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Phase II Study of Azacitidine and Sargramostim as Maintenance Treatment for Poor-Risk AML or MDS

NCT01700673 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-10-18

Study results available
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Summary

To determine the impact of maintenance therapy in patients with MDS/AML in remission.

Conditions

Interventions

DRUG

Azacitidine

Azacitidine will be administered days 1-5 of a 28 day cycle. Treatment is planned for a total of 12 cycles.

BIOLOGICAL

Sargramostim

Sargramostim will be administered days 1-10 of a 28 day cycle. Treatment is planned for a total of 12 cycles.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Margaret Showel, MD · JHU

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT01700673 on ClinicalTrials.gov