Leukemia Clinical Trial
Official title:
An Open-Label, One-Arm, Multi-Site Trial of Precision Diagnosis Directing Histone Deacetylase Inhibitor Chidamide Total Therapy for Adult T-lymphoblastic Lymphoma/Leukemia
Based on the pediatric-inspired, PEG-L-asparaginase-intensified and MRD-directed PDT-ALL-2016 protocol, this open-label, one-arm, multi-site trial PDT-ALL-LBL is aimed to evaluate the safety and effect of oral histone deacetylase inhibitor chidamide for adult T-ALL/LBL. Compared to PDT-ALL-2016 for B-ALL, HDACi chidamide will be administrated from induction therapy to maintenance therapy, along with higher dose of consolidation regimen of cytarabine, methotrexate, cyclophosphamide.
T-lymphoblastic lymphoma/leukemia is a neoplasm of lymphoblasts committed to the T-cell
lineage, typically composed of small to medium-sized blast with scant cytoplasm, moderately
condensed to dispersed chromatin, and inconspicuous nucleoli, involving bone marrow and blood
or presenting with primary involvement of the thymus or of nodal or extranodal sites.
T-ALL/LBL is generally considered a higher-risk disease than B-ALL. Compared to B-ALL,
T-LBL/ALL is associated with a higher risk of induction failure, early relapse, and isolated
CNS relapse.
Chidamide is a novel oral HDACi with promising activity in non-Hodgkin lymphoma (NHL).
Chidamide, a new oral isotype-selective HDACi, approved in China for the treatment of R/R
PTCL in December 2014. 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-ALL-LBL is
aimed to evaluate the safety and effect of oral histone deacetylase inhibitor chidamide for
adult T-ALL/LBL. Compared to PDT-ALL-2016 for B-ALL, HDACi chidamide will be administrated
from induction therapy to maintenance therapy, along with higher dose of consolidation
regimen of cytarabine, methotrexate, cyclophosphamide.
The intervention of PDT-ALL-LBL consists of diagnostic test (bone marrow aspiration, flow
immunophenotyping, karyotyping，FISH, NGS, Flow-MRD), induction regimen (chidamide,
dexamethasone, vincristine, cyclophosphamide, Idarubicin, pegaspargase), consolidation
regimen (chidamide, prednisone, cytarabine, methotrexate, cyclophosphamide, etoposide,
adriamycin, 6-mercaptopurine, pegaspargase), MRD assessment (MRD1/d14, MRD2/d24, MRD3/d45,
MRD4/pre-allo-HSCT) and maintenance regimen (chidamide, vincristine, methotrexate,
6-mercaptopurine), intrathecal injection, radiation therapy (for mediastinum- and/or central
nervous system-involved lymphoma/leukemia) and allogeneic hematopoietic stem cell
transplantation for patients with donor.
Induction Regimen-Pretreatment: dexamethasone, -3d to 0d; Induction regimen VICLD: VCR: d1,
d8, d15, d22; IDA: d1, d8; CTX: 1g/m2, 1; PEG-asp: 2000-2500IU/m2, 1, 15; dexamethasone:
1-24; chidamide: 10mg/d, po, qd. Flow-based MRD assessment: d14, d24 during induction
regimen, d45, and pre-HSCT. Salvage regimen VLCAM (MRD1/d24>1%): CTX, d25; AraC 50mg/m2,
d25-31; 6-MP: 25-31, PEG-asp: 2500IU/m2, d26. Consolidation Module (CM)-CM1: AraC 3g/m2,
q12h, d1-2, Dex: 10mg/m2, d1-2, PEG-asp: 2, 6-MP: d1-7, chidamide, po qd; CM2: MTX 5g/m2, 1,
Dex: 10mg/m2, 1-2, PEG-asp: d2, 6-MP: 1-7, chidamide, po qd; CM3: CTX 1g/m2, 1-3, PEG-asp: 2,
6-MP: 1-7, chidamide, po qd. CM4-6: repeat CM 1-3. Re-Induction: VICLD after CM6. CM7-9:
repeat CM1-3. Allo-HSCT: after CM3 when matched-related-donor (MRD), haploidentical related
donor (HRD) or matched-unrelated-donor (MUD) available. Non-allo-HSCT: finish CM4-9 and CPOMP
maintenance. Maintenance Module-CPOMP: chidamide, po qd for 24 months; Pred: for 12 months;
VCR for 12 months; MTX: for 24m months; 6-MP for 24 months.
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