Efficacy and Safety of Azacitidine Combined With Interferon in the Treatment of Post-transplant Recurrence

Not Applicable

• Conditions: Efficacy and Safety; HSCT
• Interventions: Drug: Azacitidine combined with interferon preemptive treatment

• Registration Number: NCT04078399
• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

This study is a single-center, one-arm, prospective, phase II clinical trial with the primary objective of assessing the effectiveness of azacitidine combined with interferon in the prevention of recurrence after allogeneic transplantation of myeloid tumors (AML/MDS/MPN) in the blood system. Sex and safety.

At the screening/baseline period, informed consent is obtained and the inclusion/exclusion criteria are checked. Plan to enroll 30 patients, and collect demographic data, medical history data, vital signs, physical examination, laboratory tests (hematuria, liver and kidney function; immune indicators: T cell subsets, Treg, etc.), pregnancy test for female patients And other necessary auxiliary inspections.

The time to start treatment is: a decrease in chimerism and/or minimal residual disease (MRD) after myeloid tumor allogeneic hematopoietic stem cell transplantation.

Detailed Description

Treatment programs:

1. Basic protocol: Azacitidine is administered subcutaneously at 32 mg/m2/d for 5 consecutive days; α-interferon treatment started on day 8 for 3 weeks; 4-6 weeks/treatment with long-acting interferon Gebin). 1-1.5 million U / kg, once a week; or ordinary alpha-interferon, 200 acres / square meter / d (total ≥ 300MU / d), 5-7 days a week;

2. Start time of medication:

1 In the absence of immunosuppressive agents such as cyclosporine, the chimeric rate is decreased and/or MRD-positive: or in the case of immunosuppressive agents such as cyclosporine, the chimeric rate is fully chimeric and MRD-positive: A-interferon is first administered. Single-agent intervention, if there was no significant decrease in MRD for 2 consecutive courses (MRD decreased ≤ 50%), azacitidine combined with interferon intervention was started; 2 In the case of calmodulin immunosuppressant (cyclosporine or tacrolimus), the chimeric rate decreased and the MRD was negative, the immunosuppressant was rapidly reduced or discontinued, and the bone marrow was reviewed 2 weeks, if the chimeric rate did not rise. (decreased or stable), or after two consecutive immunosuppressive adjustments did not reach complete chimerism, start azacitidine combined with interferon intervention; (3) If cyclosporine or other immunosuppressive agents are applied before the start of the study, rapid reduction; dose reduction 1 / 4-1 / 2; if the chimeric rate increases or GVHD occurs, continue the immunosuppressant adjustment strategy; (4) Stop treatment: acute GVHD above II degree; patients are intolerant to the study protocol; basic regimen is ineffective after 2 courses of treatment (chimeric rate continues to decline or MRD continues to increase) or disease recurrence; transplant.

Study Timeline

• Study Start: 2019-08-28
• Study First Submitted: 2019-08-28
• Study First Submitted QC: 2019-09-01
• Study First Posted: 2019-09-06
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-24
• Last Update Posted: 2020-10-27
• Primary Completion: 2022-08-28
• Study Completion: 2022-08-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with recurrence after allogeneic transplantat	Azacitidine combined with interferon preemptive treatment	One arm

Primary Outcome Measures

Name	Time	Method
Treatment response rate	6months	Treatment response rate after 6 months of pretreatment with azacitidine combined with interferon (primary response + secondary response)

Trial Locations

Locations (1)

Xianmin Song; 🇨🇳 Shanghai, Shanghai, China