Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00334074
Status:
COMPLETED
Last Update Posted:
2013-07-17
First Post:
2006-06-02
Brief Title:
Clofarabine and Ara-C for the Treatment of Relapsed AML and Untreated MDS
Sponsor:
Baylor Research Institute
Organization:
Baylor Research Institute
Study Overview
Official Title:
Phase II Trial of Clofarabine and Cytarabine in Relapsed Standard-Risk AML and Untreated High-Risk MDS in Adult Patients and Untreated AML in Selected Elderly Patients at High Risk of Anthracycline Toxicity
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is to to determine the safety and effectiveness of therapeutic combination - Clofarabine and Cytarabine for the treatment of AML and MDS
Detailed Description:
Previous studies of Clofarabine and Cytarabine combination treatment in adult AML and MDS patients showed promising results
This study is done to confirm the findings from previous studies Primary objective is to determine the overall response rate complete response CR plus partial response PR secondary objective of this study is to characterize and quantify the toxicity profile associated with clofarabine plus cytarabine treatment
A maximum of 35 patients will be treated on this study They will receive 5 consecutive days of clofarabine intra venous infusion IVI followed 4 hours later by cytarabine IVIPatients will receive up to a maximum of 4 cycles of study treatment Next cycle will start approximately 4 weeks after Day 1 of previous cycleNo other investigational or commercial agents including chemotherapy radiotherapy or immunotherapy may be administered to patients enrolled in this study with the intention of treating the underlying malignancy
Patients will remain on study and be monitored until 4 months have elapsed from the beginning date of their last cycle of treatment
This study is done to confirm the findings from previous studies Primary objective is to determine the overall response rate complete response CR plus partial response PR secondary objective of this study is to characterize and quantify the toxicity profile associated with clofarabine plus cytarabine treatment
A maximum of 35 patients will be treated on this study They will receive 5 consecutive days of clofarabine intra venous infusion IVI followed 4 hours later by cytarabine IVIPatients will receive up to a maximum of 4 cycles of study treatment Next cycle will start approximately 4 weeks after Day 1 of previous cycleNo other investigational or commercial agents including chemotherapy radiotherapy or immunotherapy may be administered to patients enrolled in this study with the intention of treating the underlying malignancy
Patients will remain on study and be monitored until 4 months have elapsed from the beginning date of their last cycle of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 004-145 | OTHER | Baylor Internal Review Board | None |