E7070, Idarubicin and Cytarabine in Relapsed AML and High-Risk Myelodysplastic Syndromes
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|ClinicalTrials.gov Identifier: NCT01692197|
Recruitment Status : Completed
First Posted : September 25, 2012
Results First Posted : July 3, 2018
Last Update Posted : July 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: E7070 Drug: Idarubicin Drug: Cytarabine Drug: Dexamethasone||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of E7070, Idarubicin and Cytarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia and High-risk Myelodysplastic Syndromes|
|Actual Study Start Date :||February 1, 2013|
|Actual Primary Completion Date :||June 7, 2017|
|Actual Study Completion Date :||June 7, 2017|
Experimental: E7070 + Idarubicin + Cytarabine
E7070 400 mg/m2 IV over 1 hour on day 1 and day 8 (+/- 2 days on Day 8 only) followed by, Idarubicin 8 mg/m2 IV over 1 hour daily for 3 days (days 9-11) and Cytarabine 1.0 g/m2 IV over 24 hours daily on day 9-12 (age <60 years) or days 9-11 (age > 60 years). Dexamethasone 10 mg IV daily for 3-4 days with cytarabine.
400 mg/m2 intravenously over 1 hour on Day 1 and Day 8 every 3 weeks.
8 mg/m2 by vein over 1 hour daily for 3 days (Days 9-11).
Other Name: Idamycin
1.0 g/m2 by vein daily on Days 9 - 12 (age <60 years) or Days 9 - 11 (age > 60 years).
10 mg by vein daily for 3 - 4 days with cytarabine.
Other Name: Decadron
- Overall Response [ Time Frame: 2 cycles (60 days) ]Efficacy measured by overall response - complete response plus complete response with incomplete platelet recovery, plus partial response (Complete remission (CR) + Complete remission without platelet recovery (CRp) + Partial Remission (PR)+ marrow clearance of blast) during cycle 1.
- Disease-free Survival [ Time Frame: Up to 5 years ]Time from date of treatment start until the date of first objective documentation of disease-relapse.
- Duration of Response [ Time Frame: Up to 5 years ]Response date to loss of response or last follow up.
- Overall Survival [ Time Frame: Up to 5 years ]Time from date of treatment start until date of death due to any cause or last follow-up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01692197
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Gautam Borthakur, MBBS||M.D. Anderson Cancer Center|