CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 120 enrolled
Drug / intervention
Busulfan +3 moredrug
Likely dose
Busulfan 32 mgfrom 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/NCT00990249
NCT00990249Phase 2Completed

Busulfan Plus Clofarabine Followed by Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Acute Lymphoblastic Leukemia or Lymphoma, or Biphenotypic Leukemia

M.D. Anderson Cancer Center·interventional·Posted Oct 6, 2009·Updated Aug 7, 2018

In Brief

A Phase 2 clinical trial evaluating Busulfan, Clofarabine, and 2 other interventions for Leukemia and 3 related conditions. Completed, enrolled 120 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to test the safety of giving clofarabine in combination with busulfan, followed by an allogeneic (from a donor) stem cell transplant, in patients with advanced leukemia or lymphoma.

Study Details

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

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 6, 2009
Enrollment StartOct 1, 2009
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 16.7 years ago

Interventions

Busulfandrug

Test Dose 32 mg/m\^2 by vein over 45 minutes on Day -8; following doses on Days -6 to -3 derived from pharmacokinetic (PK) testing done up to 11 times over 11 hours after test dose.

Clofarabinedrug

40 mg/m\^2 by vein over 1 hour daily Day -6 through Day -3

Thymoglobulindrug

0.5 mg/kg on Day -3, 1.5 mg/kg on Day -2 and 2.0 mg/kg on Day -1; only patients with HLA nonidentical or unrelated donors

Stem Cell Transplantprocedure

Stem cell infusion on Day 0.