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

NCT05084027 | Unknown Phase 2 DMC

• 1 other identifier: ZJU-HSCT-RIC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 8

Brief Summary

venetoclax combining with fludarabine and melphalan as conditioning regimen prior to allogeneic hematopoietic stem cell transplantation for older patients with hematologic malignancies

Conditions

Hematologic Malignancy; Older Patients; Allogeneic Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• disease free survival

  2-year DFS

  2 year

Secondary Outcomes (4)

• incidence of toxic reaction

  2 year

• overall survival

  2 year

• cumulative incidence of relapse

  2 year

• incidence of acute and or chronic graft verus host disease

  2 year

Study Arms (1)

treatment group

EXPERIMENTAL

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

Combination Product: venetoclax combining with fludarabine and melphalan

Interventions

venetoclax combining with fludarabine and melphalan COMBINATION_PRODUCT

Venetoclax 400mg/day，oral，day-8～day-2; Fludarabine, 30mg/m2/day，intravenous，d-7～d-3；Melphalan, 140mg/ m2/d，intravenous，day-2

treatment group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Sir Run Run Shaw Hospital: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• Zhejiang Provincial People's Hospital: collaborator
• The Affiliated People's Hospital of Ningbo University: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• Ningbo Hospital of Zhejiang University: collaborator
• The First Affiliated Hospital of Zhejiang Chinese Medical University: collaborator

Study Sites (8)

The first Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

First Affiliated Hospital of Zhejiang Chinese Medicine University

Hangzhou, Zhejiang, China

RECRUITING

Second Affiliated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University

Hangzhou, China

RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, China

RECRUITING

Ningbo Hospital of Zhejiang University

Ningbo, China

RECRUITING

The Affiliated People's Hospital of Ningbo University

Ningbo, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

fludarabine; Melphalan

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Yi Luo, M.D.

  First Affilaated Hospital of Medical School of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Luo, M.D.

CONTACT

+86057187233801; luoyijr@163.com

Yibo Wu, M.D.

CONTACT

+8619858876273; wuyibo7@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 19, 2021
• Study Start: October 7, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2024
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)