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Phase II Study of Clofarabine in Pediatric Acute Lymphoblastic Leukemia (ALL)

Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leukemia, Lymphoblastic, Acute, Pediatric

Intervention: clofarabine (IV formulation) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Genzyme, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Genzyme, a Sanofi Company

Summary

Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. The purpose of this study is to determine whether Clofarabine is safe and effective in the treatment of Acute Lymphoblastic Leukemia (ALL.)

Clinical Details

Official title: A Phase II, Open Label Study of Clofarabine in Pediatric Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia

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

Detailed description: This is a non-randomized, open label, Phase II study of Clofarabine in pediatric patients with refractory or relapsed acute lymphoblastic leukemia (ALL). Eligible patients must be in second or subsequent relapse or be refractory. Forty eligible patients will be enrolled in a Fleming 2-stage sequential study design in order to better assess the efficacy and safety of clofarabine in this patient population.

Eligibility

Minimum age: N/A. Maximum age: 21 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Have a diagnosis of ALL according to FAB classification with greater than or equal to

25% blasts in the bone marrow.

- Be less than or equal to 21 years old at time of initial diagnosis.

- Not be eligible for therapy of higher curative potential, and must be in second or

subsequent relapse and/or refractory. Where an alternative therapy has been shown to prolong survival in an analogous population, this should be offered to the patient prior to discussing this study.

- Have a Karnofsky Performance Status (KPS) of >70.

- Provide signed, written informed consent from parent or guardian and assent from

patients greater than or equal to 7 years old according to local IRB and institutional requirements.

- Be able to comply with study procedures and follow-up examinations.

- Have adequate organ function as indicated by the following laboratory values,

obtained within 2 weeks prior to registration: Serum bilirubin less than or equal to 1. 5 x ULN; AST and ALT less than or equal to 5 x ULN; Serum Creatinine less than 2 x ULN for age. ULN= Institutional Upper Limit of Normal Exclusion Criteria:

- Received previous treatment with Clofarabine.

- Have had a recent (<30 days) history of fungal or serious bacterial infection or who

are receiving therapeutic antibiotics.

- Are pregnant or lactating. Male and female patients who are fertile must agree to

use an effective means of birth control (i. e., latex condom, diaphragm, cervical cap, etc) to avoid pregnancy.

- Have psychiatric disorders that would interfere with consent, study participation, or

follow up.

- Are receiving any other chemotherapy. Patients must have been off previous therapy

for at least 2 weeks (with the exception of intrathecal therapy, which is allowed up to 24hrs prior to 1st of study drug) and must have recovered from acute toxicity of all previous therapy prior to enrollment. Treatment may start earlier, following consultation with the ILEX Medical Monitor, if there is evidence of disease relapse prior to that time.

- Have any other severe concurrent disease, or have a history of serious organ

dysfunction or disease involving the heart, kidney, liver or pancreas.

- Have symptomatic CNS involvement.

- Febrile neutropenia at time of study entry.

- Have received a hematologic stem cell transplant (HSCT) within the previous 3 months

or have active GVHD (greater than or equal to Grade 2).

Locations and Contacts

Children's Hospital, Los Angeles, California 90027, United States

Children's Hospital, Orange County, California, United States

Children's Hospital, San Diego, California, United States

Children's Hospital, Denver, Colorado 80218, United States

Children's Memorial Hospital, Chicago, Illinois 60614, United States

Johns Hopkins Children's Center, Baltimore, Maryland, United States

Children's Hospital, St. Louis, Missouri, United States

Memorial Sloan-Kettering, New York, New York, United States

Children's Hospital, Philadelphia, Pennsylvania, United States

Children's Hospital, Pittsburgh, Pennsylvania 15213, United States

St. Jude Children's Research Hospital, Memphis, Tennessee, United States

Cook's Children's Medical Center, Fort Worth, Texas 76104, United States

Texas Children's Cancer Center, Houston, Texas, United States

The University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States

Additional Information

Results synopsis for CLO212

Starting date: May 2002
Last updated: March 17, 2014

Page last updated: August 20, 2015

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