Phase 2
Completed N=120
Busulfan Plus Clofarabine Followed by Allogeneic Hematopoietic Stem Cell Transplantation
leukemia · Lymphoma · Allogeneic Haematopoietic Stem Cell Transplantation · Acute Lymphoblastic Leukemia
Source: ClinicalTrials.gov NCT00990249 ↗
Enrolled (actual)
120
Serious AEs
2.5%
Results posted
Aug 2018
Primary outcomePrimary: Treatment-Related Mortality (TRM) Defined as Non Relapse Mortality (NRM) — 10 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment-Related Mortality (TRM) Defined as Non Relapse Mortality (NRM) |
10 | — |
Eligibility Criteria
Inclusion Criteria
- 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) 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.
Data sourced from ClinicalTrials.gov (NCT00990249). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.