← Back to Search

Antimetabolite

MLN9708 for Acute Myeloid Leukemia

Phase 1
Waitlist Available
Led By Philip C Amrein, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This study is evaluating whether a drug called Millennium 9708 may help treat acute myeloid leukemia.

Eligible Conditions
  • Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MTD/RP2D of MLN9708 with combination with consolidation chemotherapy
MTD/recommended phase 2 dose (RP2D) of MLN9708 in combination with induction chemotherapy
Secondary outcome measures
Disease Free Survival (DFS)
Dose Limiting Toxicities of MLN9708
Overall Survival (OS)
+2 more

Side effects data

From 2018 Phase 1 & 2 trial • 16 Patients • NCT02057640
50%
Nausea
42%
Diarrhea
33%
Platelet count decreased
33%
anemia
33%
Lymphocyte count decreased
33%
Insomnia
25%
fatigue
25%
Neutrophil count decreased
25%
vomiting
25%
White blood cell decreased
17%
Lung Infection
17%
anorexia
17%
constipation
17%
Hemoglobinuria
17%
Hypohosphatemia
17%
fever
17%
Hypokalemia
17%
creatinine increased
17%
irritability
17%
dizziness
17%
tremors
17%
headache
17%
abdominal pain
8%
Breast infection
8%
Lymphocyte count increased
8%
edema face
8%
Atrial Fibrillation
8%
Muscle weakness lower limb
8%
dyspepsia
8%
Belching
8%
bruising
8%
Hypomagnesemia
8%
Dysgeusia
8%
Postnasal drip
8%
Shingles
8%
Rash maculo-papular
8%
Hyperglycemia
8%
Hypalbuminemia
8%
Hypocalcemia
8%
Taste changes
8%
Edema Limbs
8%
Pain
8%
Gastric hemorrhage
8%
Skin Infection
8%
Depression
8%
blurred vision
8%
Bronchial infection
8%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
DL2 - 4mg Lxazomib
DL1 - 3mg Lxazomib

Trial Design

1Treatment groups
Experimental Treatment
Group I: MLN9708Experimental Treatment3 Interventions
Phase I dose escalation study of MLN9708 with induction chemotherapy MLN9708 -oral on predetermined days per cycle Cytarabine, continuous infusion for predetermined duration and dosage Daunorubicin short IV infusion or rapid injection for predetermined Phase I dose escalation study of MLN9708 with consolidation chemotherapy after establishment of MTD with induction
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daunorubicin
FDA approved
Cytarabine
FDA approved
Ixazomib
FDA approved

Find a Location

Who is running the clinical trial?

Millennium Pharmaceuticals, Inc.Industry Sponsor
404 Previous Clinical Trials
46,875 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,934 Previous Clinical Trials
13,198,542 Total Patients Enrolled
Philip C Amrein, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
36 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
MLN 9708 in Induction and Consolidation for Adults With AML >= 60 Years of Age
Philip C. Amrein, M.D. 2016. "MLN 9708 in Induction and Consolidation for Adults With AML >= 60 Years of Age". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02582359.
~4 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top