Back to resultsConsolidation Therapy for Acute Myeloid Leukemia Guided by Leukemia Stem Cell Behavior
Primary Purpose
Acute Myeloid Leukemia
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cytarabine consolidation
Allogeneic transplant
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion criteria:
- 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+
Sites / Locations
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
No Leukemia Stem Cells - Consolidation
Leukemia Stem Cells - Consolidation
Leukemia Stem Cells - Transplant
Arm Description
Without LSC, standard cytarabine consolidation
LSC present, randomized to cytarabine consolidation
LSC present, randomized to allogeneic transplant
Outcomes
Primary Outcome Measures
Relapse Free Survival
Percentage of participants alive and without relapsed disease at two years.
Secondary Outcome Measures
Full Information
NCT ID
NCT01588951
First Posted
April 27, 2012
Last Updated
July 17, 2018
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1. Study Identification
Unique Protocol Identification Number
NCT01588951
Brief Title
Consolidation Therapy for Acute Myeloid Leukemia Guided by Leukemia Stem Cell Behavior
Official Title
Consolidation Therapy for Acute Myeloid Leukemia Guided by Leukemia Stem Cell Behavior
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Low accrual
Study Start Date
December 2013 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Leukemia Stem Cells - Consolidation
Arm Type
Experimental
Arm Description
Without LSC, standard cytarabine consolidation
Arm Title
Leukemia Stem Cells - Consolidation
Arm Type
Experimental
Arm Description
LSC present, randomized to cytarabine consolidation
Arm Title
Leukemia Stem Cells - Transplant
Arm Type
Experimental
Arm Description
LSC present, randomized to allogeneic transplant
Intervention Type
Drug
Intervention Name(s)
Cytarabine consolidation
Other Intervention Name(s)
HiDAC
Intervention Description
Cytarabine-based consolidation per institutional standards.
Intervention Type
Drug
Intervention Name(s)
Allogeneic transplant
Other Intervention Name(s)
Bone marrow transplant, Stem cell transplant, Hematopoietic stem cell transplant, BMT, HSCT
Intervention Description
Allogeneic stem cell transplant per institutional standards.
Primary Outcome Measure Information:
Title
Relapse Free Survival
Description
Percentage of participants alive and without relapsed disease at two years.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion criteria:
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+
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Showel, MD
Organizational Affiliation
JHU
Official's Role
Study Chair
Facility Information:
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Consolidation Therapy for Acute Myeloid Leukemia Guided by Leukemia Stem Cell Behavior
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