Study Stopped
Low accrual
Consolidation Therapy for Acute Myeloid Leukemia Guided by Leukemia Stem Cell Behavior
2 other identifiers
interventional
10
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2013
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2012
CompletedFirst Posted
Study publicly available on registry
May 1, 2012
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedResults Posted
Study results publicly available
June 5, 2017
CompletedAugust 14, 2018
July 1, 2018
3.3 years
April 27, 2012
May 1, 2017
July 17, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Relapse Free Survival
Percentage of participants alive and without relapsed disease at two years.
2 years
Study Arms (3)
No Leukemia Stem Cells - Consolidation
EXPERIMENTALWithout LSC, standard cytarabine consolidation
Leukemia Stem Cells - Consolidation
EXPERIMENTALLSC present, randomized to cytarabine consolidation
Leukemia Stem Cells - Transplant
EXPERIMENTALLSC present, randomized to allogeneic transplant
Interventions
Cytarabine-based consolidation per institutional standards.
Allogeneic stem cell transplant per institutional standards.
Eligibility Criteria
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+
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Margaret Showel, MD
- Organization
- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Officials
- STUDY CHAIR
Margaret Showel, MD
JHU
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2012
First Posted
May 1, 2012
Study Start
December 1, 2013
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
August 14, 2018
Results First Posted
June 5, 2017
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share