Clofarabine Bone Marrow Cytoreduction
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Chicago.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Chicago
Collaborator:
Genzyme
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00724009
First received: July 25, 2008
Last updated: September 1, 2010
Last verified: September 2010
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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 |
|---|---|
|
Leukemia |
Drug: Clofarabine |
| Study Type: | Interventional |
| Study Design: | 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:
- 66% of patients given clofarabine induction will achieve a cytoreductive response. [ Time Frame: Day 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- leukemia free survival, treatment-related toxicity [ Time Frame: Day 100 ] [ Designated as safety issue: Yes ]
| Enrollment: | 29 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
-
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
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
Investigators
| Principal Investigator: | Wendy Stock, MD | University of Chicago |
More Information
No publications provided
| Responsible Party: | Wendy Stock, MD, Professor, The University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00724009 History of Changes |
| Other Study ID Numbers: | 15809B |
| Study First Received: | July 25, 2008 |
| Last Updated: | September 1, 2010 |
| 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 Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013