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Venetoclax Combining With Fludarabine and Melphalan as Conditioning Regimen for Allo-HSCT

Primary Purpose

Hematologic Malignancy, Older Patients, Allogeneic Hematopoietic Stem Cell Transplantation

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
venetoclax combining with fludarabine and melphalan
Sponsored by
First Affiliated Hospital of Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematologic Malignancy

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age older than 50 years
  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:

  1. Patients who didn't achieved complete remission before transplantation (bone marrow smear: proportion of primordial cells >=5%) or any extramedullary recurrence.
  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.

Sites / Locations

  • The first Affiliated Hospital of Zhejiang UniversityRecruiting
  • First Affiliated Hospital of Zhejiang Chinese Medicine UniversityRecruiting
  • Second Affiliated Hospital of Zhejiang University, School of MedicineRecruiting
  • Sir Run Run Shaw Hospital, College of Medicine, Zhejiang UniversityRecruiting
  • Zhejiang Provincial People's HospitalRecruiting
  • Ningbo Hospital of Zhejiang UniversityRecruiting
  • The Affiliated People's Hospital of Ningbo UniversityRecruiting
  • The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment group

Arm Description

older patients accepting venetoclax combining with fludarabine and melphalan as conditioning regimen prior to allogeneic hematopoietic stem cell transplantation treatment

Outcomes

Primary Outcome Measures

disease free survival
2-year DFS

Secondary Outcome Measures

incidence of toxic reaction
2-year incidence of toxic reaction
overall survival
2-year OS
cumulative incidence of relapse
2-year incidence of relapse
incidence of acute and or chronic graft verus host disease
2-year incidence of cGVHD

Full Information

First Posted
October 7, 2021
Last Updated
October 20, 2021
Sponsor
First Affiliated Hospital of Zhejiang University
Collaborators
Sir Run Run Shaw Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Zhejiang Provincial People's Hospital, The Affiliated People's Hospital of Ningbo University, First Affiliated Hospital of Wenzhou Medical University, Ningbo Hospital of Zhejiang University, The First Affiliated Hospital of Zhejiang Chinese Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05084027
Brief Title
Venetoclax Combining With Fludarabine and Melphalan as Conditioning Regimen for Allo-HSCT
Official Title
Venetoclax Combining With Fludarabine and Melphalan as Conditioning Regimen Prior to Allogeneic Hematopoietic Stem Cell Transplantation for Older Patients With Hematologic Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Zhejiang University
Collaborators
Sir Run Run Shaw Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Zhejiang Provincial People's Hospital, The Affiliated People's Hospital of Ningbo University, First Affiliated Hospital of Wenzhou Medical University, Ningbo Hospital of Zhejiang University, The First Affiliated Hospital of Zhejiang Chinese Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
venetoclax combining with fludarabine and melphalan as conditioning regimen prior to allogeneic hematopoietic stem cell transplantation for older patients with hematologic malignancies
Detailed Description
It was a phase Ⅱ clinical trial of new designed reduced-intensity conditioning regimen for older patients accepting allogeneic hematopoietic stem cell transplantation treatment. The regimen consisted of venetoclax combining with fludarabine and melphalan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancy, Older Patients, Allogeneic Hematopoietic Stem Cell Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment group
Arm Type
Experimental
Arm Description
older patients accepting venetoclax combining with fludarabine and melphalan as conditioning regimen prior to allogeneic hematopoietic stem cell transplantation treatment
Intervention Type
Combination Product
Intervention Name(s)
venetoclax combining with fludarabine and melphalan
Intervention Description
Venetoclax 400mg/day，oral，day-8～day-2; Fludarabine, 30mg/m2/day，intravenous，d-7～d-3；Melphalan, 140mg/ m2/d，intravenous，day-2
Primary Outcome Measure Information:
Title
disease free survival
Description
2-year DFS
Time Frame
2 year
Secondary Outcome Measure Information:
Title
incidence of toxic reaction
Description
2-year incidence of toxic reaction
Time Frame
2 year
Title
overall survival
Description
2-year OS
Time Frame
2 year
Title
cumulative incidence of relapse
Description
2-year incidence of relapse
Time Frame
2 year
Title
incidence of acute and or chronic graft verus host disease
Description
2-year incidence of cGVHD
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age older than 50 years Patients diagnosed with acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome according to WHO diagnostic criteria. Patients who achieved complete remission before transplantation. Patients who have alternative donors and plane to accept allogeneic hematopoietic stem cell transplantation treatment. ECOG body status score 0-2. 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 voluntarily participate in the clinical trial, understand the research procedure and can sign the informed consent in writing. Exclusion Criteria: Patients who didn't achieved complete remission before transplantation (bone marrow smear: proportion of primordial cells >=5%) or any extramedullary recurrence. Patients who were previously known to be resistant to 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. Other reasons why the researchers could not be selected.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Luo, M.D.
Phone
+86057187233801
Email
luoyijr@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yibo Wu, M.D.
Phone
+8619858876273
Email
wuyibo7@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Luo, M.D.
Organizational Affiliation
First Affilaated Hospital of Medical School of Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The first Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Luo, M.D.
Phone
+86057187233801
Email
luoyijr@163.com
Facility Name
First Affiliated Hospital of Zhejiang Chinese Medicine University
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baodong Ye, MD
Phone
+8657187236706
Email
13588453501@qq.com
Facility Name
Second Affiliated Hospital of Zhejiang University, School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Xu, MD
Phone
+8657187236706
Email
zjuyujian@126.com
Facility Name
Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haowen Xiao, MD
Phone
+86057187236706
Email
xiaohaowen@zju.edu.cn
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianping Lan, MD
Phone
+8657187236706
Email
lanjp@163.com
Facility Name
Ningbo Hospital of Zhejiang University
City
Ningbo
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guifang Ouyang, MD
Phone
+86057187233801
Email
luoyijr@163.com
Facility Name
The Affiliated People's Hospital of Ningbo University
City
Ningbo
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Lu, MD
Phone
+86057187236706
Email
luying741107@qq.com
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Chen, MD
Phone
+8657187236706
Email
chenyi19527@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Venetoclax Combining With Fludarabine and Melphalan as Conditioning Regimen for Allo-HSCT

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