Status:
COMPLETED
Cytarabine and Clofarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief 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. Giv...
Detailed Description
OBJECTIVES: * Determine the response rate in adult patients with relapsed or refractory acute myeloid leukemia or acute lymphoblastic leukemia treated with high-dose cytarabine followed by clofarabin...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2015
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00295841
Start Date
February 1 2005
End Date
January 7 2015
Last Update
August 10 2018
Active Locations (1)
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1
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096