Phase 2
N=116
Clofarabine Combinations in Relapsed/Refractory Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS) and Myeloid Blast Phase Chronic Myeloid Leukemia (CML)
Acute Myeloid Leukemia · Myelodysplastic Syndrome · Chronic Myeloid Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00067028 ↗Enrolled (actual)
116
Serious AEs
25.9%
Results posted
Dec 2020
Primary outcome: Primary: Participants With a Response — 4; 9; 16; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Clofarabine 40mg/m^2 (Drug); Idarubicin 10mg/m^2 (Drug); Ara-C 0.75 g/m^2 (Drug); Clofarabine 22.5mg/m^2 (Drug); Ara-C 1 g/m^2 (Drug); Idarubicin 6 mg/m^2 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With a Response |
4; 9; 16; 2; 5; 7 | — |
| SECONDARY Overall Response Rate (ORR) |
36; 44; 24 | — |
Summary
The goal is to compare the drug combinations clofarabine/idarubicin/ara-C, clofarabine/ara-C, and clofarabine/idarubicin in the treatment of patients with Acute Myeloid Leukemia, high-grade MDS, or myeloid blast phase of Chronic Myeloid Leukemia who have relapsed following their initial therapy.
Eligibility Criteria
Inclusion Criteria
- Age >/= 18 years and /= 10% blasts) with not more than one prior regimen of chemotherapy (therapy with hematopoietic growth factors, biological or targeted therapies are not counted). Patients in CML myeloid blast phase may receive clofarabine as frontline therapy or in first salvage.
- Total bilirubin = 1 year postmenopausal or surgically sterilized).
Exclusion Criteria
- Previous treatment with clofarabine.
- Active, uncontrolled, systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment, or any severe, concurrent disease, which, in the judgment of the investigator and after discussion with the Principal Investigator, would make the patient inappropriate for study entry.
- Symptomatic central nervous system (CNS) involvement.
- Patients who receive other chemotherapy. Patients must have been off previous therapy of >/= 2 weeks and must have recovered from acute toxicity of all previous therapy prior to enrollment. Treatment may start earlier following discussion with the Principal Investigator.
- Cardiac ejection fraction </= 30%.
Data sourced from ClinicalTrials.gov (NCT00067028). 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.