Clofarabine Bone Marrow Cytoreduction
|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.|
- Cytoreductive Response [ Time Frame: Day 12 ] [ Designated as safety issue: No ]Percent of patients achieving cytoreductive response of marrow cellularity <20% and blasts < 10%
- 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 ]
- Number of Participants With Skin Adverse Events [ Time Frame: Day 12 ] [ Designated as safety issue: Yes ]
- Number of Participants Infection Adverse Events [ Time Frame: Day 12 ] [ Designated as safety issue: Yes ]
- Leukemia Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]Time to event analysis used the day of transplant as day 0.
|Study Start Date:||December 2007|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days
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
Hide Detailed Description
Screening will be done prior to enrollment in the study. The following will be done as part of the screening process:
- Medical history review
- Physical exam
- Measurement of vital Signs
- Blood tests (approximately 6 teaspoons of blood) will be done to see if the liver and kidneys are healthy, HIV (the virus that causes AIDS) test for this study and pregnancy test.
- Urine test
- Bone marrow biopsy and aspirate
If the patient is ineligible or does not have a donor for Allogeneic Stem Cell transplantation, you will not be able to participate in this clinical trial.
After results of these tests are obtained, your doctor will decide whether you can participate in this study.
The study drug will be given for 5 days.
Days 1 through 5:
The patient will receive dexamethasone 1.5 hours prior to the administration of Clofarabine as part of standard care for subjects receiving Clofarabine.
The patient will receive an intravenous (IV) injection (into the vein) of Clofarabine each day for 5 days. This injection is given in the hospital and will be given over approximately 60 minutes each day. The actual dose of Clofarabine is based on the weight and height of the subject.
The patient will have the following tests done to see the effects of the study drug:
Each day of Clofarabine administration, on day 12 and then each day until stem cell transplantation:
- Physical exam
- Vital signs
- Blood tests. About 3-4 teaspoons will be taken each time.
Day 12 after Clofarabine administration and then as outlined for stem cell transplantation:
• Bone marrow biopsy and aspirate.
After Clofarabine administration, there will be short resting period of 7-14 days. After the resting period, the patient will start receiving conditioning chemotherapy regimen (other standard of care drugs to better prepare your body for the stem cell transplant). This regimen will begin 15-21 days after they first received Clofarabine, and consists of additional treatment (chemotherapy and/or radiation). The type of treatment(s) the patient will receive for conditioning is dependent on the type of disease. In addition, this treatment will be decided by your doctor and is independent of this research. The duration of the conditioning period is variable and may take between 5-8 days. Stem cells are usually given one day after the completion of this regimen, which will be between 21 and 30 days after the patient has first received Clofarabine.
Follow-up Subjects who have a response and proceed with stem cell transplant will be followed weekly for the first three months and then every month for six months, then every two months for 12 months, then every three months for 18 months. The stem cell transplant will be done 21-30 days after first receiving Clofarabine. Subjects who do not go on to stem cell transplant will be followed for 3 months following administration of Clofarabine.
At these visits, the following will be done:
- A physical exam
- Medical history
- Blood tests (about 3 teaspoons blood will be taken) performed.
End of study
At this time, the following tests will be done:
- Physical exam
- Blood tests
- Bone marrow biopsy
Please refer to this study by its ClinicalTrials.gov identifier: NCT00724009
|United States, Illinois|
|The University of Chicago hospitals|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Wendy Stock, MD||University of Chicago|