Leukemia
Conditions
Keywords
recurrent adult acute lymphoblastic leukemia, recurrent adult acute myeloid leukemia, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute basophilic leukemia, adult acute eosinophilic leukemia, adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myelomonocytic leukemia (M4)
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. 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.
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 clofarabine. OUTLINE: This is an open-label phase II study. Patients are stratified according to diagnosis (acute myeloid leukemia vs acute lymphoblastic leukemia Phase II: Patients receive high-dose cytarabine followed by clofarabine (at the dose determined in phase I) on days 1-3. After completion of study treatment, patients are followed periodically for up to 5 years. PROJECTED ACCRUAL: A total of 39 patients were accrued for this study.
Interventions
DRUGclofarabine
DRUGcytarabine
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure Patient Response to High-dose Cytarabine Followed by Clofarabine in Adult Patients With Relapsed or Refractory AML | 5 weeks | Response to the therapy is measured by a defined improvement in Neutrophil and platlet counts, along with improved cellularity of bone marrow biopsy (\>20% with maturation of all cell lines), \<5% blasts, auer rods must not be detectable and extramedullary leukemia or soft tissue involvment must not be present. |
Countries
United States
Participant flow
Recruitment details
Recruiment began 02/28/2005 and ended 08/06/2008.
Participants by arm
| Arm | Count |
|---|---|
| High-dose Cytarabine and Clofarabine high-dose cytarabine administered intravenously over 3 hours followed by clofarabine administered intravenously over 2 hours daily for 5 consecutive days | 39 |
| Total | 39 |
Baseline characteristics
| Characteristic | High-dose Cytarabine and Clofarabine |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants |
| Age, Continuous | 53.4 years STANDARD_DEVIATION 15.9 |
| Region of Enrollment United States | 39 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 39 / — |
| serious Total, serious adverse events | 39 / 39 |
Outcome results
Primary
Measure Patient Response to High-dose Cytarabine Followed by Clofarabine in Adult Patients With Relapsed or Refractory AML
Response to the therapy is measured by a defined improvement in Neutrophil and platlet counts, along with improved cellularity of bone marrow biopsy (\>20% with maturation of all cell lines), \<5% blasts, auer rods must not be detectable and extramedullary leukemia or soft tissue involvment must not be present.
Time frame: 5 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High-Dose Cytarabine and Clofarabine | Measure Patient Response to High-dose Cytarabine Followed by Clofarabine in Adult Patients With Relapsed or Refractory AML | 17 participants |