Clofarabine Bone Marrow Cytoreduction

NCT00724009 | Completed Phase 2 Results

• 1 other identifier: 15809B
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia

Outcome Measures

Primary Outcomes (1)

• Cytoreductive Response

  Percent of patients achieving cytoreductive response of marrow cellularity \<20% and blasts \< 10%

  Day 12

Secondary Outcomes (7)

• Number of Participants With Renal Adverse Events

  Day 12

• Number of Participants With Hepatic (Total Bilirubin) Adverse Events

  Day 12

• Number of Participants With Hepatic (SGOT) Adverse Events

  Day 12

• Number of Participants With Cardiac Adverse Events

  Day 12

• Number of Participants With Skin Adverse Events

  Day 12

Study Arms (1)

Clofarabine

EXPERIMENTAL

Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days

Drug: Clofarabine

Interventions

Clofarabine DRUG

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.

Also known as: Clolar

Clofarabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

The University of Chicago hospitals

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Leukemia

Interventions

Clofarabine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Nucleotides; Ribonucleotides

Results Point of Contact

• Title: Wendy Stock, MD
• Organization: The University of Chicago

wstock@medicine.bsd.uchicago.edu

773-834-8982

Study Officials

• Wendy Stock, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 29, 2008
• Study Start: December 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2012
• Last Updated: March 18, 2014
• Results First Posted: March 18, 2014

Record last verified: 2014-01

Locations

US (1)