Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Study of Clofarabine and Cytarabine for Older Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)(CLASSIC I)
This study is currently recruiting participants.
Verified by Genzyme, July 2008
Sponsored by: Genzyme
Information provided by: Genzyme
ClinicalTrials.gov Identifier: NCT00317642
  Purpose

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.

There is no recommended standard treatment for relapsed or refractory acute myelogenous leukemia in patients older than 59 years. Cytarabine is the most commonly used drug to treat these patients. This study will determine if there is additional benefit by combining clofarabine with cytarabine.


Condition Intervention Phase
Acute Myelogenous Leukemia
Drug: clofarabine (IV formulation) and cytarabine
Drug: placebo and cytarabine
Phase III

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: Cytarabine Cytarabine hydrochloride Clofarabine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase III Randomized, Double-Blind, Controlled Study Comparing Clofarabine and Cytarabine Versus Cytarabine Alone in Adult Patients 55 Years and Older With Acute Myelogenous Leukemia (AML) Who Have Relapsed or Are Refractory After Receiving up to Two Prior Induction Regimens

Further study details as provided by Genzyme:

Primary Outcome Measures:
  • overall survival [ Time Frame: Up to 7 years or duration of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall remission rate [ Time Frame: Up to 7 years or duration of study ] [ Designated as safety issue: No ]
  • duration of remission [ Time Frame: Up to 7 years or duration of study ] [ Designated as safety issue: No ]
  • disease-free survival [ Time Frame: Up to 7 years or duration of study ] [ Designated as safety issue: No ]
  • event-free survival [ Time Frame: Up to 7 years or duration of study ] [ Designated as safety issue: No ]
  • safety and tolerability [ Time Frame: Up to 7 years or duration of study ] [ Designated as safety issue: Yes ]
  • 4-month Event free survival (EFS) [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 376
Study Start Date: September 2006
Estimated Study Completion Date: January 2013
Arms Assigned Interventions
1: Experimental Drug: clofarabine (IV formulation) and cytarabine
clofarabine (IV formulation) infusion 40mg/m^2 / day and cytarabine IV infusion 1g/m^2/day for up to 3 cycles
2: Experimental Drug: placebo and cytarabine
placebo IV infusion and cytarabine IV infusion 1g/m^2/day for up to 3 cycles

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provide signed, written informed consent
  • Have a diagnosis of AML according to World Health Organization (WHO) classification
  • Relapsed after receiving up to 2 prior induction regimens (i.e. first or second relapse)or are refractory to not more than one prior combination chemotherapy induction regimen
  • Be ≥ 55 years of age
  • Have an ECOG score of 0-2
  • Be able to comply with study procedures and follow-up examinations
  • Be nonfertile or agree to use birth control during the study through the end of treatment visit and for at least 90 days after the last dose of study drug
  • Have adequate liver and renal function as indicated by certain laboratory values

Exclusion Criteria:

  • Received previous treatment with clofarabine
  • Received bolus, intermediate or high-dose cytarabine as induction therapy unless certain remission criteria are met
  • Have received a hematopoietic stem cell transplant (HSCT) within the previous 3 months
  • Have moderate or severe graft versus host disease (GVHD), whether acute or chronic
  • Are receiving any other chemotherapy or investigational therapy. Patients must have been off prior AML therapy for at least 2-4 weeks prior to entering study.
  • Have a psychiatric disorder that would interfere with consent, study participation, or follow-up
  • Have an active, uncontrolled infection
  • Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system
  • Have been diagnosed with another malignancy, unless disease-free for at least 5 years; patients with treated melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed; patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease are eligible if hormonal therapy has been initiated or the malignancy has been surgically removed.
  • Have clinical evidence suggestive of central nervous system (CNS) involvement with leukemia unless lumbar puncture confirms absence of leukemic blasts in the cerebrospinal fluid(CSF)
  • Known HIV positivity
  • Are pregnant or lactating
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00317642

Contacts
Contact: Medical Information 800-745-4447 medinfo@genzyme.com
Contact: Medical Information 617-252-7832 medinfo@genzyme.com

  Show 54 Study Locations
Sponsors and Collaborators
Genzyme
  More Information

US FDA Approved Full Prescribing Information for Clolar  This link exits the ClinicalTrials.gov site

Responsible Party: Genzyme ( Medical Monitor )
Study ID Numbers: CLO34100405
Study First Received: April 24, 2006
Last Updated: August 1, 2008
ClinicalTrials.gov Identifier: NCT00317642  
Health Authority: United States: Food and Drug Administration

Keywords provided by Genzyme:
acute myelogenous leukemia
acute myeloid leukemia
relapsed AML
refractory AML
clofarabine
cytarabine
CLO341
clolar

Study placed in the following topic categories:
Clofarabine
Leukemia
Acute myelogenous leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Acute myelocytic leukemia
Cytarabine

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009