A Study Using Clofarabine and Cytarabine in Treating Children with Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia


NCT ID: NCT00372619
Sponsor Protocol Number: AAML0523

About this study

Drugs used in chemotherapy, such as clofarabine and cytarabine, 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.

The purpose of this trial is studying the side effects and best dose of clofarabine when given together with cytarabine and to see how well they work in treating young patients with refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia. (Phase I closed to enrollment as of 09/16/09)

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Histologically confirmed diagnosis of 1 of the following:
    • Acute myeloid leukemia (AML) with ≥ 5% blasts in the bone marrow (M2/M3 bone marrow) with or without extramedullary disease
    • Acute lymphoblastic leukemia (ALL) with > 25% blasts in the bone marrow (M3 bone marrow) with or without extramedullary disease
    • Acute leukemia of ambiguous lineage with ≥ 5% blasts in the bone marrow (M2/M3 bone marrow) with or without extramedullary disease
  • Disease must have relapsed after or be refractory to prior induction therapy
    • Patients with AML or acute leukemia of ambiguous lineage must be in first relapse OR refractory to first induction therapy with ≤ 1 attempt at remission induction
      • Patients with AML who enroll on the phase I portion of the study must have received prior mitoxantrone hydrochloride and cytarabine for newly diagnosed AML (phase I closed to accrual as of 09/16/09)
    • Patients with ALL must be in second or third relapse (≤ 3 prior induction regimens) OR refractory to reinduction in first relapse
      • Patients with ALL refractory to first induction therapy are not eligible
  • No acute promyelocytic leukemia
  • No CNS 3 involvement (i.e., WBC ≥ 5/μL in the cerebrospinal fluid with blasts present on cytospin)
  • Karnofsky performance status (PS) 50-100% (> 16 years of age) OR Lansky PS 50-100% (≤ 16 years of age) OR ECOG PS 0-2
  • Life expectancy ≥ 8 weeks
  • Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min
  • Direct bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT < 2.5 times ULN (unless it is related to leukemic involvement)
  • Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 45% by gated radionuclide study
  • No evidence of dyspnea at rest or exercise intolerance
  • Pulse oximetry > 94% at room air
  • Amylase ≤ 1.5 times ULN
  • Lipase < 1.5 times ULN
  • No active, uncontrolled grade 3 or 4 infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
  • No known hepatitis B or C infection or history of cirrhosis
  • Recovered from all prior therapy
  • At least 14 days since prior cytotoxic therapy (except hydroxyurea and intrathecal chemotherapy)
  • At least 7 days since prior biologic agent
  • At least 14 days since prior monoclonal antibody therapy
  • No more than 1 prior autologous or allogeneic hematopoietic stem cell transplantation
    • No evidence of active graft-vs-host disease
    • At least 4 months since transplantation
  • No other concurrent chemotherapy or immunomodulating agents
  • No other concurrent investigational therapy 
  • Patients who relapse during ALL maintenance therapy do not require a waiting period.

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