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

Overview

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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