MLN 9708 in Induction and Consolidation for Adults With AML >= 60 Years of Age
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|ClinicalTrials.gov Identifier: NCT02582359|
Recruitment Status : Recruiting
First Posted : October 21, 2015
Last Update Posted : November 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: MLN9708 Drug: Cytarabine Drug: Daunorubicin||Phase 1|
This research study is a clinical trial comprised of two Phase I portions an induction treatment (initial treatment), and a consolidation treatment (which is given later). The patient is being asked to participate in one or both phase I portions of this study.
A phase I study tests the safety of an investigational drug or combination of drugs. Phase I studies also try to define the appropriate dose of the investigational drugs to use for further studies. "Investigational" means that the drug combination is being studied. It also means that the FDA (U.S. Food and Drug Administration) has not approved the drug combination for the participant's type of cancer.
In this research study, the investigators are studying the safety and tolerability of MLN9708 in combination with standard treatment for adults 60 years of age or older with AML.
In the first phase I portion of treatment ("induction") participants will receive MLN9708 in combination with daunorubicin and cytarabine. Once the maximally tolerated dose (MTD) of MLN9708 is established in this induction portion, up to 36 additional participants will be enrolled in the portion focusing on consolidation.
The drugs daunorubicin and cytarabine have been approved by the FDA (U.S. Food and Drug Administration). MLN9708 is not approved by the FDA.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Dose Escalation Study of Millennium 9708 in Combination With Induction and Consolidation Chemotherapy in Adults >= 60 Years With Acute Myeloid Leukemia|
|Actual Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||February 2022|
Phase I dose escalation study of MLN9708 with induction chemotherapy
Phase I dose escalation study of MLN9708 with consolidation chemotherapy after establishment of MTD with induction
Dose of 1.5 mg or 2.3 mg or 3.0 mg taken by mouth on days 2, 5, 9, 12 of each cycle.
Other Name: Ixazomib
Induction: cytarabine 100 mg/m2/day continuous infusion, days 1-7 Consolidation: cytarabine 2000 mg/m2/day, 3 hour infusion, on days 1-5
Daunorubicin 60 mg/m2, IV bolus, on days 1-3 of induction, only.
Other Name: Cerubidine®
- MTD/recommended phase 2 dose (RP2D) of MLN9708 in combination with induction chemotherapy [ Time Frame: 1 year ]Safety of MLN9708 in induction
- MTD/RP2D of MLN9708 with combination with consolidation chemotherapy [ Time Frame: 1 year ]Safety of MLN9708 in consolidation tested separately
- Dose Limiting Toxicities of MLN9708 [ Time Frame: 1 year ]Generally by NCI CTCAE: grade 3 neuropathy, grade 3 non-hematological toxicity that does not resolve to grade 2, grade 4 hematological toxicity not due to persistent AML that persists
- Disease Free Survival (DFS) [ Time Frame: 2 Years: Complete remission (CR) or complete remission without platelet recovery (CRp) to relapse or death, whichever comes first, for patients who receive study drug in induction and regardless of consolidation therapy ]Duration in weeks or months from determination of remission to time of relapse or death
- Overall Survival (OS) [ Time Frame: 2 Years ]Duration in weeks or months from day 1 of protocol treatment to time of death
- Remission Rate [ Time Frame: 2 years ]Percentage of patients starting day 1 treatment that achieve a remission (CR or CRp)
- Relationship between CD74 expression and remission, DFS, OS [ Time Frame: 2 Years ]Degree of CD74 expression on leukemia blasts compared to the rate of remission and length of DFS and OS.
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): NCT02582359
|Contact: Philip C Amrein, MD||617-724-1124|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Philip C Amrein, MD 617-724-1124|
|Principal Investigator: Philip C Amrein, MD|
|Principal Investigator:||Philip C Amrein, MD||Massachusetts General Hospital|