NCT01471444|CompletedPhase 3ResultsDMCFDA Drug
Loading search results
A Randomized Study of Once Daily Fludarabine-Clofarabine Versus Fludarabine Alone Combined With Intervenous Busulfan Followed by Allogeneic Hemopoietic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
Sponsor study identifier
Secondary identifiers
REGISTRY · NCI CTRP
interventional
256
1 country
1
Study Start
November 2, 2011
Actual (reported)Primary Completion
December 14, 2020
Actual (reported)Study Completion
December 14, 2020
Actual (reported)The goal of this clinical research study is to learn if combining busulfan with clofarabine and fludarabine can help control the disease better than the previous standard method (using busulfan and fludarabine alone) in patients with AML or MDS. The safety of this combination therapy will also be studied.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 14, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2, 2011
Actual (reported)November 10, 2011
Actual (reported)November 15, 2011
Actual (reported)December 14, 2020
Actual (reported)December 14, 2020
Actual (reported)December 16, 2021
Actual (reported)Progression-Free Survival (PFS)
Number of events with progression free survival. (Progression is defined as more than 5% blast in the peripheral blood or bone marrow biopsy.) or expired from treatment related mortality post transplant.
From day of transplant to disease of progression or death of any cause, whichever came first, assessed up to 5 years
Overall Survival (OS) Post Transplant at 1, 3 and 5 Years
Post transplant after 1, 3 and 5 years
Number of Participants in the Study Who Are With no Grade 3 or 4 Acute Graft-versus-host Disease at Any Time During the First 100 Days Post Transplant.
100 days post transplant
Fludarabine 40 mg/m2 intravenous (IV) over 1 hour. Busulfan dose calculated to achieve a systemic exposure dose of 6000 µMol-min IV over 3 hours every 24 hours. Both delivered for 4 consecutive days (days -6 to -3). Stem cell transplant Day 0.
Fludarabine 10 mg/m2 over 1 hour. Clofarabine 40 mg/m2 diluted in normal saline to produce a final concentration of 0.4 mg/mL, infused over 1 hour. Busulfan dose calculated to achieve a systemic exposure dose of 6000 µMol-min IV over 3 hours every 24 hours, immediately after Clofarabine. All delivered on 4 consecutive days (days -6 through -3). Stem cell transplant Day 0.
Flu + Bu Group: 40 mg/m2 by vein on Days -6 through -3. Flu +Clo + Bu Group: 10 mg/m2 by vein on Days -6 through -3.
30 mg/m2 diluted in normal saline to produce a final concentration of 0.4 mg/mL, and infused on Days -6 through -3.
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Richard E. Champlin, BS,MD
M.D. Anderson Cancer Center
256 participants (actual enrollment reported by the registry).
First Submitted
November 10, 2011
First Posted
November 15, 2011
Study Start
November 2, 2011
Actual (reported)Number of Participants With Non Relapse Mortality at 100 Day Post Transplant
100 day Post Transplant
Busulfan systemic exposure dose of 6000 µMol-min in normal saline over three (3) hours by vein every twenty-four (24) hours for four (4) consecutive days (days -6 to -3), starting immediately after the completion of Clofarabine. The dose on day -6 to -3 based on pharmacokinetic analysis of target AUC of 4,000 µMol-min ± 5% for 61-70 years of age (without Pharmacokinetics alternate dose 130 mg/m2).
Both groups who receive a graft from an unrelated donor: 0.5 mg/kg on day -3, 1.5 mg/kg on day -2 and 2.0 mg/kg on day -1. On day -3, administered after the chemotherapy is complete.
Cryopreserved bone marrow or peripheral blood progenitor cells infused on day 0.
Starting dose: 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Changed to oral dosing when tolerated and can be tapered off after day +90 if no graft versus host disease (GVHD) present.
5 mg/m2 by vein on Days 1, 3, 6 and 11 post transplant.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 14, 2020
Actual (reported)Study Completion
December 14, 2020
Actual (reported)Last Updated
December 16, 2021
Results First Posted
December 16, 2021
Record last verified: 2021-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: