. Completed, enrolled 44 participants across 4 sites.

Detailed Summary

This phase II trial studies the side effects and how well clofarabine works when given together with low-dose total-body irradiation (TBI) in treating patients with acute myeloid leukemia (AML) undergoing donor peripheral blood stem cell transplant (PBSCT). Giving chemotherapy and TBI before a donor PBSCT 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 3, 2010
Enrollment StartJan 25, 2011
Primary CompletionJan 25, 2019
Study CompletionMar 1, 2019
TodayJul 2, 2026
Enrollment to primary: 8 yearsPosted 15.6 years ago

Interventions

Allogeneic Hematopoietic Stem Cell Transplantationprocedure

Undergo allogeneic hematopoietic PBSCT

Clofarabinedrug

Given IV

Cyclosporinedrug

Given PO

Laboratory Biomarker Analysisother

Correlative studies

Mycophenolate Mofetildrug

Given PO

Peripheral Blood Stem Cell Transplantationprocedure

Undergo allogeneic hematopoietic PBSCT

Pharmacological Studyother

Optional correlative studies

Total-Body Irradiationradiation

Undergo TBI