Venetoclax Combining With Fludarabine and Melphalan as Conditioning Regimen for Allo-HSCT
NCT ID: NCT05084027
Last Updated: 2021-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2021-10-07
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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treatment group
older patients accepting venetoclax combining with fludarabine and melphalan as conditioning regimen prior to allogeneic hematopoietic stem cell transplantation treatment
venetoclax combining with fludarabine and melphalan
Venetoclax 400mg/day，oral，day-8～day-2; Fludarabine, 30mg/m2/day，intravenous，d-7～d-3；Melphalan, 140mg/ m2/d，intravenous，day-2
Interventions
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venetoclax combining with fludarabine and melphalan
Venetoclax 400mg/day，oral，day-8～day-2; Fludarabine, 30mg/m2/day，intravenous，d-7～d-3；Melphalan, 140mg/ m2/d，intravenous，day-2
Eligibility Criteria
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Inclusion Criteria
2. Patients diagnosed with acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome according to WHO diagnostic criteria.
3. Patients who achieved complete remission before transplantation.
4. Patients who have alternative donors and plane to accept allogeneic hematopoietic stem cell transplantation treatment.
5. ECOG body status score 0-2.
6. 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%).
7. Patients who voluntarily participate in the clinical trial, understand the research procedure and can sign the informed consent in writing.
Exclusion Criteria
2. Patients who were previously known to be resistant to venetoclax.
3. 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.
4. Patients with severe liver function impairment and liver function indexes (alt, TBIL) more than 3 ULN were evaluated as intolerant of super pretreatment.
5. 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.
6. In patients with severe active infection, the researchers evaluated that they could not tolerate the pretreatment.
7. Patients who had allergic reactions or serious adverse reactions in the previous use of pretreatment related drugs could not be included in the study.
8. Other reasons why the researchers could not be selected.
50 Years
80 Years
ALL
No
Sponsors
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Sir Run Run Shaw Hospital
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Zhejiang Provincial People's Hospital
OTHER
The Affiliated People's Hospital of Ningbo University
OTHER_GOV
First Affiliated Hospital of Wenzhou Medical University
OTHER
Ningbo Hospital of Zhejiang University
UNKNOWN
The First Affiliated Hospital of Zhejiang Chinese Medical University
OTHER
First Affiliated Hospital of Zhejiang University
OTHER
Responsible Party
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Yi Luo
Principal Investigator
Principal Investigators
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Yi Luo, M.D.
Role: PRINCIPAL_INVESTIGATOR
First Affilaated Hospital of Medical School of Zhejiang University
Locations
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The first Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
First Affiliated Hospital of Zhejiang Chinese Medicine University
Hangzhou, Zhejiang, China
Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University
Hangzhou, , China
Zhejiang Provincial People's Hospital
Hangzhou, , China
Ningbo Hospital of Zhejiang University
Ningbo, , China
The Affiliated People's Hospital of Ningbo University
Ningbo, , China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Yi Luo, M.D.
Role: primary
Baodong Ye, MD
Role: primary
Yang Xu, MD
Role: primary
Haowen Xiao, MD
Role: primary
Jianping Lan, MD
Role: primary
Guifang Ouyang, MD
Role: primary
Ying Lu, MD
Role: primary
Yi Chen, MD
Role: primary
Other Identifiers
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ZJU-HSCT-RIC
Identifier Type: -
Identifier Source: org_study_id