Precision Diagnosis Directing HDACi and TKI Target Therapy for Adult Ph-like ALL
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- STATUS
- Recruiting
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- End date
- Aug 30, 2023
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- participants needed
- 120
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- sponsor
- Nanfang Hospital of Southern Medical University
Summary
Ph-like ALL is a recently recognized high-risk subgroup and the optimal therapeutic approaches are poorly characterized. Based on the pediatric-inspired, PEG-L-asparaginase-intensified and MRD-directed PDT-ALL-2016 protocol, this open-label, two-arm, multi-site trial PDT-Ph-like-ALL is aimed to evaluate the safety and effect of oral histone deacetylase inhibitor chidamide and dasatinib for adult Ph-like ALL.
Description
Ph-like, or BCR-ABL1-like lymphoblastic leukemia is neoplasm of lymphoblasts committed to the B-cell lineage that lack the BCR-ABL1 translocation but show a pattern of the expression very similar to that seen in BCR-ABL1-positive ALL. Chidamide is a novel oral HDACi with promising activity in non-Hodgkin lymphoma (NHL). Based on the pediatric-inspired, PEG-L-asparaginase-intensified and MRD-directed PDT-ALL-2016 protocol, this open-label, two-arm, multi-site trial is aimed to evaluate the safety and effect of oral histone deacetylase inhibitor (HDACi) chidamide and tyrosine kinase inhibitor (TKI) dasatinib for adult Ph-like ALL/LBL. HDACi chidamide and TKI dasatinib will be added to chidamide and dasatinib group, respectively, from induction therapy to consolidation therapy (total courses of chidamide treatment: 5 courses for allo-HSCT after Consolidation Module-3; 12 courses for patients non-allo-HSCT after Consolidation Module 1-9). Primary study endpoint is event-free survival and secondary study endpoints are complete remission and MRD after induction, adverse event and overall survival.
Pretreatment: Dexamethasone, -3 to 0d;
Chidamide for chidamide arm: 10mg/d, po qd.
Dasatinib for Dasatinib arm: 100mg/d, po qd.
Induction:VCR: 1, 8, 15, 22; IDA: 1, 8; CTX: 1g/m2, 1; PEG-asp: 2000-2500IU/m2, 1, 15; Pred: 1-24;
MRD assessment: d14, 24, 45, and pre-allo-HSCT.
VLCAM (MRD1/d14>1%): CTX, d25; AraC 50mg/m2, d25-31, 26; 6-MP: 25-31, PEG-asp: 26;
Consolidation Module:
CM1: AraC 2g/m2, q12h, 1-2, Dex: 10mg/m2, 1-2, PEG-asp: 2, 6-MP: 1-7. IT: d1; CM2: MTX 3g/m2, 1, Dex: 10mg/m2, 1-2, PEG-asp: 2; 6-MP: 1-7; IT: d1; CM3: CTX 0.5g/m2, 1-3, PEG-asp: 2, 6-MP: 1-7, IT: d1.
Allo-HSCT: after CM3 when donors available. Non-HSCT: finish CM 4-9 and POMP maintenance.
CM4-6: repeat CM1-3. Re-Induction: after CM6. CM7-9: repeat CM1-3.
Maintenance: POMP-Pred: x12m; VCR x12m; MTX: x24m; 6-MPx24m.
Details
| Condition | Leukemia, Leukemia, Acute, Leukemia, Lymphoblastic, Leukemia, B-cell |
|---|---|
| Treatment | dasatinib, Chidamide |
| Clinical Study Identifier | NCT03564470 |
| Sponsor | Nanfang Hospital of Southern Medical University |
| Last Modified on | 4 October 2022 |
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