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

Stopped early · Phase 2/Phase 3

Conditions studied: Acute Myeloid Leukemia

In brief

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).

Key facts

Study ID

NCT01588951

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

10

Starts

2013-12-01

Expected to finish

2017-04-01

Last updated by the study team

2018-08-14

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age greater than or equal to 18 years
• Able to give informed consent
• New diagnosis of AML, other than APL or poor-risk AML, as defined in section 3.2

You may not qualify if…

• Has already had a bone marrow biopsy and aspirate to assess remission status after induction therapy
• Any debilitating medical or psychiatric illness that would preclude ability to give informed consent or receive optimal treatment and follow-up
• Pregnancy: Women of childbearing potential who are β- HCG+

Where it is running

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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