Clinical trial · Interventional
CLAGE Sequential With Flu-Bu Conditioning for Refractory Acute Leukemia
Cladribine With Intermediate Cytarabine, G-CSF and VP16 Sequential With Fludarabine and Busulifan as Condoning Regimen for Refractory Acute Leukemia
- 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)
For patients with refractory acute leukemia, allogeneic stem cell transplantation is the only curative therapy. Only 20% of patients may achieve long-term survival mostly due to relapse or nor-relapse mortality (NRM). In previous study, we demonstrated that intensive leukemia debulking chemotherapy FLAG-IDA sequential with Flu-BU conditioning is feasible with \~40% long-term survival. In the study, we further modified the chemotherapy with cladribine replacing fludarabine aiming a more potent anti-leukemia effect. Meanwhile, we reduce the dose of busulfan for patients with poor performance status and age over 45 aim to reduce the NRM. All patients will also receive post-transplantation maintenance therapy with low-dose decitabine to prevent relapse.
Conditions
Conditions (2)
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 Stem Cell Transplantation | — | UNRESOLVED | — |
| Refractory Hematologic Cancer | Hematopoietic and Lymphoid Cell Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CLAGE-FluBu | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment
- description
- Patients receive the study protocol: CLAGE sequential with Flu-Bu as conditioning regimen followed by low-dose decitabine maintenance
- interventionNames
- Drug: CLAGE-FluBu
Primary outcomes (1)
- measure
- leukemia-free survival
- timeFrame
- 1 year
- description
- From enrollment to any event as relapse or death
Secondary outcomes (3)
- measure
- overall survival
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * refractory myeloid malignancies including acute myeloid leukemia (AML) or chronic myeloid leukemia in blastic crisis (CML-BC) * HLA matched sibling，unrelated donor, or haplo-identical donor * Patients with bone marrow blast \>5% and positive measurable disease via flowcytometry or PCR. Exclusion Criteria: * patients with active infection * liver function damage: ALT/AST above 2X normal range; and renal function damage Scr\>160µmol/L; insufficient pulmonary function (FEV1，FVC，DLCO\<50%）and heart failure or with EF \<50% * mental instability * unwilling to give inform consent
References
Publications (0)
Data not yet available