A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL

Seagen

Status and phase: Terminated; Phase 2

Conditions: Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin

Treatments: Drug: ifosfamide; Drug: placebo; Drug: SGN-40; Drug: carboplatin; Drug: rituximab; Drug: etoposide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00529503

SG040-0005

Details and patient eligibility

About

This is a randomized trial to estimate the activity of R-ICE plus SGN-40 vs. R-ICE plus placebo in patients with DLBCL. The study will assess safety and tolerability and will measure any additional clinical benefit observed in patients receiving SGN-40.

Enrollment: 151 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of de novo or transformed DLBCL, or follicular grade 3b lymphoma.
• Received at least four cycles of first-line therapy with R-CHOP, or equivalent.
• Best clinical response to first-line therapy of stable disease, partial response, or complete response.
• At least one measureable lesion that is both greater than or equal to 1.5cm by radiographic imaging and by positive FDG-PET scan.

Exclusion criteria

• Leptomeningeal or central nervous system lymphoma.
• Received any therapy for relapsed or progressive disease except for local radiation, steroids, or rituximab.
• Received a hematopoietic stem cell transplant.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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151 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

SGN-40, rituximab, etoposide, carboplatin, ifosfamide

Treatment:

Drug: etoposide

Drug: rituximab

Drug: carboplatin

Drug: SGN-40

Drug: ifosfamide

2

Placebo Comparator group

Description:

placebo, rituximab, etoposide, carboplatin, ifosfamide

Treatment:

Drug: placebo

Drug: etoposide

Drug: rituximab

Drug: carboplatin

Drug: ifosfamide