MedTrace Logo

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

NCT03837873 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2022-01-26

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

Rituximab

rituximab 750mg/m2 i.v. on day 0

DRUG

Etoposide

50mg/m2, continuous i.v. on day 1-4

DRUG

Vincristine

0.4mg/m2, continuous i.v. on day 1-4

DRUG

Doxorubicin

10mg/m2, continuous i.v. on day 1-4

DRUG

Dexamethasone

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

DRUG

Cyclophosphamide

750mg/m2, i.v. on day5

DRUG

Lenalidomide

25mg/day, p.o. on day 0-9

DRUG

Cisplatin

100mg/m2 continuous i.v. on day 1

DRUG

Cytarabine

2g/m2 q12h, i.v. on day 2

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Principal Investigators

  • Dehui Zou, Dr. · Institute of Hematology & Blood Diseases Hospital, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-21
Primary Completion
2023-09-01
Completion
2024-09-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03837873 on ClinicalTrials.gov