Phase 2
Completed N=60
Clofarabine and Temsirolimus in Treating Older Patients With Relapsed or Refractory Acute Myeloid Leukemia
Source: ClinicalTrials.gov NCT00775593 ↗Enrolled (actual)
60
Serious AEs
28.3%
Results posted
Mar 2015
Primary outcomePrimary: Complete Response Rate — 4 participants
Summary
RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving clofarabine together with temsirolimus may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving clofarabine together with temsirolimus works in treating older patients with relapsed or refractory acute myeloid leukemia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response Rate |
4 | — |
| SECONDARY Number of Serious Adverse Events Within 2 Years |
22 | — |
| SECONDARY Duration of Response |
3.5 | — |
| SECONDARY Duration of Survival |
10.9 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Cytologically confirmed acute myeloid leukemia (AML) meeting the following criteria:
- At least 20% of blasts in the bone marrow
- AML in first relapse OR refractory to no more than one prior combination of intensive chemotherapy induction regimen
- No acute promyelocytic leukemia
- No blast transformation of chronic myeloid leukemia or other myeloproliferative disorders
- No active CNS leukemia
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Life expectancy ≥ 4 weeks
- Serum total bilirubin ≤ 1.5 times upper limit of normal (ULN)*
- AST and ALT ≤ 2.5 times ULN*
- Serum creatinine ≤ 1.0 mg/dL* OR estimated glomerular filtration rate > 60 mL/min
- No active uncontrolled systemic infection
- No concurrent active malignancy
- No HIV positivity
- No severe concurrent medical condition or psychiatric disorder that would preclude study participation NOTE: *Unless due to organ leukemic involvement
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 2 weeks since prior myelosuppressive chemotherapy
- At least 48 hours since prior hydroxyurea
- No prior clofarabine or temsirolimus
- No prior allogeneic stem cell transplantation
- No investigational drug within the past 30 days
Data sourced from ClinicalTrials.gov (NCT00775593). 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.