BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)

Phase 3

Completed

Interventions: Drug: pixantrone, cyclophosphamide, vincristine, rituximab, prednisone
Drug: Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab

Brief Summary: BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and shows reduced potential for cardiotoxicity in animal models. This cytotoxic agent has structural similarities with mitoxantrone as well as general similarities with anthracyclines (such as the tricyclic central quinoid chromophore).

Detailed Description: The primary study objective is to compare the efficacy of BBR 2778 to a selection of single agents. Secondary objectives are to compare the safety and tolerability of BBR 2778 to a selection of single agents, and to assess the pharmacokinetic parameters of BBR 2778 in a subset of this patient population.

Recruitment & Eligibility

Inclusion Criteria

Histologically confirmed aggressive [de novo or transformed] NHL according to REAL/WHO classification.
At least one objectively measurable lesion as demonstrated by CT, spiral CT, or MRI and plain radiograph of the chest (chest x-ray, for chest lesions only) that can be followed for response as target lesion.
Relapse after 2 or more prior regimens of chemotherapy
ECOG performance status of 0, 1, or 2
Adequate hematologic, renal and hepatic function
LVEF ≥50% determined by MUGA scan

Exclusion Criteria

Prior treatment with a cumulative dose of doxorubicin or equivalent exceeding 450 mg/m²
Prior allogenic stem cell transplant
Histological diagnosis of Burkitt lymphoma, lymphoblastic lymphoma or Mantle cell lymphoma
Active CNS lymphoma or HIV-related lymphoma.
Any chemotherapy, radiotherapy, or other anticancer treatment (including corticosteroid, 10 or more mg/day of prednisone or equivalent) within the 2 weeks before randomization
Pregnant women or nursing mothers

Arm && Interventions

Group	Intervention	Description
Experimental Arm	pixantrone, cyclophosphamide, vincristine, rituximab, prednisone	Pixantrone (BBR2778)
Comparator Arm	Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab	To be chosen by the investigator, among vinorelbine, oxaliplatin, ifosfamide, etoposide or mitoxantrone

Primary Outcome Measures

Name	Time	Method
Complete Response (CR) and Complete Response Unconfirmed (CRu)	EOT; approximately 6 months	Proportion of patients with a best response of complete response (CR) or Complete Response unconfirmed (CRu) in the End Of Treatment (EOT) or End Of Study (EOS) analyses by independent assessment in the Intent-to-treat (ITT) population through the End of Treatment (EOT)

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	18 months after 6 cycles of treatment; approximately 24 months	The time between the date of randomization and the date of the initial documentation of progressive/relapsed disease or death due to any cause.
Overall Survival	18 months after 6 cycles of treatment; approximately 24 months	The time between the date of randomization and the date of death due to any cause.
Overall Response Rate (ORR) Lasting at Least 4 Months	approximately 24 months	The proportion of patients with Complete response or Partial Response with a difference from the first documented objective response to disease progression or death of at least 4 months.

Locations (99): Robert A. Moss, M.D., FACP, Inc.
🇺🇸
Fountain Valley, California, United States
UCLA Medical Center
🇺🇸
Los Angeles, California, United States
Watson Clinic for Cancer Care and Research
🇺🇸
Lakeland, Florida, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
New Mexico Oncology/Hematology
🇺🇸
Albuquerque, New Mexico, United States
SUNY Upstate Medical University
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Syracuse, New York, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Northwest Kaiser Permanente
🇺🇸
Portland, Oregon, United States
Northern Utah Hematology Oncology, P.C.
🇺🇸
Ogden, Utah, United States
Clinica Modelo S.A.
🇦🇷
Parana, Entre Rios, Argentina
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Robert A. Moss, M.D., FACP, Inc.
🇺🇸Fountain Valley, California, United States