E7070, Idarubicin and Cytarabine in Relapsed AML and High-Risk Myelodysplastic Syndromes
|ClinicalTrials.gov Identifier: NCT01692197|
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : June 15, 2017
|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: Stage 1: E7070
Stage 1: E7070 400 mg/m2 by vein (IV) over 1 hour on day 1 and day 8 (+/- 2 days on Day 8 only). If at assessment participant found to be in CR, CRp, PR or marrow clearance of blasts, they may receive post-remission therapy with E7070 400 mg/m2 IV over 1 hour on day 1 and day 8 (+/- 2 days on Day 8 only) every 3 weeks for up to five additional cycles as long as clinical benefit continues.
400 mg/m2 intravenously over 1 hour on Day 1 and Day 8 every 3 weeks.
Experimental: Stage 2: E7070 + Idarubicin + Cytarabine
Stage 2: 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.Drug: Idarubicin
8 mg/m2 by vein over 1 hour daily for 3 days (Days 9-11).
Other Name: IdamycinDrug: Cytarabine
1.0 g/m2 by vein daily on Days 9 - 12 (age <60 years) or Days 9 - 11 (age > 60 years).
Other Names:Drug: Dexamethasone
10 mg by vein daily for 3 - 4 days with cytarabine.
Other Name: Decadron
- Overall Response [ Time Frame: 21 days ]Efficacy measured by overall response - complete response plus complete response with incomplete platelet recovery, plus partial response (CR + CRp + PR+ marrow clearance of blast) during Stage 1 and 2.
- Toxicity Profile [ Time Frame: 28 days ]Bayesian sequential monitoring method (Thall, 1995) used to monitor toxicity. Toxic event defined as death or a CTCAE 4.0 grade 3/4 non-hematological toxicity related to study drug lasting or 7 days or more. Toxicity reported by type, frequency and severity. Worst toxicity grades per patient tabulated for selected adverse events and laboratory measurements.
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|