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

Johns Hopkins Medicine

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Allogeneic transplant; Drug: Cytarabine consolidation

Study type: Interventional

Funder types: Other

Identifiers

NCT01588951

J1227

NA_00071844 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 10 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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+

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

No Leukemia Stem Cells - Consolidation

Experimental group

Description:

Without LSC, standard cytarabine consolidation

Treatment:

Drug: Cytarabine consolidation

Leukemia Stem Cells - Consolidation

Experimental group

Description:

LSC present, randomized to cytarabine consolidation

Treatment:

Drug: Cytarabine consolidation

Leukemia Stem Cells - Transplant

Experimental group

Description:

LSC present, randomized to allogeneic transplant

Treatment:

Drug: Allogeneic transplant