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

Hematologic Malignancy Clinical Trial

Official title:

Venetoclax Combining With Fludarabine and Melphalan as Conditioning Regimen Prior to Allogeneic Hematopoietic Stem Cell Transplantation for Older Patients With Hematologic Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05084027
• Other study ID #: ZJU-HSCT-RIC
• Status: Recruiting
• Phase: Phase 2
• Start date: October 7, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: October 2021
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Yi Luo, M.D.
• Phone: +86057187233801
• Email: luoyijr[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allogeneic Hematopoietic Stem Cell Transplantation
• Hematologic Malignancy
• Hematologic Neoplasms
• Neoplasms
• Older Patients

Intervention

Combination Product:
• 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

Locations

Country	Name	City	State
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	The first Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang
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

Sponsors (8)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University	First Affiliated Hospital of Wenzhou Medical University, Ningbo Hospital of Zhejiang University, Second Affiliated Hospital, School of Medicine, Zhejiang University, Sir Run Run Shaw Hospital, The affiliated people's hospital of Ningbo University, The First Affiliated Hospital of Zhejiang Chinese Medical University, Zhejiang Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease free survival	2-year DFS	2 year
Secondary	incidence of toxic reaction	2-year incidence of toxic reaction	2 year
Secondary	overall survival	2-year OS	2 year
Secondary	cumulative incidence of relapse	2-year incidence of relapse	2 year
Secondary	incidence of acute and or chronic graft verus host disease	2-year incidence of cGVHD	2 year