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Trial Title:
Venetoclax Plus RIC Regimen Allo-HSCT for Elderly Patients With High-risk Myeloid Malignancies
NCT ID:
NCT05583175
Condition:
Leukemia, Myeloid, Acute
MDS
Hematopoietic Stem Cell Transplantation
Myeloid Malignancy
Conditions: Official terms:
Neoplasms
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Venetoclax
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Venetoclax plus RIC
Description:
Eligible patients will receive Venetoclax plus RIC regimen allogeneic transplantation.
The treatment regimen is: Venetoclax 100mg/d - 10d, 200mg/d - 9d (first use and NR or
untreated MDS), 400mg/d, - 8d~ - 2d (7d); Fludarabine: 30mg/m2/d, - 6d~-2d (5d),
Cytarabine: 1g/m2/d, - 6d~-2d (5d) Busulfan: 3.2mg/m2/d, - 6d~-5d (2d), TBI: 3 Gray, -
1d.
Arm group label:
Venetoclax plus RIC
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.
Detailed description:
Eligible patients will receive Venetoclax plus RIC regimen allogeneic transplantation.
The treatment regimen is: Venetoclax 100mg/d - 10d, 200mg/d - 9d (first use and NR or
untreated MDS), 400mg/d, - 8d~ - 2d (7d); Fludarabine: 30mg/m2/d, - 6d~-2d (5d),
Cytarabine: 1g/m2/d, - 6d~-2d (5d) Busulfan: 3.2mg/m2/d, - 6d~-5d (2d), total body
irradiation(TBI): 3 Gray, - 1d.
Primary end point: 1 year and 2 year progression free survival (PFS) after
transplantation. Secondary end point: incidence of acute GVHD within 180 days after
transplantation; cumulative rate of relapse, overall survival(OS), graft-versus-host
disease (GVHD)-free relapse-free survival(GRFS), non-relapse mortality(NRM), and
incidence of chronic GVHD at 1 and 2 years after transplantation; The reactivation rate
of cytomegalovirus(CMV) and Epstein-Barr virus (EBV) within 1 year after transplantation.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. ≥ 55 years old;
2. 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.
3. 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:
1. Creatinine≤1.5×ULN;
2. Left ventricular ejection fraction >50%;
3. Baseline oxygen saturation>92%;
4. Total bilirubin≤1.5×ULN；ALT and AST≤2.0×ULN；
5. DLCO≥ 40% and FEV1 ≥ 50%。 7. Able to understand and sign the Informed Consent
Document.
Exclusion Criteria:
1. Patients with Venetoclax ineffectiveness;
2. Malignant tumors other than acute myeloid leukemia within 5 years prior to
screening, in addition to adequately treated cervical carcinoma in situ, basal cell
or squamous cell skin cancer, localized prostate cancer after radical resection, and
ductal carcinoma in situ after radical resection；
3. ECOG socre>2;
4. HCT-CI score> 4。
5. Any instability of systemic disease, including but not limited to unstable angina,
cerebrovascular accident, or transient cerebral ischemic (within 3 months prior to
screening), myocardial infarction (within 3 months prior to screening), congestive
heart failure (New York heart association (NYHA) classification ≥ III), need drug
therapy of severe arrhythmia, liver, kidney, or metabolic disease; patients with
pulmonary hypertension
6. Uncontrolled infection during screening period; Hemodynamic instability associated
with infection,a new infection or aggravation of the original infection;new lesions
on imaging;fever of unknown cause;
7. Patients with symptoms of central nervous system;greater than grade 2 requiring
treatment,paralysis,aphasia,acute cerebral infarction,severe traumatic brain
injury,schizophrenia;
8. HIV infection;
9. Patients with active hepatitis B virus (HBV) and active hepatitis C virus (HCV) need
antiviral treatment; Patients at risk of HBV activation refer to patients with
positive HBsAg or HBeAb but not receiving anti-HBV treatment;
10. History of autoimmune disease；
11. Pregnant or lactating women；
12. Fertile men and women who are unwilling to use contraceptive technology during the
treatment period and within 12 months after treatment.
Gender:
All
Minimum age:
55 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai General Hospital
Address:
City:
Shanghai
Zip:
200080
Country:
China
Status:
Recruiting
Contact:
Last name:
Xianmin Song, M.D.
Phone:
86-21-63240090
Phone ext:
3172
Email:
shongxm@sjtu.edu.cn
Start date:
November 1, 2022
Completion date:
November 1, 2024
Lead sponsor:
Agency:
Xianmin Song, MD
Agency class:
Other
Source:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05583175
