Study of Venetoclax and Reduced-intensity Conditioning Regimen(RIC) for Allogeneic Stem Cell Transplantation(Allo-HSCT) in Elderly Patients With High-risk Myeloid Malignancies

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study is a single center, single arm, prospective, phase II clinical study to evaluate the efficacy and safety of Venatoclax combined with reduced intensity conditioning regimen allo-HSCT in the treatment of high-risk myeloid malignancies in the elderly patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Healthy Volunteers: f
View:

• ≥ 55 years old;

• High risk myeloid malignancies: 1)No hematological remission(NR) after induction/re-induction treatment for AML; 2)Morphological remission but with persistent positive minimal resident disease(MRD) (Flow cytometry\>0.01% and/or fusion gene positive and/or digital polymerase chain reaction(PCR) positive); 3)High risk acute myeloid leukemia(AML) according to 2022 European Leukemia Net(ELN) risk stratification; 4)High risk myelodysplastic syndrome(MDS): IPSS-R score ≥ middle risk-2; therapy-related MDS; MDS with mutation of ASXL1, EZH2, RUNX1, SRSF2, U2AF1, STAG2, NRAS, ZRSR2, or TP53; 5)High risk chronic myelomonocytic leukemia(CMML), MDS/MPN.

• Patients must have appropriate donor:

⁃ 1)Related donor must be HLA-A, - B, - C, - DQB1 and - DRB1 matched at least 5/10; 2)Unrelated donor must be HLA-A, - B, - C, - DQB1 and - DRB1 matched at least 8/10; 4. Hematopoietic cell transplantation-comorbidity Index(HCT-CI) score ≤ 4。 5. Eastern Cooperative Oncology Group(ECOG) score 0-2。 6. Liver, kidney and cardiopulmonary functions meet the following requirements:

• Creatinine≤1.5×ULN;

• Left ventricular ejection fraction \>50%;

• Baseline oxygen saturation\>92%;

• Total bilirubin≤1.5×ULN;ALT and AST≤2.0×ULN;

• DLCO≥ 40% and FEV1 ≥ 50%。 7. Able to understand and sign the Informed Consent Document.

Locations
Other Locations
China
Shanghai General Hospital
RECRUITING
Shanghai
Contact Information
Primary
Jie Gao
siberia77@qq.com
+86177882248225
Backup
Xianmin Song
shongxm@139.com
+862163240090
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2024-11-01
Participants
Target number of participants: 50
Treatments
Experimental: Venetoclax plus RIC
Administration with oral Venetoclax plus RIC regimen for allo-HSCT in the elderly patients with myeloid malignancies.
Related Therapeutic Areas
Sponsors
Leads: Xianmin Song, MD

This content was sourced from clinicaltrials.gov

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