Overview

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

Status:
Completed

Trial end date:
2020-06-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborator:

National Cancer Institute (NCI)

Treatments:

Azacitidine
Cytarabine
Sargramostim

Criteria

Inclusion Criteria:

1. Age > 6 months

2. Initial diagnosis of poor -risk AML or MDS (defined in section 3.2), treated with
either stem cell transplant or cytarabine-based consolidation chemotherapy, within the
past 60-185 days

3. ECOG performance status 0-2

4. No morphologic evidence of leukemia or active MDS as determined by JHH
Hematopathologist independent review of a bone marrow aspirate and biopsy done
following the completion of therapy and within 14 days prior to enrollment

5. Peripheral blood count recovery: Neutrophil count ≥ 1000 /µL, platelet count ≥ 50x 109
/µL without platelet transfusions, and adequate hematocrit independent of red cell
transfusions .

6. No evidence of extramedullary leukemia, such as CNS or soft tissue involvement

7. Adequate end organ function as measured by the following: AST and ALT < 4 x normal,
total serum bilirubin < 2 x upper limit normal (unless due to hemolysis, Gilbert's
syndrome, or ineffective erythropoiesis), creatinine < 2 x upper limit of normal

8. Ability to give informed consent

9. In agreement to use an effective barrier method of birth control to avoid pregnancy
during the study and for a minimum of 30 days after study treatment, for all male and
female patients who are fertile

Exclusion Criteria:

1. Patients with untreated or uncontrolled infections

2. Patients with untreated or uncontrolled grade 3 or 4 GVHD

3. Pregnancy and lactation

4. Concurrent use of any other investigational agents.

5. Known HIV-positive patients.

6. Known hypersensitivity to 5AC or GM-CSF