GVD±R Regimen for ASCT-eligible Patients With Refractory/Relapsed DLBCL

Sponsor
Sun Yat-sen University
Study ID
NCT04021992
Phase
PHASE2
Status
Unknown

Conditions

  • Lymphoma, Large B-Cell, Diffuse

Eligibility Criteria

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

Interventions

Study Details

The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of GVD±R (gemcitabine, oral vinorelbine and doxorubicin liposome, with or without rituximab) regimen for autologous hematopoietic stem cell transplantation(ASCT)-eligible patients with refractory/relapsed diffuse large B-cell lymphoma.

Key Dates

Start date
Jul 15, 2019
Status verified
Aug 2019
Primary completion
Jul 15, 2023
Completion
Dec 15, 2023

Study Design

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

Arms

  • Experimental: GVD with or without R
    Gemcitabine 1000mg/m2, d1,d8, intravenous drip; Vinorelbine 50mg/m2, d1,d8, oral; Doxorubicin liposomes 30mg/m2, d1,intravenous drip; With or without rituximab 375 mg/m2, d0,intravenous drip; All patients received up to 6 treatment cycles of 21 days.

Primary Outcome Measure

ORR [ Time Frame: 4-years ]

Central Contacts

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