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

CompletadoFase 3ClinicalTrials.gov

ID: NCT00088530Tipo: INTERVENTIONALInicio: 1 de jul de 2004Fin estimado: 1 de jul de 2010

Traducción no disponible, mostrando original

Resumen

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).

Descripción detallada

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

pixantrone, cyclophosphamide, vincristine, rituximab, prednisone

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)

drug

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

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

Ubicaciones

Clinica Modelo S.A.

Paraná, Entre Ríos Province, Argentina

Instituto de Investigaciones Clinicas

Rosario, Santa Fe Province, Argentina

Centro Oncologico Rosario

Rosario, Santa Fe Province, Argentina

FUNDALEU - fundacion para combatir le Leucernia

Buenos Aires, Argentina

Hospital Universitario Austral

Buenos Aires, Argentina

Academia Nacional de Medicina

Caba, Argentina

Hospital Privado Centro Medico de Cordoba S.A.

Córdoba, Argentina

ISIS Clinica Especializada

Santa Fe, Argentina

Patrocinadores

PrincipalCTI BioPharma

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