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

Phase 2

Terminated

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: Cytarabine consolidation; Drug: Allogeneic transplant

• Registration Number: NCT01588951
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-27
• Study First Submitted QC: 2012-04-30
• Study First Posted: 2012-05-01
• Study Start: 2013-12
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Results First Submitted: 2017-05-01
• Results First Submitted QC: 2017-05-01
• Results First Posted: 2017-06-05
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-08-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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+

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Leukemia Stem Cells - Consolidation	Cytarabine consolidation	Without LSC, standard cytarabine consolidation
Leukemia Stem Cells - Consolidation	Cytarabine consolidation	LSC present, randomized to cytarabine consolidation
Leukemia Stem Cells - Transplant	Allogeneic transplant	LSC present, randomized to allogeneic transplant

Primary Outcome Measures

Name	Time	Method
Relapse Free Survival	2 years	Percentage of participants alive and without relapsed disease at two years.

Trial Locations

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States