NCT04809181

Brief Summary

In patients with MRD-positive patients after AML/MDS allogeneic hematopoietic stem cell transplantation, azacytidine combined with venetoclax may be effective in eliminating micro residual diseases, reducing the risk of relapse, and ultimately improving long-term survival.The primary purpose of this study was to explore an effective protocol to reduce the risk of relapse in patients with MRD positive after allogeneic hematopoietic stem cell transplantation for AML/MDS.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
95

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2021

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

March 19, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

March 19, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 22, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2026

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

3 years

First QC Date

March 19, 2021

Last Update Submit

February 19, 2023

Conditions

Hematologic MalignancyStem Cell Transplant Complications

Keywords

Allogeneic Hematopoietic stem cell transplantationMicro residual diseaseAzacitidineVenetoclaxRelapse

Outcome Measures

Primary Outcomes (1)

  • relapse-free survival

    relapse-free survival

    2 year

Secondary Outcomes (4)

  • overall survival

    2 year

  • graft-versus-host disease -free relapse-free survival

    2 year

  • cumulative incidence of aGVHD

    100 days

  • cumulative incidence of cGVHD

    2 year

Study Arms (1)

MRD positive AML/MDS patients after allogeneic hematopoietic stem cell transplantation

EXPERIMENTAL

MRD positive AML/MDS patients after allogeneic hematopoietic stem cell transplantation

Drug: Azacitidine in Combination With Venetoclax

Interventions

Azacitidine in Combination With VenetoclaxDRUG

Azacitidine in combination with venetoclax

MRD positive AML/MDS patients after allogeneic hematopoietic stem cell transplantation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between 18 years old and 65 years old.
  • Patients with AML or MDS diagnosed according to WHO diagnostic criteria.
  • Patients who received allogeneic hematopoietic stem cell transplantation and achieved complete remission.
  • MRD was positive after transplantation, MFC \> 0.1% and / or fusion gene and gene mutation (WT1 \> 0.6%, AML1-ETO \> 0.4%, others \>1%).
  • ECOG body status score 0-2.
  • Patients with expected survival time \>=3 months.
  • Good organ function level: ANC (neutrophil absolute value \>=1.0x10\^9/L; PLT \>=30x10\^9/L; HB \>=80g/L; Tibil \<=1.5 ULN; ALT / AST \<=2.5 ULN; bun / Cr \<=1.5 ULN; LVEF \>=50%).
  • Patients who have received any anti-tumor treatment (including radiotherapy, chemotherapy, surgery or molecular targeted treatment) for more than 4 weeks from the end of the previous treatment.
  • Patients with no GVHD and no previous history of 3 or more degrees of aGVHD. 10. Patients who voluntarily participate in the clinical trial, understand the research procedure and can sign the informed consent in writing.

You may not qualify if:

  • Patients with severe cardiac insufficiency and EF lower than 60%; or patients with severe arrhythmia who could not tolerate super pretreatment.
  • Patients with activity of aGVHD or extensive cGVHD.
  • Patients with BCR/ABL positive.
  • Patients who were previously known to be resistant to azacytidine or dessicabine or venetoclax.
  • In patients with severe pulmonary insufficiency (obstructive and / or restrictive ventilation disorders), the researchers evaluated the patients who could not tolerate the super pretreatment scheme.
  • Patients with severe liver function impairment and liver function indexes (alt, TBIL) more than 3 ULN were evaluated as intolerant of super pretreatment.
  • In patients with severe renal insufficiency, the renal function index (CR) is more than 2 times of the upper limit of the normal value (ULN), or the 24-hour creatinine clearance rate (CR) is less than 50ml / min, the researchers evaluated that they could not tolerate the super pretreatment scheme.
  • In patients with severe active infection, the researchers evaluated that they could not tolerate the pretreatment.
  • Patients who had allergic reactions or serious adverse reactions in the previous use of pretreatment related drugs could not be included in the study.
  • Patients with hematological recurrence (bone marrow smear: proportion of primordial cells \>=5%) or any extramedullary recurrence.
  • Other reasons why the researchers could not be selected.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Hematologic NeoplasmsRecurrence

Interventions

Azacitidinevenetoclax

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Yi Luo, M.D.

    First Affilaated Hospital of Medical School of Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Luo, M.D.

CONTACT

+86057187233801luoyijr@163.com

Yibo Wu, M.D.

CONTACT

+8619858876273wuyibo7@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 19, 2021

First Posted

March 22, 2021

Study Start

March 19, 2021

Primary Completion

March 19, 2024

Study Completion

March 19, 2026

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)