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

Sun Yat-sen University logo

Sun Yat-sen University

Status and phase

Unknown
Phase 2

Conditions

Lymphoma, Large B-Cell, Diffuse

Treatments

Drug: gemcitabine, vinorelbine and doxorubicin liposome, with or without rituximab

Study type

Interventional

Funder types

Other

Identifiers

NCT04021992
B2019-088

Details and patient eligibility

About

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.

Enrollment

48 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • biopsy proved CD20+ DLBCL;
  • previously received at least one systemic treatment (including chemotherapy) without remission or relapse after remission;
  • at least one evaluable lesion;
  • ECOG PS 0-1;
  • 18-65 years;
  • proper functioning of the major organs.

Exclusion criteria

  • involvement of central nervous system;
  • with other malignancy;
  • patients receiving or received drug of other clinical trial within 30 days;
  • previously received doxorubicin liposome or have used other anthracycline drug with accumulated restricted doses (adriamycin 450mg/m2, epirubicin 935mg/m2, acrarubicin 900mg/m2);
  • patients who received treatment for hematologic toxicity caused by previous chemotherapy within 7 days before enrollment;
  • grade 2 or more peripheral neuropathy.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

48 participants in 1 patient group

GVD with or without R
Experimental group
Description:
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.
Treatment:
Drug: gemcitabine, vinorelbine and doxorubicin liposome, with or without rituximab

Trial contacts and locations

1

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Central trial contact

Qingqing Cai, MD

Data sourced from clinicaltrials.gov

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