NCT00626626|TerminatedPhase 1/2ResultsDMC
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Investigator decision
Sponsor study identifier
interventional
8
1 country
1
Study Start
May 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2010
Actual (reported)Study Completion
January 2010
Actual (reported)Allogeneic hematopoietic transplant is curative for many patients with hematological neoplasms but conditions to provide optimal engraftment and anti-tumor efficacy with minimal toxicity are still under way. Clofarabine is a newly licensed agent with dramatic anti-leukemic activity. Its incorporation into a regimen for pre-transplant conditioning of acute leukemia and lymphoma patients is logical, exploiting both the anti-tumor activities it is recognized to have and the immunosuppressive activity seen with drugs in its class.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2010
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.
May 2007
Date type not reportedThis date has not been verified as actual or estimated.
February 20, 2008
Actual (reported)February 29, 2008
Actual (reported)January 2010
Actual (reported)January 2010
Actual (reported)April 25, 2018
Actual (reported)Engraftment of Allogeneic Blood Cells.
Establish the safety of Clofarabine and cyclophosphamide preceding allogeneic hematopoietic engraftment. Assess the efficacy of Clofarabine and cyclophosphamide as conditioning for promoting allogeneic hematopoietic engraftment. Adequacy of engraftment will be assessed via assessment of chimerism (percent donor engraftment). Less than 20% engraftment by day 30 is then failure of engraftment. Safety is defined per common toxicity criteria - Non-Hematological and non renal toxicities of ≥grade 3 or ≥grade 4 up to day 30 are scored as toxicity.
two years
Disease-Free Survival
Two years
Overall Survival
2 years
Phase 1: 1-3 patients will be treated in order to establish Cyclophosphamide and Clofarabine dose and to confirm reasonable safety and engraftment efficacy. Drug - Clofarabine,Cyclophosphamide \& Alemtuzumab - Clofar (30mg/m2) D -8 to -4; Cyclo (500mg/m2) D -8 \& -7 \& Alem (20mg over 2hrs)
Phase II patients 4-9 will treat at the selected dose level of Clofarabine and Cyclophosphamide. Drug - Clofarabine, Cyclophosphamide \& Alemtuzumab Clofar (30mg/m2) D -8 to -4; Cyclo (1000mg/m2) D -8 \& -7 \& Alem (20mg)-pts.
Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 500 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion.
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Karch J, Zhu J, Ehmann WC, Claxton D. Clofarabine and CY do not yield reliable engraftment of hematopoietic stem cells. Bone Marrow Transplant. 2012 Aug;47(8):1134-5. doi: 10.1038/bmt.2011.224. Epub 2011 Nov 14. No abstract available.
David F Claxton, MD
Penn State College of Medicine
8 participants (actual enrollment reported by the registry).
First Submitted
February 20, 2008
First Posted
February 29, 2008
Study Start
May 2007
Date type not reportedThis date has not been verified as actual or estimated.
Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 1000 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion (patients 4-9)
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Primary Completion
January 2010
Actual (reported)Study Completion
January 2010
Actual (reported)Last Updated
April 25, 2018
Results First Posted
April 25, 2018
Record last verified: 2018-03
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Source: ClinicalTrials.gov.
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