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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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: June 25, 2014
Last verified: June 2014
  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: Allogeneic transplant
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:


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: August 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Without LSC, standard cytarabine consolidation
Drug: Cytarabine consolidation
Cytarabine-based consolidation per institutional standards.
Other Name: HiDAC
Experimental: Arm 2
LSC present, randomized to cytarabine consolidation
Drug: Cytarabine consolidation
Cytarabine-based consolidation per institutional standards.
Other Name: HiDAC
Experimental: Arm 3
LSC present, randomized to allogeneic transplant
Drug: Allogeneic transplant
Allogeneic stem cell transplant per institutional standards.
Other Names:
  • Bone marrow transplant
  • Stem cell transplant
  • Hematopoietic stem cell transplant
  • BMT
  • HSCT

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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+
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588951

Contacts
Contact: Margaret Showel, MD (410) 614-7059 mshowel1@jhmi.edu
Contact: Noah Tucker 410-614-7833 ntucker5@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: June 25, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
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 September 16, 2014