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

This study is not yet open for participant recruitment.
Verified September 2012 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01588951
First received: April 27, 2012
Last updated: May 15, 2013
Last verified: September 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Acute Myeloid Leukemia
 Drug: Cytarabine consolidation
Drug: Cytarabine vs BMT
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Consolidation Therapy for Acute Myeloid Leukemia Guided by Leukemia Stem Cell Behavior

Resource links provided by NLM:

Drug Information available for: Cytarabine
U.S. FDA Resources

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Relapse free survival [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm1
Without LSC, standard cytarabine consolidation
 Drug: Cytarabine consolidation
Cytarabine based consolidation per institutional standard
Experimental: Arm 2
LSC present, Randomized to standard cytarabine
 Drug: Cytarabine vs BMT
standard cytarabine-based consolidation therapy or allogeneic SCT, per institutional standards.
Experimental: Arm 3
With LSC randomized to BMT
 Drug: Cytarabine vs BMT
standard cytarabine-based consolidation therapy or allogeneic SCT, per institutional standards.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 years to 75 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, that has been treated with induction therapy in the last four weeks
  4. ECOG performance status of 0 or 1 -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588951

Contacts
Contact: Margaret Showel, MD (410) 614-3803 mshowel1@jhmi.edu
Contact: Jackie Greer, RN 410-614-1329 jgreer6@jhmi.edu

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01588951     History of Changes
Other Study ID Numbers: J1227, NA_00071844
Study First Received: April 27, 2012
Last Updated: May 15, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013