Clinical trial NCT01656031: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia
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)
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-08-02
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Measure Patient Response to High-dose Cytarabine Followed by Clofarabine in Adult Patients With Relapsed or Refractory AML
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Bayard L. Powell, MD
role: STUDY_CHAIR
References: