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Safety and Clinical Activity Study of Combination Azacitidine and Avelumab in Patients With Acute Myeloid Leukemia (AML) and Minimal Residual Disease (MRD)

NCT03699384 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2019-02-20

No results posted yet for this study

Summary

This is a phase I / II study. The purposes of this study are to: 1) find out what effects, good and/or bad, the combination of the experimental drug avelumab and the drug azacitidine has on people with AML and MRD, and 2) test if the two drugs, avelumab and azacitidine, are effective in getting rid of AML MRD when the drugs are given together in combination.

Conditions

  • Acute Myeloid Leukemia (AML)
  • Minimal Residual Disease

Interventions

DRUG

Azacitidine

AZA 75 mg/m\^2 SC or IV D 1-7 28 day cycle x 1

DRUG

Avelumab

Avelumab 10mg/kg IV D1, D15, 28d cycle Until progression or MRD If MRD-, tx x 1 yr or go to allo SCT

Sponsors & Collaborators

Principal Investigators

  • Aaron Goldberg, MD, PhD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-03
Primary Completion
2019-02-18
Completion
2019-02-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03699384 on ClinicalTrials.gov