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

July 17, 2018 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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+

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No Leukemia Stem Cells - Consolidation
Without LSC, standard cytarabine consolidation
Drug: Cytarabine consolidation
Cytarabine-based consolidation per institutional standards.
Other Names:
  • HiDAC
Experimental: Leukemia Stem Cells - Consolidation
LSC present, randomized to cytarabine consolidation
Drug: Cytarabine consolidation
Cytarabine-based consolidation per institutional standards.
Other Names:
  • HiDAC
Experimental: Leukemia Stem Cells - Transplant
LSC present, randomized to allogeneic transplant
Drug: Allogeneic transplant
Allogeneic stem cell transplant per institutional standards.
Other Names:
  • HSCT
  • BMT
  • Bone marrow transplant
  • Stem cell transplant
  • Hematopoietic stem cell transplant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse Free Survival
Time Frame: 2 years
Percentage of participants alive and without relapsed disease at two years.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Investigators

  • Study Chair: Margaret Showel, MD, JHU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2013

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

April 27, 2012

First Submitted That Met QC Criteria

April 30, 2012

First Posted (Estimate)

May 1, 2012

Study Record Updates

Last Update Posted (Actual)

August 14, 2018

Last Update Submitted That Met QC Criteria

July 17, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J1227
  • NA_00071844 (Other Identifier: JHMIRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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