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A Phase I 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

Phase 1
18 Years
Open (Enrolling)

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Trial Information

A Phase I 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


- 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

- Document the safety profile and tolerability of this regimen in these patients.

- Phase I: Patients receive high-dose cytarabine IV over 3 hours followed by clofarabine
IV over 2 hours on days 1-5. Treatment repeats for up to 4 courses (1-2 induction
courses, 2-3 post-remission courses) in the absence of disease progression or
unacceptable toxicity.

A cohort of 3-6 patients receives the starting dose of clofarabine. If 1 of 6 patients
experiences dose-limiting toxicity (DLT), a subsequent cohort of patients receives
clofarabine at the next higher dose. If ≥ 2 of 6 patients experience DLT, the dose of
cytarabine is reduced and subsequent cohorts of patients receive cytarabine at reduced doses
and clofarabine as per the dose-escalation scheme above.

PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study.

Inclusion Criteria


- 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


- 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


- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Safety Issue:


Principal Investigator

Bayard L. Powell, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University


United States: Federal Government

Study ID:




Start Date:

February 2005

Completion Date:

Related Keywords:

  • Leukemia
  • 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)
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096