Consolidation Therapy for Acute Myeloid Leukemia Guided by Leukemia Stem Cell Behavior
Conditions
Acute Myeloid Leukemia
Conditions: official terms
Leukemia - Leukemia, Myeloid - Leukemia, Myeloid, Acute
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Cytarabine consolidation Type: Drug
Name: Allogeneic transplant Type: Drug
Overall Status
Recruiting
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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+
Location
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Status: Recruiting
Start Date
August 2013
Completion Date
June 2017
Sponsors
Sidney Kimmel Comprehensive Cancer Center
Source
Sidney Kimmel Comprehensive Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page