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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02027064
Other study ID # PUPH IRB [2013](38)
Secondary ID
Status Recruiting
Phase Phase 4
First received January 2, 2014
Last updated September 27, 2016
Start date October 2013
Est. completion date October 2017

Study information

Verified date September 2016
Source Peking University People's Hospital
Contact yu wang, M.D.
Phone 861088326666
Email ywyw3172@sina.com
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date October 2017
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender Both
Age group N/A to 65 Years
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Interferon-alpha


Locations

Country Name City State
China Peking University People's Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary relapse rate number of participants with morphologic relapse at one year participants will be followed for an expected average of 365 days No
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