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

Primary Purpose

HSCT, Efficacy and Safety

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Azacitidine combined with interferon preemptive treatment

About this trial

This is an interventional treatment trial for HSCT focused on measuring azacitidine, HSCT, interferon, safety, Efficacy

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Patients enrolled must meet the following criteria:

≥ 14 years old, male or female;
Patients with allogeneic peripheral blood stem cell transplantation due to myeloid tumors of the blood system (AML/MDS/CML/MPN, etc.);
Recurrence trend evaluation criteria: the proportion of bone marrow blast cells <5%; flow cell MRD ≥ 0.01% and interval 2 consecutive times 2 times; fusion gene interval 2 weeks at least 2 consecutive positive and rising trend or from negative to positive; Bone marrow WT1 levels increased dynamically and were greater than 0.6%; chimeric rate (STR) decreased by >5% (STR <90%) or XY-FISH donor chimerism decreased by >0.5%;
Blood routine: neutrophils>0.5×109/L, platelets>25.0×109/L;
There is no active grade II or higher acute GVHD or moderate or severe chronic GVHD;
Liver and kidney function: liver function (AST/ALT/TB) <5 times normal upper limit; renal function (Cr) < 2 times normal upper limit;
The patient must be able to understand and be willing to participate in the study and sign an informed consent form.

Exclusion criteria:

Possible subjects who meet any of the following criteria will be excluded from the trial:

Recurrence after transplantation;
Patients who have not achieved complete remission after transplantation;
Implantation failed;
Pregnant or lactating women;
Have received other interventions or are receiving other research drugs before the study begins;
Patient blood routine: ANC <0.5 × 109 / L or PLT < 25 × 109 / L;
There are active uncontrolled infections: hemodynamic instability associated with infection, or new signs or signs of infection, or new infections in imaging, persistent fever with asympto or signs cannot be ruled out Infected person
People infected with HIV;
Active hepatitis B (HBV), active hepatitis C (HCV) requires antiviral therapy; patients with HBV activation risk refer to patients with hepatitis B surface antigen positive or core antibody positive patients who do not receive anti-HBV treatment;
Those who are allergic to known azacitidine or interferon;
At the discretion of the investigator, other dangerous complications may result.

Sites / Locations

Xianmin SongRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients with recurrence after allogeneic transplantat

Arm Description

One arm

Outcomes

Primary Outcome Measures

Treatment response rate

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04078399

First Posted

August 28, 2019

Last Updated

October 24, 2020

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT04078399

Brief Title

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

Official Title

Efficacy and Safety of Azacitidine Combined With Interferon in the Treatment of Recurrence of Allogeneic Hematopoietic Stem Cell Transplantation in Myeloid Tumors of the Blood System

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 28, 2019 (Actual)

Primary Completion Date

August 28, 2022 (Anticipated)

Study Completion Date

August 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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: 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; 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HSCT, Efficacy and Safety

Keywords

azacitidine, HSCT, interferon, safety, Efficacy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

patients with recurrence after allogeneic transplantat

Arm Type

Experimental

Arm Description

One arm

Intervention Type

Drug

Intervention Name(s)

Azacitidine combined with interferon preemptive treatment

Intervention Description

Azacitidine combined with interferon preemptive therapy for prevention and treatment of recurrence of allogeneic transplantation of myeloid tumors (AML/MDS/MPN) in the blood system

Primary Outcome Measure Information:

Title

Treatment response rate

Description

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

Time Frame

6months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Patients enrolled must meet the following criteria: ≥ 14 years old, male or female; Patients with allogeneic peripheral blood stem cell transplantation due to myeloid tumors of the blood system (AML/MDS/CML/MPN, etc.); Recurrence trend evaluation criteria: the proportion of bone marrow blast cells <5%; flow cell MRD ≥ 0.01% and interval 2 consecutive times 2 times; fusion gene interval 2 weeks at least 2 consecutive positive and rising trend or from negative to positive; Bone marrow WT1 levels increased dynamically and were greater than 0.6%; chimeric rate (STR) decreased by >5% (STR <90%) or XY-FISH donor chimerism decreased by >0.5%; Blood routine: neutrophils>0.5×109/L, platelets>25.0×109/L; There is no active grade II or higher acute GVHD or moderate or severe chronic GVHD; Liver and kidney function: liver function (AST/ALT/TB) <5 times normal upper limit; renal function (Cr) < 2 times normal upper limit; The patient must be able to understand and be willing to participate in the study and sign an informed consent form. Exclusion criteria: Possible subjects who meet any of the following criteria will be excluded from the trial: Recurrence after transplantation; Patients who have not achieved complete remission after transplantation; Implantation failed; Pregnant or lactating women; Have received other interventions or are receiving other research drugs before the study begins; Patient blood routine: ANC <0.5 × 109 / L or PLT < 25 × 109 / L; There are active uncontrolled infections: hemodynamic instability associated with infection, or new signs or signs of infection, or new infections in imaging, persistent fever with asympto or signs cannot be ruled out Infected person People infected with HIV; Active hepatitis B (HBV), active hepatitis C (HCV) requires antiviral therapy; patients with HBV activation risk refer to patients with hepatitis B surface antigen positive or core antibody positive patients who do not receive anti-HBV treatment; Those who are allergic to known azacitidine or interferon; At the discretion of the investigator, other dangerous complications may result.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xianmin Song, M.D

Phone

021-63240090

shongxm@139.com

First Name & Middle Initial & Last Name or Official Title & Degree

Hongliang Fang, doctor

Phone

021-58552006

fanghongliang@dashengbio.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xianmin Song, M.D

Organizational Affiliation

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xianmin Song

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200080

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xianmin Song, Doctor

Phone

86-21-63240090

Ext

3932

shongxm@sjtu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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