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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01588951
• Other study ID #: J1227
• Secondary ID: NA_00071844
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: December 2013
• Est. completion date: April 2017

Study information

• Verified date: July 2018
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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 ß- HCG+

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Cytarabine consolidation
Cytarabine-based consolidation per institutional standards.
• Allogeneic transplant
Allogeneic stem cell transplant per institutional standards.

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse Free Survival	Percentage of participants alive and without relapsed disease at two years.	2 years