Clinical trial NCT05084027: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hematologic Malignancy
Older Patients
Allogeneic Hematopoietic Stem Cell Transplantation
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
Collaborators: name: Sir Run Run Shaw Hospital
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Zhejiang Provincial People's Hospital
name: The Affiliated People's Hospital of Ningbo University
name: First Affiliated Hospital of Wenzhou Medical University
name: Ningbo Hospital of Zhejiang University
name: The First Affiliated Hospital of Zhejiang Chinese Medical University
First posted: 2021-10-19
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: disease free survival
timeFrame: 2 year
Secondary outcomes:
measure: incidence of toxic reaction
timeFrame: 2 year
measure: overall survival
timeFrame: 2 year
measure: cumulative incidence of relapse
timeFrame: 2 year
measure: incidence of acute and or chronic graft verus host disease
timeFrame: 2 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The first Affiliated Hospital of Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: First Affiliated Hospital of Zhejiang Chinese Medicine University
state: Zhejiang
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University, School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
city: Ningbo
country: China
facility: Ningbo Hospital of Zhejiang University
city: Ningbo
country: China
facility: The Affiliated People's Hospital of Ningbo University
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
Study officials:
affiliation: First Affilaated Hospital of Medical School of Zhejiang University
name: Yi Luo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: