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Clofarabine Bone Marrow Cytoreduction

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ClinicalTrials.gov Identifier: NCT00724009
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : March 18, 2014
Last Update Posted : March 18, 2014
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
For relapsed and refractory leukemia patients induction chemotherapy prior to initiating a conditioning regimen will decrease residual leukemia (as measured by bone marrow leukemia blast percentage) at the time of HCT. This should lead to reduced relapse while still maintaining low transplant related mortality.

Condition or disease Intervention/treatment Phase
Leukemia Drug: Clofarabine Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clofarabine Bone Marrow Cytoreduction : Feasibility of Induction as a Bridge to Allogeneic Stem Cell Transplantation for Patients With Relapsed or Refractory Acute Leukemias, Myelodysplastic Syndromes, and Advanced Myeloproliferative Diseases.
Study Start Date : December 2007
Primary Completion Date : September 2010
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia
Drug Information available for: Clofarabine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Clofarabine
Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days
Drug: Clofarabine
Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line.
Other Name: Clolar



Primary Outcome Measures :
  1. Cytoreductive Response [ Time Frame: Day 12 ]
    Percent of patients achieving cytoreductive response of marrow cellularity <20% and blasts < 10%


Secondary Outcome Measures :
  1. Number of Participants With Renal Adverse Events [ Time Frame: Day 12 ]
    Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

  2. Number of Participants With Hepatic (Total Bilirubin) Adverse Events [ Time Frame: Day 12 ]
    Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

  3. Number of Participants With Hepatic (SGOT) Adverse Events [ Time Frame: Day 12 ]
    Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

  4. Number of Participants With Cardiac Adverse Events [ Time Frame: Day 12 ]
    Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

  5. Number of Participants With Skin Adverse Events [ Time Frame: Day 12 ]
    Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

  6. Number of Participants Infection Adverse Events [ Time Frame: Day 12 ]
    Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

  7. Leukemia Free Survival [ Time Frame: 2 years ]
    Time to event analysis used the day of transplant as day 0.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
  • Adequate hepatobiliary function as indicated by the following laboratory values:

    • SGOT/SGPT <=2.5 x upper limit of normal
    • Alkaline phosphatase <=2.5 x upper limit of normal
    • Serum bilirubin < 1.5 mg/dl
    • Adequate renal function as indicated by the following laboratory values:
    • Creatinine Clearance >50 ml/min
  • Age >/=18 years
  • Zebroid performance status </= 2 (See Appendix A)
  • Life expectancy is not severely limited by concomitant illness (i.e. < 3months life expectancy from non-leukemic conditions).
  • No evidence of chronic active hepatitis or cirrhosis.
  • HIV-negative
  • Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
  • Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.

Exclusion Criteria:

  • Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
  • Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea. The patient must have recovered from all acute non-hematologic toxicities from any previous .
  • 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 that may place the patient at undue risk to undergo treatment.
  • Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
  • Pregnant or lactating patients.
  • Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00724009


Locations
United States, Illinois
The University of Chicago hospitals
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Wendy Stock, MD University of Chicago

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00724009     History of Changes
Other Study ID Numbers: 15809B
First Posted: July 29, 2008    Key Record Dates
Results First Posted: March 18, 2014
Last Update Posted: March 18, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Leukemia
Neoplasms by Histologic Type
Neoplasms
Clofarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents