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A Phase II Study of 5-Azacitidine (5AC) in Combination With Sargramostim (GM-CSF) as Maintenance Treatment, After Definitive Therapy With Either Stem Cell Transplant (SCT) or Cytarabine-based Chemotherapy, in Patients With Poor-risk Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)


Phase 2
6 Months
N/A
Open (Enrolling)
Both
Acute Myeloid Leukemia, Myelodysplastic Syndrome

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Trial Information

A Phase II Study of 5-Azacitidine (5AC) in Combination With Sargramostim (GM-CSF) as Maintenance Treatment, After Definitive Therapy With Either Stem Cell Transplant (SCT) or Cytarabine-based Chemotherapy, in Patients With Poor-risk Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the 2 year relapse free survival of patients

Outcome Description:

to evaluate the two-year relapse-free survival (RFS) of patients with poor-risk Acute Myeloid Leukemia (AML) or Myelodysplasia (MDS), who receive maintenance treatment with 5-Azacytidine(5AC) in combination with GM-CSF during remission, following definitive therapy with either a stem cell transplant (SCT) or cytarabine-based consolidation chemotherapy.

Outcome Time Frame:

2 year

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

J1240

NCT ID:

NCT01700673

Start Date:

June 2013

Completion Date:

October 2017

Related Keywords:

  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
  • maintenance treatment
  • stem cell transplant
  • cytarabine-based chemotherapy
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

The Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231