Allogeneic Hematopoietic Stem Cell Transplantation, Hematologic Malignancy, Older Patients
Conditions
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.
Interventions
COMBINATION_PRODUCTvenetoclax 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
Sponsors
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
First Affiliated Hospital of Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease free survival | 2 year | 2-year DFS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of toxic reaction | 2 year | 2-year incidence of toxic reaction |
| overall survival | 2 year | 2-year OS |
| cumulative incidence of relapse | 2 year | 2-year incidence of relapse |
| incidence of acute and or chronic graft verus host disease | 2 year | 2-year incidence of cGVHD |
Countries
China
Contacts
Primary ContactYi Luo, M.D.
Backup ContactYibo Wu, M.D.
Outcome results
None listed