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A Phase 1/2 Dose-Escalation Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Pediatric Patients With Refractory or Relapsed Acute Leukemias.


Phase 1/Phase 2
1 Year
21 Years
Not Enrolling
Both
Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Relapsed Leukemia

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Trial Information

A Phase 1/2 Dose-Escalation Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Pediatric Patients With Refractory or Relapsed Acute Leukemias.


Inclusion Criteria:



- NOTE: the following eligibility criteria were applicable to acute lymphoblastic
leukemia (ALL) and acute myelogenous leukemia (AML) patients for the Phase 1 portion
of this study, and to ALL patients for the Phase 2 portion of the study (only ALL
patients were allowed in the Phase 2 portion of the study).

- ALL with > 25% blasts in bone marrow; AML with ≥ 5% blasts in bone marrow; ALL and
AML patients may have extramedullary disease

- Karnofsky Performance Status ≥ 50 for patients > 10 years old; Lansky Performance
Status ≥ 50 for patients ≤ 10 years old

- Prior therapy: AML: 1-2 prior induction regimens and ≤ 1 hematopoietic stem cell
transplant (HSCT); ALL: 1-3 prior induction regimens

- Adequate liver, renal, pancreatic, and cardiac function

- Have received no prior HSCT (study amended in Phase 2 to exclude patients with prior
HSCT)

Exclusion Criteria:

- NOTE: the following eligibility criteria were applicable to ALL and AML patients for
the Phase 1 portion of this study, and to ALL patients for the Phase 2 portion of the
study (only ALL patients were allowed in the Phase 2 portion of the study).

- Burkitt's leukemia

- Previous treatment with clofarabine

- Uncontrolled systemic fungal, bacterial or other infection and 48 hrs negative blood
cultures required for patients with a history of fever within 3 days of enrollment

- Active CNS involvement (i.e., should be CNS1 or CNS2)

- Inadequate time since last therapy: ≤ 14 days since last cytotoxic chemotherapy; ≤ 7
days since last biologic therapy; ≤ 14 days since last monoclonal antibody therapy

- Have received prior HSCT (study amended in Phase 2 to exclude patients with prior
HSCT)

- Pregnant or lactating

- Have tested positive for hepatitis B or hepatitis C infection or history of cirrhosis

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) in Phase 1

Outcome Description:

The MTD was to be the highest dose level of clofarabine in combination with etoposide and cyclophosphamide that caused <= 1 of 6 participants to experience a dose limiting toxicity (DLT) with the next higher dose level having at least 2 of 3 or 2 of 6 participants experiencing a DLT. The MTD would be used as the recommended phase 2 dose (RP2D). If the MTD could not be determined, then the target dose of clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 as taken by Cohort 5 was to become the RP2D. The rating scale used is 0 = not the MTD, 1 = the MTD.

Outcome Time Frame:

Up to Day 42 (Phase 1 portion of study)

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Genzyme

Authority:

United States: Food and Drug Administration

Study ID:

CLO21800205

NCT ID:

NCT00315705

Start Date:

March 2006

Completion Date:

May 2010

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Acute Myelogenous Leukemia
  • Relapsed Leukemia
  • clofarabine
  • acute leukemia
  • ALL
  • AML
  • clolar
  • CLO218
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Children's Hospital of MichiganDetroit, Michigan  48201
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Children's Hospital of AlabamaBirmingham, Alabama  35233
Connecticut Children's Medical CenterHartford, Connecticut  06106
Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of Texas MD Anderson Cancer CenterHouston, Texas  77030
Children's Memorial HospitalChicago, Illinois  60614
Seattle Children's HospitalSeattle, Washington  98105
Rady Children's HospitalSan Diego, California  92123
Children's Hospital of Los AngelesLos Angeles, California  90027
St. Vincent Children's HospitalIndianapolis, Indiana  
New York School of MedicineNew York, New York