Busulfan Plus Clofarabine Followed by Allogeneic Hematopoietic Stem Cell Transplantation
2 other identifiers
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 leukemia
Started Oct 2009
Typical duration for phase_2 leukemia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 2, 2009
CompletedFirst Posted
Study publicly available on registry
October 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedResults Posted
Study results publicly available
August 7, 2018
CompletedAugust 7, 2018
May 1, 2017
6.6 years
October 2, 2009
May 26, 2017
July 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment-Related Mortality (TRM) Defined as Non Relapse Mortality (NRM)
NRM was defined as death from any cause other than disease progression or relapse and reported as percentage of participant deaths. Treatment related deaths after transplant are defined either by deaths which could not be attributed to disease relapse or progression or by deaths without previous relapse or progression. For TRM at day 100, Bayesian method of Thall, Simon, and Estey used to perform interim monitoring.
100 Days
Study Arms (1)
Busulfan + Clofarabine + Stem Cell Transplant
EXPERIMENTALBusulfan 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. Clofarabine 40 mg/m\^2 by vein over 1 hour daily Day -6 through Day -3. Thymoglobulin 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 infusion on Day 0.
Interventions
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.
40 mg/m\^2 by vein over 1 hour daily Day -6 through Day -3
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 infusion on Day 0.
Eligibility Criteria
You may qualify if:
- Patients with biopsy-proven acute lymphoblastic leukemia, acute lymphoblastic lymphoma, or acute biphenotypic leukemia in remission or relapse.
- Adequate renal function, as defined by estimated serum creatinine clearance \>60 ml/min.
- Bilirubin equal or less than 1.5 (unless Gilbert's Syndrome), serum glutamate pyruvate transaminase (SGPT) \<3 X upper limit of normal and alkaline phosphatase \<2 X upper limit of normal.
- Adequate pulmonary function with forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusion capacity of lung for carbon monoxide (DLCO) at least 45% of expected corrected for hemoglobin. Children unable to perform pulmonary functions must have an oxygen saturation greater than 92% at room air.
- Adequate cardiac function with left ventricular ejection fraction at least 45% on appropriate medical therapy. No uncontrolled arrhythmias or symptomatic cardiac disease.
- Zubrod performance status \<2 or Lansky/Karnofsky PS equal or greater to 70%.
- Patients must have a related, genotypically HLA identical donor, or they must have a unrelated donor who is 8/8 HLA match by high resolution typing.
- Patient or patient's legal representative, parent(s) or guardian should provide written informed consent. Assent of a minor if participant's age is at least seven and less than eighteen years.
- Negative Beta Human Chorionic Gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months and no previous surgical sterilization.
You may not qualify if:
- Patients with unresolved grade \>2 non-hematologic toxicity from previous therapy. Patients with grade 2 toxicity will be eligible at the discretion of the PI.
- Patients with active central nervous system (CNS) disease.
- Evidence of acute or chronic active hepatitis or cirrhosis.
- Uncontrolled infection, including HIV, HTLV-1, hepatitis B or hepatitis C viremia.
- Patients greater than 65 years-old.
- Prior autologous or allogeneic hematopoietic stem cell transplant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Partow Kebriaei, MD/Professor, Stem Cell Transplantation
- Organization
- The University of Texas (UT) MD Anderson Cancer Center
Study Officials
- STUDY CHAIR
Partow Kebriaei, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2009
First Posted
October 6, 2009
Study Start
October 1, 2009
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
August 7, 2018
Results First Posted
August 7, 2018
Record last verified: 2017-05