Venetoclax-containing Therapy Combined With Microtransplant for Intermediate-risk and Higher MDS

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing 302 Hospital

About this trial

This study aims to evaluate the safety and efficacy of a Venetoclax and hypomethylating agent-based regimen combined with infusion of HLA-mismatched donor G-CSF mobilized peripheral blood mononuclear cells (GPBMC) in patients with intermediate-risk and higher myelodysplastic syndromes who are ineligible for allogeneic hematopoietic stem cell transplantation.

Eligibility criteria

Qualifiers

Age >=18 years, male or female, non-limited by race or ethnicity.

Confirmed diagnosis of MDS according to the World Health Organization (WHO) 5th edition classification, based on histopathology and cytogenetics.

Risk stratification according to the Revised International Prognostic Scoring System (IPSS-R) must place the patient in the intermediate-, high-, or very high-risk category.

Not candidates for or refuse allogeneic hematopoietic stem cell transplantation.

Disqualifiers

Uncontrolled infection or hemorrhage.

Cardiovascular disease with clinical significance, such as uncontrolled or highly symptomatic cardiac arrhythmias, congestive heart failure, or myocardial infarction within 6 months prior to screening, or New York Heart Association (NYHA) function class 3 (moderate) or class 4 (severe) heart disease.

Uncontrolled autoimmune disease or requiring immunosuppression treatment.

History of severe blood infusion reaction.

Trial design

Treatments tested in this trial

  • Venetoclax
  • Azacitidine (AZA) or Decitabine (DAC)
  • GPBMC infusion

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators