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
Information provided by:
University of Chicago
First received: July 25, 2008
Last updated: September 1, 2010
Last verified: September 2010
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.
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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.
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 ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2011 (Final data collection date for primary outcome measure)
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
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00724009
|The University of Chicago hospitals
|Chicago, Illinois, United States, 60637 |
University of Chicago
||Wendy Stock, MD
||University of Chicago
No publications provided
||Wendy Stock, MD, Professor, The University of Chicago
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 25, 2008
||September 1, 2010
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 23, 2013
Neoplasms by Histologic Type
Bone Marrow Diseases