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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cell Therapeutics
ClinicalTrials.gov Identifier:
NCT00088530
First received: July 28, 2004
Last updated: May 20, 2013
Last verified: May 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]

Enrollment: 140
Study Start Date: July 2004
Study Completion Date: July 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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)
Other Name: BBR2778
Active Comparator: 2 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 99 Study Locations
Sponsors and Collaborators
Cell Therapeutics
  More Information

Additional Information:
No publications provided by Cell Therapeutics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cell Therapeutics
ClinicalTrials.gov Identifier: NCT00088530     History of Changes
Obsolete Identifiers: NCT00101049
Other Study ID Numbers: PIX301
Study First Received: July 28, 2004
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Cell Therapeutics:
Pixantrone
Non-Hodgkins lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Gemcitabine
Rituximab
Vinorelbine
Pixantrone
Etoposide
Prednisone
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on April 23, 2014