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

NCT ID: NCT02027064

Last Updated: 2016-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2017-10-31

Brief Summary

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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)

Detailed Description

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Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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interferon

Group Type EXPERIMENTAL

Interferon-alpha

Intervention Type DRUG

Interventions

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Interferon-alpha

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiaojun Huang

director of Peking University People's Hospital, institute of hematology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking University People's Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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yu wang, M.D.

Role: CONTACT

861088326666 ext. 4952

Facility Contacts

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yu wang, M.D.

Role: primary

861088326666 ext. 4952

References

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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.

Reference Type DERIVED
PMID: 35154096 (View on PubMed)

Mo 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.

Reference Type DERIVED
PMID: 30076280 (View on PubMed)

Other Identifiers

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PUPH IRB [2013](38)

Identifier Type: -

Identifier Source: org_study_id

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