Phase 2
N=39
A Phase II Open-Label Study of High-Dose Cytarabine and Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia or Refractory or Relapsed Acute Lymphoblastic Leukemia
Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT01656031 ↗Enrolled (actual)
39
Serious AEs
100.0%
Results posted
Feb 2013
Primary outcome: Primary: Measure Patient Response to High-dose Cytarabine Followed by Clofarabine in Adult Patients With Relapsed or Refractory AML — 17 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- clofarabine (Drug); cytarabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measure Patient Response to High-dose Cytarabine Followed by Clofarabine in Adult Patients With Relapsed or Refractory AML |
17 | — |
Summary
RATIONALE: Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying clofarabine when given together with cytarabine to see how well they work in treating patients with refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Pathologic confirmation of acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL)
- No M3 AML
- Meets 1 of the following criteria:
- In first relapse
- In second relapse after a second complete remission (CR) that lasted ≥ 3 months
- Refractory to initial induction therapy
- No symptomatic CNS involvement
PATIENT CHARACTERISTICS:
- ECOG performance status ≤ 2
- Creatinine < 2 mg/dL
- Bilirubin ≤ 2 mg/dL
- AST and ALT ≤ 4 times upper limit of normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 weeks after completing study treatment
- Ejection fraction ≥ 45% by echocardiogram
- No active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant
- No psychiatric disorders that would interfere with giving consent, study participation, or follow-up procedures
- No other severe concurrent disease that would preclude study treatment
PRIOR CONCURRENT THERAPY:
- At least 1 week since prior therapy and recovered
- No other concurrent chemotherapy
- Hydroxyurea to control WBC count before starting study treatment allowed
- No concurrent corticosteroids unless used for diseases other than leukemia
- No concurrent palliative radiotherapy
- No concurrent growth factors (e.g., epoetin alfa, filgrastim [G-CSF], or sargramostim [GM-CSF]) in patients with AML
Data sourced from ClinicalTrials.gov (NCT01656031). 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.