Clinical trial
Cladribine With Intermediate Cytarabine, G-CSF and VP16 Sequential With Fludarabine and Busulifan as Condoning Regimen for Refractory Acute Leukemia
Name
RJH-Ref-AL-2018
Description
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.
Trial arms
Trial start
2018-08-01
Estimated PCD
2021-08-30
Trial end
2022-12-30
Status
Completed
Phase
Early phase I
Treatment
CLAGE-FluBu
Cladribine combined with cytarabine and VP16 sequential with Fludarabine combined with busulifan
Arms:
treatment
Size
18
Primary endpoint
leukemia-free survival
1 year
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 18, 'type': 'ACTUAL'}}
Updated at
2023-08-15
1 organization
1 product
2 indications
Organization
Shanghai Jiao Tong University School of MedicineProduct
CLAGE-FluBuIndication
Hematologic CancerIndication
Allogeneic Stem Cell Transplantation