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
Condition: Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: clofarabine; cytarabine
Intervention MeSH terms: Cytarabine; Clofarabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
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)

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