Interferon for the Intervention of Molecular Relapse in t (8; 21) AML After Allo-HSCT
1 other identifier
interventional
40
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2013
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 2, 2014
CompletedFirst Posted
Study publicly available on registry
January 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedSeptember 29, 2016
September 1, 2016
4 years
January 2, 2014
September 27, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
relapse rate
number of participants with morphologic relapse at one year
participants will be followed for an expected average of 365 days
Study Arms (1)
interferon
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- high risk t (8; 21) AML
- molecular relapse after allo-SCT
You may not qualify if:
- active graft-versus-host disease
- uncontrolled severe infection
- organ function failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University People's Hospital
Beijing, 100044, China
Related Publications (2)
Shen MZ, Zhang XH, Xu LP, Wang Y, Yan CH, Chen H, Chen YH, Han W, Wang FR, Wang JZ, Zhao XS, Qin YZ, Chang YJ, Liu KY, Huang XJ, Mo XD. Preemptive Interferon-alpha Therapy Could Protect Against Relapse and Improve Survival of Acute Myeloid Leukemia Patients After Allogeneic Hematopoietic Stem Cell Transplantation: Long-Term Results of Two Registry Studies. Front Immunol. 2022 Jan 28;13:757002. doi: 10.3389/fimmu.2022.757002. eCollection 2022.
PMID: 35154096DERIVEDMo XD, Wang Y, Zhang XH, Xu LP, Yan CH, Chen H, Chen YH, Qin YZ, Liu KY, Huang XJ. Interferon-alpha Is Effective for Treatment of Minimal Residual Disease in Patients with t(8;21) Acute Myeloid Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation: Results of a Prospective Registry Study. Oncologist. 2018 Nov;23(11):1349-1357. doi: 10.1634/theoncologist.2017-0692. Epub 2018 Aug 3.
PMID: 30076280DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- director of Peking University People's Hospital, institute of hematology
Study Record Dates
First Submitted
January 2, 2014
First Posted
January 3, 2014
Study Start
October 1, 2013
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
September 29, 2016
Record last verified: 2016-09