Clofarabine Bone Marrow Cytoreduction

This study has been completed.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00724009
First received: July 25, 2008
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Leukemia
Drug: Clofarabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Cytoreductive Response [ Time Frame: Day 12 ] [ Designated as safety issue: No ]
    Percent of patients achieving cytoreductive response of marrow cellularity <20% and blasts < 10%


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

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

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

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

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

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

  • Leukemia Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Time to event analysis used the day of transplant as day 0.


Enrollment: 29
Study Start Date: December 2007
Study Completion Date: September 2012
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00724009     History of Changes
Other Study ID Numbers: 15809B
Study First Received: July 25, 2008
Results First Received: January 30, 2014
Last Updated: January 30, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Leukemia
Myelodysplastic Syndromes
Myeloproliferative Disorders
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Clofarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014