Status:
COMPLETED
Busulfan Plus Clofarabine Followed by Allogeneic Hematopoietic Stem Cell Transplantation
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
Up to 65 years
Phase:
PHASE2
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 advan...
Detailed Description
Study Treatment: Busulfan is designed to bind to DNA (the genetic material of cells), which may cause cancer cells to die. It is commonly used in stem cell transplants. Clofarabine is designed to in...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00990249
Start Date
October 1 2009
End Date
May 1 2016
Last Update
August 7 2018
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030