Consolidation Therapy for Acute Myeloid Leukemia Guided by Leukemia Stem Cell Behavior

• Status: Terminated
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the trial is to compare the two-year relapse-free survival (RFS) of patients with acute myeloid leukemia (AML), presumed to be at high risk for relapse due to the presence of leukemia stem cells (LSCs) in their bone marrow at first complete remission (CR1), who receive either standard cytarabine-based chemotherapy or allogeneic stem cell transplantation (SCT).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Treatments: Cytarabine

Criteria

Inclusion Criteria:

1. Age greater than or equal to 18 years

2. Able to give informed consent

3. New diagnosis of AML, other than APL or poor-risk AML, as defined in section 3.2

Exclusion criteria:

1. Has already had a bone marrow biopsy and aspirate to assess remission status after induction therapy

2. Any debilitating medical or psychiatric illness that would preclude ability to give informed consent or receive optimal treatment and follow-up

3. Pregnancy: Women of childbearing potential who are β- HCG+