Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Interferon for the Intervention of Molecular Relapse in t (8; 21) AML After Allo-HSCT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02027064
Recruitment Status : Unknown
Verified September 2016 by Xiaojun Huang, Peking University People's Hospital.
Recruitment status was:  Recruiting
First Posted : January 3, 2014
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Xiaojun Huang, Peking University People's Hospital

Brief Summary:

molecular relapse in t (8; 21) acute myeloid leukemia (AML) after allogeneic stem cell transplantation (allo-SCT) is still a problem even after donor lymphocyte infusion.

Interferon seemed to augment graft-versus-leukemia (GVL) effect in this part of patients.

the study is to evaluate the safety and efficacy of interferon for the intervention of molecular relapse in t (8; 21) acute myeloid leukemia (AML) after allogeneic stem cell transplantation (allo-SCT)


Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Interferon-alpha Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2013
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017


Arm Intervention/treatment
Experimental: interferon Drug: Interferon-alpha



Primary Outcome Measures :
  1. relapse rate [ Time Frame: participants will be followed for an expected average of 365 days ]
    number of participants with morphologic relapse at one year



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • high risk t (8; 21) AML
  • molecular relapse after allo-SCT

Exclusion Criteria:

  • active graft-versus-host disease
  • uncontrolled severe infection
  • organ function failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02027064


Contacts
Layout table for location contacts
Contact: yu wang, M.D. 861088326666 ext 4952 ywyw3172@sina.com

Locations
Layout table for location information
China
Peking University People's Hospital Recruiting
Beijing, China, 100044
Contact: yu wang, M.D.    861088326666 ext 4952    ywyw3172@sina.com   
Principal Investigator: xiao-jun huang, M.D.         
Sponsors and Collaborators
Peking University People's Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Xiaojun Huang, director of Peking University People's Hospital, institute of hematology, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT02027064     History of Changes
Other Study ID Numbers: PUPH IRB [2013](38)
First Posted: January 3, 2014    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Interferons
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs