Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Behaviors and Mental Disorders

Rare Diseases

Lymphoma

Lymphoma, Non-Hodgkin

Aggression

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Antineoplastic Agents

All Drugs and Chemicals

Analgesics

Antirheumatic Agents

Anti-Inflammatory Agents

Etoposide

Gemcitabine

Vinorelbine

Mitoxantrone

Cyclophosphamide

Prednisone

Rituximab

Vincristine

Oxaliplatin

Ifosfamide

Etoposide phosphate

Isophosphamide mustard

Pixantrone

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Antimetabolites

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Tubulin Modulators

Antimitotic Agents

To be chosen by the investigator, among vinorelbine, oxaliplatin, ifosfamide, etoposide or mitoxantrone

Day 1: pixantrone (150 mg/m2), cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day)

pixantrone, cyclophosphamide, vincristine, rituximab, prednisone

Day 1: cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day)

Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab

Simran Singh

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).

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.

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

Pixantrone (BBR 2778) Versus Other Chemotherapeutic Agents for Third-line Single Agent Treatment of Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma: A Randomized, Controlled, Phase III Comparative Trial

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)

The time between the date of randomization and the date of the initial documentation of progressive/relapsed disease or death due to any cause.

The time between the date of randomization and the date of death due to any cause.

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.

CTI BioPharma

An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.

Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle

Experimental Group

Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab

Comparator Group

Total

Age at Randomization (years)

Age, Continuous

18 to < 30

30 to < 40

40 to < 50

50 to < 60

60 to < 70

70 to < 80

≥ 80

Age, Customized

Sex: Female, Male

Caucasian

Black

Asian

Hispanic

Native American

Other

Race/Ethnicity, Customized

North America

Argentina

Bulgaria

Colombia

Ecuador

Hungary

India

Peru

Poland

Romania

Russian Federation

Ukraine

Uruguay

France

United Kingdom

Germany

Italy

Demographic data will be displayed and summary statistics will be used to describe the study population (i.e., means, medians, and ranges of age, weight, and height, and frequencies for race, gender, baseline performance status, and tumor types and histology). No formal statistical tests will be done.

Region of Enrollment

Eastern Cooperative Oncology Group (ECOG) Performance Status Grade as published in Oken MM, et al. ECOG PS grade 0- Fully active, able to carry on all predisease performance without restriction; 1 - restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg, light house work, office work; 2- ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3- capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)	NCT00088530	Lymphoma, Non-H...	pixantrone, cyc... Vinorelbine, Ox...	18 Years -	CTI BioPharma
BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)	NCT00088530	Lymphoma, Non-H...	pixantrone, cyc... Vinorelbine, Ox...	18 Years -	CTI BioPharma

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