Know Cancer

or
forgot password

Azacitidine Compared to Conventional Chemotherapy in Consolidation of Elderly Patients (65 Years or Older) With AML in First Complete Remission


Phase 2
65 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia

Thank you

Trial Information

Azacitidine Compared to Conventional Chemotherapy in Consolidation of Elderly Patients (65 Years or Older) With AML in First Complete Remission


Inclusion Criteria:



1. Subjects >65 years of age at the time of signing the informed consent form

2. A confirmed diagnosis of AML according to the 2008 WHO classification

- This includes: Bone marrow aspirate with a good clot or biopsy for morphology,
flow cytometry, cytogenetic analysis, and in case of normal cytogenetics,
molecular genetic analyses including FLT3-ITD, NPM-1 and CEBP A

- Bio-banking of leukemic cells at diagnosis performed (according to guidelines of
the Swedish National AML biobank).

3. A documented CR or CRp achieved after one or two induction courses.

Exclusion Criteria:

1. Subjects who are not considered to be candidates to complete the consolidation
therapy due to medical or psychological reasons.

2. Subjects who have taken any investigational drugs or participated in an
interventional clinical trial within 30 days prior to screening.

3. Patients with acute promyelocytic leukemia

4. Patients with t(8;21) or inv(16)

5. CNS leukemia

6. Patients with a previous diagnosis of MDS, i.e. AML preceded by a diagnosed MDS

7. Subjects who are candidates for allogeneic stem cell transplantation (SCT)

8. Another cancer diagnosis with a life expectancy of less than two years

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Leukemia free survival

Outcome Time Frame:

One year

Safety Issue:

No

Principal Investigator

Per Bernell, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Karolinska University Hospital

Authority:

Sweden: Medical Products Agency

Study ID:

SWEAML12-a

NCT ID:

NCT01794169

Start Date:

March 2013

Completion Date:

March 2018

Related Keywords:

  • Acute Myeloid Leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location