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MLN 9708 in Induction and Consolidation for Adults With AML >= 60 Years of Age | Clinical Trials | Clareo Health

COMPLETEDPHASE1

MLN 9708 in Induction and Consolidation for Adults With AML >= 60 Years of Age

Phase I Dose Escalation Study of Millennium 9708 in Combination With Induction and Consolidation Chemotherapy in Adults >= 60 Years With Acute Myeloid Leukemia

NCT02582359•Massachusetts General Hospital

View on ClinicalTrials.gov

Summary

This research study is evaluating drugs called Millennium 9708 (referred to as MLN9708) in combination with standard therapy for acute myeloid leukemia (AML) consisting of daunorubicin and cytarabine as a possible treatment for the patient AML.

Detailed Description

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.

Eligibility

Age

60 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female patients 60 years or older.
•Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
•Female patients who:
•* Are postmenopausal for at least 1 year before the screening visit, OR
•* Are surgically sterile, OR
•* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND
•* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR
•* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[eg, calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception.)
•Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:
•* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR
+8 more criteria

Exclusion Criteria

•Female patients who are lactating or have a positive serum pregnancy test during the screening period.
•Failure to have fully recovered (ie, ≤Grade 1 toxicity) from the reversible effects of prior chemotherapy as stated in Section 5.1.4.
•Major surgery within 14 days before enrollment.
•Radiotherapy within 14 days before enrollment. If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the MLN9708.
•Suspected AML-related central nervous system involvement. A lumbar puncture (LP) is not required to exclude central nervous system (CNS) disease.
•Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
•Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive.
•Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
•Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
•Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of MLN9708 including difficulty swallowing.
+7 more criteria

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Key Dates

Start Date

January 1, 2016

Primary Completion Date

April 1, 2022

Completion Date

April 1, 2022

Last Updated

August 24, 2022

Enrollment

ACTUAL participants

Conditions

Acute Myeloid Leukemia

Interventions

MLN9708

DRUG

Cytarabine

DRUG

Daunorubicin

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 24, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

MLN 9708 in Induction and Consolidation for Adults With AML >= 60 Years of Age

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2

Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes

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