Clinical trial · Interventional
Venetoclax Combining With Fludarabine and Melphalan as Conditioning Regimen for Allo-HSCT
Venetoclax Combining With Fludarabine and Melphalan as Conditioning Regimen Prior to Allogeneic Hematopoietic Stem Cell Transplantation for Older Patients With Hematologic Malignancies
NCT05084027CI-TRIAL-00054691unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
venetoclax combining with fludarabine and melphalan as conditioning regimen prior to allogeneic hematopoietic stem cell transplantation for older patients with hematologic malignancies
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Allogeneic Hematopoietic Stem Cell Transplantation | — | UNRESOLVED | — |
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Older Patients | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| venetoclax combining with fludarabine and melphalan | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment group
- description
- older patients accepting venetoclax combining with fludarabine and melphalan as conditioning regimen prior to allogeneic hematopoietic stem cell transplantation treatment
- interventionNames
- Combination Product: venetoclax combining with fludarabine and melphalan
Primary outcomes (1)
- measure
- disease free survival
- timeFrame
- 2 year
- description
- 2-year DFS
Secondary outcomes (4)
- measure
- incidence of toxic reaction
- timeFrame
- 2 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLai X, Zhu P, Yang L, Liu L, Wu Y, Shi J, Yu J, Zhao Y, Ouyang G, Chen Y, Ye Y, Zhang P, Sun L, Zheng W, Sun J, Huang H, Luo Y. Integration of venetoclax into a fludarabine and melphalan conditioning regimen in patients aged 50 years and older with acute myeloid leukemia and myelodysplastic syndrome: Results from a phase 2 clinical trial. Cancer. 2026 Jun 1;132(11):e70467. doi: 10.1002/cncr.70467. PMID 42159161