DLCL002 Protocol for Patients With High Risk Aggressive B-cell Lymphoma

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT03837873
Phase
PHASE2
Status
Unknown

Conditions

  • Diffuse Large B Cell Lymphoma
  • High-grade B-cell Lymphoma
  • Transformed Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    rituximab 750mg/m2 i.v. on day 0
  • Etoposide — DRUG
    50mg/m2, continuous i.v. on day 1-4
  • Vincristine — DRUG
    0.4mg/m2, continuous i.v. on day 1-4
  • Doxorubicin — DRUG
    10mg/m2, continuous i.v. on day 1-4
  • Dexamethasone — DRUG
    30mg/day, i.v. on day 1-5 for R-DA-EDOCH regimen; 40mg/day, i.v. on day 1-4 for R(2)-DHAP regimen
  • Cyclophosphamide — DRUG
    750mg/m2, i.v. on day5
  • Lenalidomide — DRUG
    25mg/day, p.o. on day 0-9
  • Cisplatin — DRUG
    100mg/m2 continuous i.v. on day 1
  • Cytarabine — DRUG
    2g/m2 q12h, i.v. on day 2

Study Details

Patients eligible for the study will receive R-DA-EDOCH as the induction therapy and be evaluated by PET CT after the fourth cycle. Patients achieve CR at interim-PET(Deauville score 1-3) will receive either ASCT or the remaining 4 cycles of R-DA-EDOCH, while those achieve PR(Deauville score 4-5) will be rescued by two courses of R(2)-DHAP and then be revaluated by the second interim-PET. Patients who achieved CR+good PR(Deauville score 4) after the rescue therapy will be consolidated with ASCT,and those remain in PR(Deauville score 5) will receive other rescue treatments(including ASCT+CAR T).

Key Dates

Start date
Jan 21, 2019
Status verified
Jan 2022
Primary completion
Sep 1, 2023
Completion
Sep 1, 2024

Study Design

Enrollment
118 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: DLCL002 protocol
    Patients will receive R-DA-EDOCH(rituximab, etoposide, dexamethasone, vincristine, cyclophosphamide, doxorubicin) as induction therapy and be evaluated by PET CT after the fourth cycle. Patients achieve CR at interim-PET will receive either ASCT or the remaining 4 cycles of R-DA-EDOCH, while those achieve PR(Deauville score 4-5) will be rescued by two courses of R(2)-DHAP(rituximab, lenalidomide(only for patients with non-GCB DLBCL), dexamethasone, cisplatin, cytarabine). Patients who achieved CR+good PR(Deauville score 4) after the rescue therapy will be consolidated with ASCT,and those remain in PR(Deauville score 5) will receive other rescue treatments.

Primary Outcome Measure

PFS [ Time Frame: From the date of the start of treatment until the date of first documented progression, relapse or death from any cause, whichever came first, assessed up to 2 years. ]

Central Contacts

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