Phase II Study of Ofatumumab Plus Ifosfamide, Carboplatin, Etoposide (ICE) or Dexamethasone, Cytarabine, Cisplatin (DHAP) Chemotherapy Regimen in Relapsed/ Refractory Diffuse Large B Cell Lymphoma (DLBCL)

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of ofatumumab used in combination with ifosfamide, carboplatin, etoposide (ICE) or dexamethasone, cytarabine, cisplatin (DHAP) salvage chemotherapy regimens in subjects with relapsed or refractory diffuse large B cell lymphoma (DLBCL) who are eligible for autologous stem cell transplant.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Antibodies, Monoclonal; Carboplatin; Cytarabine; Dexamethasone; Etoposide; Ifosfamide; Ofatumumab

Criteria

Inclusion Criteria:

• Subjects with CD20 positive aggressive non-Hodgkin's lymphoma (NHL) including DLBCL, transformed follicular lymphoma (FL) & grade 3b FL.

Refractory to, or relapsed following, first-line treatment with rituximab combined with anthracycline- or anthracenedione-based chemotherapy as defined by the protocol.

• Computed tomography (CT) with involvement of 2 or more clearly demarcated lesions with a long axis > 1.5 centimeters (cm) and short axis ≥ 1.0 cm or 1 clearly demarcated lesion with a long axis >2.0 cm and short axis ≥1.0 cm.

• Baseline [18F] fluorodeoxyglucose (FDG)-positron emission tomography (PET) scans must demonstrate positive lesions compatible with CT defined anatomical tumor sites.

• Age 18 yrs or older.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

• Eligible for high dose chemotherapy and autologous stem cell transplant (ASCT).

• Resolution of toxicities from first-line therapy to a grade that in the opinion of the investigator does not contraindicate study participation.

• Signed written informed consent.

Exclusion Criteria:

• Previous cancer therapy for lymphoma, with the exception of required rituximab/ anthracycline- or anthracenedione-based chemotherapy, monotherapy rituximab prior to first-line therapy and / or as a maintenance therapy, or limited field radiotherapy (as defined by the protocol).

• Any anti-cancer therapy, except limited field radiotherapy, within 2 weeks prior to start of study therapy.

• Chronic Glucocorticoid use (limited acute use is allowed and defined by the protocol).

• History of significant cerebrovascular disease.

• Abnormal/ inadequate white blood cell (WBC) count, liver, and kidney function.

• Clinically significant cardiac disease, active or chronic infections, serious significant diseases, other cancer within last 5 years.

• Known or suspected hypersensitivity to study treatments.

• Prior treatment with anti-CD20 monoclonal antibodies, at any time, or treated with other monoclonal antibodies within 3 months prior to start of study therapy, with the exception of rituximab in both instances.

• Inability to comply with the protocol activities.

• Pregnant or lactating women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception during and up to 1 year following dosing completion.