Decitabine Followed by Clofarabine, Idarubicin, and Cytarabine in Acute Leukemia
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|ClinicalTrials.gov Identifier: NCT01794702|
Recruitment Status : Completed
First Posted : February 20, 2013
Results First Posted : May 10, 2019
Last Update Posted : May 30, 2019
The goal of Phase I of this clinical research study is find the highest tolerable dose of clofarabine that can be given with decitabine, idarubicin, and cytarabine to patients with acute leukemia.
The goal of Phase II of this study is to learn if decitabine followed by the combination of clofarabine, idarubicin, and cytarabine can help to control acute leukemia. The safety of this drug combination will also be studied.
Decitabine and idarubicin are designed to damage the DNA (the genetic material of cells). This may cause cancer cells to die.
Clofarabine is designed to interfere with the growth and development of cancer cells.
Cytarabine is designed to insert itself into DNA and stop the DNA from repairing itself.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: Decitabine Drug: Idarubicin Drug: Cytarabine Drug: Clofarabine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||
Starting with Dose level 1, the participants were enrolled by cohort of 3. Once the DLT assessment is completed, another cohort of 3 patients will be enrolled. If at any time, we see more than 30% patients experiencing DLT, we will de-escalate to dose level (-1).
Period 1: Dose level 1 Clofarabine 15mg/m^2 daily x 4 days (days 6-9)
Period 2: Dose level-1 Clofarabine 15mg/m^2 daily x 3 days (days 6-8)
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Decitabine (DAC) Followed by Clofarabine, Idarubicin, and Cytarabine (CIA) in Acute Leukemia|
|Actual Study Start Date :||February 20, 2013|
|Actual Primary Completion Date :||January 11, 2018|
|Actual Study Completion Date :||January 11, 2018|
Experimental: Clofarabine + Cytarabine + Decitabine + Idarubicin
Phase I - Decitabine 20 mg/m2 by vein over approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 6-10)
Phase II - Clofarabine 15 mg/m2 by vein over approximately 1 hour daily (number of days selected based on Phase I portion).
Decitabine 20 mg/m2 by vein over approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 6-10)
Phase I and II - 20 mg/m2 by vein daily for 5 days (days 1-5)
Other Name: Dacogen
Phase I and II - 10 mg/m2 by vein daily for 3 days (days 6-8)
Other Name: Idamycin
Phase I and II - 1 g/m2 by vein daily for 5 days (days 6-10)
Phase I Starting Dose - 15 mg/m2 by vein daily for 4 days (days 6-9)
Phase II Starting Dose - Maximum tolerated dose from Phase I (number of days selected based on Phase I portion).
- Maximum Tolerated Dose (MTD) of Clofarabine [ Time Frame: After second, 33 day cycle ]Maximum tolerated dose (MTD) defined as the highest dose schedule in which 6 patients were treated with at most 1 experiencing a dose-limiting toxicity (DLT). Clofarabine 15 mg/m2 IV over approximately 1 hour daily (number of days selected based on Phase I portion).
- Number of Participants With a Response [ Time Frame: 56 days ]Primary endpoint is overall response defined as the best response either complete response, complete remission without platelet recovery, or complete remission without incomplete blood count recovery within 56 days.
- To Determine the Disease-free Survival (DFS). [ Time Frame: Up to 2 years after participants off study date ]Time from date of treatment start until the date of first objective documentation of return of disease.
- Overall Survival [ Time Frame: Up to 2 years after participants off study date ]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): NCT01794702
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Nitin Jain, MBBS||M.D. Anderson Cancer Center|