ClinicalTrials.Veeva

Menu

Study of Brentuximab Vedotin Combined With RCHOP or RCHP in Front-line Treatment of Patients With Diffuse Large B-cell Lymphoma (DLBCL)

Seagen logo

Seagen

Status and phase

Terminated
Phase 2

Conditions

Lymphoma, B-cell
Lymphoma, Large B-cell, Diffuse

Treatments

Drug: rituximab
Drug: doxorubicin
Drug: brentuximab vedotin
Drug: vincristine
Drug: cyclophosphamide
Drug: prednisone

Study type

Interventional

Funder types

Industry

Identifiers

NCT01925612
SGN35-017

Details and patient eligibility

About

This study has 3 parts. The purpose of Part 1 of this study is to assess the safety and efficacy of brentuximab vedotin in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) (known as BV+RCHOP) in patients with DLBCL who have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive RCHOP together with 1 of 2 doses of brentuximab vedotin. Patients will be tested to see if there is a difference in side effects between the 2 groups.

The purpose of Part 2 of this study is to assess the safety and efficacy of brentuximab vedotin in combination with RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) (known as BV+RCHP) in patients with CD30-positive DLBCL who have never been treated. Patients will be enrolled to receive RCHP together with 1.8mg/kg of brentuximab vedotin.

The purpose of Part 3 of this study is to assess the safety and efficacy of BV+RCHP compared to standard RCHOP in patients with CD30-positive DLBCL that have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive either BV+RCHP or RCHOP. Patients will be tested to see if there is a difference in side effects between the 2 groups.

Full description

In the first part of this study, patients in the 2 groups were tested to see if there was a difference in the response to treatment and whether there were differences in the side effects (unwanted effects).

The second and third parts of the study are being done to see if there are any side effects (unwanted effects) of the higher dose of brentuximab vedotin when combined with a modified version of RCHOP that omits vincristine. The third part of the study is being done to see if there is a difference between BV+RCHP and RCHOP in the response to treatment.

Enrollment

87 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Treatment-naive patients with systemic de novo or transformed diffuse large B cell lymphoma (DLBCL) or follicular non-Hodgkin lymphoma (NHL) grade 3b
  • International Prognostic Index (IPI) score greater than or equal to 3 for patients greater than 60 years of age or age-adjusted IPI (aaIPI) score of 2 or 3 for patients less than or equal to 60 years of age
  • Stage IAX (bulk defined as single lymph node mass >10 cm in diameter), IB-IV disease
  • Measurable disease of at least 1.5 cm
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
  • Patients in Parts 2 and 3 must have histologically confirmed diagnosis of CD30-positive DLBCL

Exclusion criteria

  • Previous history of treated indolent lymphoma
  • History of another primary malignancy that has not been in remission for 3 years

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

87 participants in 5 patient groups

Part 1: BV(1.2 mg/kg) + RCHOP
Experimental group
Description:
Brentuximab vedotin 1.2 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone Part 1 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin when administered in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). Patients in this arm were randomized into the 1.2 mg/kg brentuximab vedotin dosing cohort, to be administered in combination with RCHOP.
Treatment:
Drug: vincristine
Drug: prednisone
Drug: doxorubicin
Drug: brentuximab vedotin
Drug: rituximab
Drug: cyclophosphamide
Drug: brentuximab vedotin
Part 1: BV(1.8 mg/kg) + RCHOP
Experimental group
Description:
Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone Part 1 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin when administered in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). Patients in this arm were randomized into the 1.8 mg/kg brentuximab vedotin dosing cohort, to be administered in combination with RCHOP.
Treatment:
Drug: vincristine
Drug: prednisone
Drug: doxorubicin
Drug: brentuximab vedotin
Drug: rituximab
Drug: cyclophosphamide
Drug: brentuximab vedotin
Part 2: BV(1.8 mg/kg) + RCHP
Experimental group
Description:
Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone Part 2 of the study is a phase 2, non-randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin 1.8 mg/kg when administered in combination with RCHP chemotherapy (rituximab, cyclophosphamide, doxorubicin, and prednisone). Patients in this treatment arm were enrolled into a dosing cohort with 1.8 mg/kg brentuximab vedotin administered in combination with RCHP.
Treatment:
Drug: prednisone
Drug: doxorubicin
Drug: brentuximab vedotin
Drug: rituximab
Drug: cyclophosphamide
Drug: brentuximab vedotin
Part 3: RCHOP
Active Comparator group
Description:
Rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone Part 3 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin 1.8 mg/kg when administered in combination with RCHP chemotherapy compared to RCHOP chemotherapy alone. Patients in this treatment arm were randomized to receive RCHOP treatment alone.
Treatment:
Drug: vincristine
Drug: prednisone
Drug: doxorubicin
Drug: rituximab
Drug: cyclophosphamide
Part 3: BV(1.8 mg/kg) + RCHP
Experimental group
Description:
Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone Part 3 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin 1.8 mg/kg when administered in combination with RCHP chemotherapy compared to RCHOP chemotherapy alone. Patients in this treatment arm were randomized to receive RCHOP treatment alone. Randomization in this part of the study is for the purpose of evaluating the safety of 1.8 mg/kg brentuximab vedotin in combination with RCHP versus standard RCHOP chemotherapy. Part 3 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin 1.8 mg/kg when administered in combination with RCHP chemotherapy compared to RCHOP chemotherapy alone. Patients in this treatment arm were randomized to receive 1.8 mg/kg brentuximab vedotin administered in combination with RCHP.
Treatment:
Drug: prednisone
Drug: doxorubicin
Drug: brentuximab vedotin
Drug: rituximab
Drug: cyclophosphamide
Drug: brentuximab vedotin

Trial documents
2

Trial contacts and locations

51

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems