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

Sponsored by:	Cell Therapeutics
Information provided by:	Cell Therapeutics
ClinicalTrials.gov Identifier:	NCT00088530

Purpose

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.

Condition	Intervention	Phase
Lymphoma, Non-Hodgkin	Drug: pixantrone, cyclophosphamide, vincristine, rituximab, prednisone Drug: Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab	Phase III

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Cyclophosphamide Etoposide Prednisone Vincristine sulfate Vincristine Vinorelbine Vinorelbine tartrate Gemcitabine hydrochloride Gemcitabine Rituximab 6,9-Bis((2-aminoethyl)amino)benzo(g)isoquinoline-5,10-dione Etoposide phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Cell Therapeutics:

Primary Outcome Measures:

Response [ Time Frame: 84 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

toxicity [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	320
Study Start Date:	July 2004
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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)
2: Active Comparator	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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00088530

Show 100 Study Locations

Sponsors and Collaborators

Cell Therapeutics

More Information

CTI company website This link exits the ClinicalTrials.gov site

Responsible Party:	Cell Therapeutics ( Igor Gorbatchevsky, Medical Monitor )
Study ID Numbers:	PIX301
Study First Received:	July 28, 2004
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00088530
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cell Therapeutics:

Pixantrone
Non-Hodgkins lymphoma

Study placed in the following topic categories:

Prednisone
Immunoproliferative Disorders
Rituximab
Lymphoma, small cleaved-cell, diffuse
Vincristine
Cyclophosphamide
Etoposide phosphate
Lymphatic Diseases

Vinorelbine
Lymphoma, Non-Hodgkin
Aggression
Lymphoproliferative Disorders
Gemcitabine
Etoposide
Lymphoma

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antimitotic Agents
Hormones

Glucocorticoids
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009