A Study of Clofarabine for Older Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) (CLASSIC II)
Summary
Clolar (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.
This study will evaluate the efficacy of clofarabine in elderly patients with AML who may not benefit from or tolerate treatment with other chemotherapy drugs used in younger patients with AML (cytarabine and anthracyclines)
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Acute Myelogenous Leukemia
Intervention
clofarabine (IV formulation)
Location
Mayo Clinical Hospital
Phoenix
Arizona
United States
Status
Active, not recruiting
Source
Genzyme
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00373529
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Leukemia, Eosinophilic, Acute
A rare acute myeloid leukemia characterized by abnormal EOSINOPHILS in the bone marrow.
Leukemia, Promyelocytic, Acute
An acute myeloid leukemia in which abnormal PROMYELOCYTES predominate. It is frequently associated with DISSEMINATED INTRAVASCULAR COAGULATION.
Leukemia, Biphenotypic, Acute
An acute leukemia exhibiting cell features characteristic of both the myeloid and lymphoid lineages and probably arising from MULTIPOTENT STEM CELLS.
Preleukemia
Conditions in which the abnormalities in the peripheral blood or bone marrow represent the early manifestations of acute leukemia, but in which the changes are not of sufficient magnitude or specificity to permit a diagnosis of acute leukemia by the usual clinical criteria.
Leukemia, Monocytic, Acute
An acute myeloid leukemia in which 80% or more of the leukemic cells are of monocytic lineage including monoblasts, promonocytes, and MONOCYTES.
Clinical Trials
Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients
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...
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...
Investigation of Clofarabine in Acute Leukemias
The goals and objectives of this project are to evaluate the antileukemic activity of the investigational agent clofarabine in patients with acute myelogenous leukemia (AML), acute lymphoc...
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...
T2007-002 Clofarabine, Etoposide, Cyclophosphamide in Relapsed Acute Myelogenous Leukemia (AML)
Clofarabine is a drug approved by the FDA (Food and Drug Administration) for treating children (age 1-21) with leukemia. This research study will use clofarabine with two other cancer figh...
PubMed Articles
Use of clofarabine for acute childhood leukemia.
A second-generation of purine nucleoside analogs, starting with clofarabine, has been developed in the course of the search for new therapeutic agents for acute childhood leukemia, especially for refr...
PURPOSE To compare the receipt of clofarabine plus cytarabine (Clo+Ara-C arm) with cytarabine (Ara-C arm) in patients ≥ 55 years old with refractory or relapsed acute myelogenous leukemia (AML). PAT...
ABSTRACT Clofarabine is a promising, new chemotherapeutic agent that is active in the treatment of pediatric acute leukemia. Forty children ( 16 AML, 24 ALL), aged 1-20 years (median 7.6 years) with...
Clofarabine for myelodysplastic syndromes.
Introduction: Treatment options in myelodysplastic syndromes (MDS) remain limited. The introduction of novel therapies that can improve response rates and survival outcomes in MDS remains a challenge....
We conducted a phase I trial to determine the maximum tolerated dose (MTD) of clofarabine with high-dose busulfan followed by allogeneic stem cell transplantation (SCT) in patients with high-risk and...
