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

NCT04078399 | Unknown DMC

• 1 other identifier: SHSYXY- aza-relapse-2019002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

HSCT; Efficacy and Safety

Keywords

azacitidine; HSCT; interferon; safety; Efficacy

Outcome Measures

Primary Outcomes (1)

• Treatment response rate

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

  6months

Study Arms (1)

patients with recurrence after allogeneic transplantat

EXPERIMENTAL

One arm

Drug: Azacitidine combined with interferon preemptive treatment

Interventions

Azacitidine combined with interferon preemptive treatment DRUG

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

patients with recurrence after allogeneic transplantat

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xianmin Song

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

Study Officials

• Xianmin Song, M.D

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xianmin Song, M.D

CONTACT

021-63240090; shongxm@139.com

Hongliang Fang, doctor

CONTACT

021-58552006; fanghongliang@dashengbio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 6, 2019
• Study Start: August 28, 2019
• Primary Completion: August 28, 2022
• Study Completion: August 28, 2022
• Last Updated: October 27, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)