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

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ClinicalTrials.gov Identifier: NCT00088530
Recruitment Status : Completed
First Posted : July 29, 2004
Results First Posted : June 1, 2017
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
CTI BioPharma

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).

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 or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Drug: pixantrone, cyclophosphamide, vincristine, rituximab, prednisone Drug: Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2004
Actual Primary Completion Date : February 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. Complete Response (CR) and Complete Response Unconfirmed (CRu) [ Time Frame: 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 :
  1. Progression-Free Survival (PFS) [ Time Frame: 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.

  2. Overall Survival [ Time Frame: 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.

  3. Overall Response Rate (ORR) Lasting at Least 4 Months [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00088530


  Show 99 Study Locations
Sponsors and Collaborators
CTI BioPharma

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CTI BioPharma
ClinicalTrials.gov Identifier: NCT00088530     History of Changes
Obsolete Identifiers: NCT00101049
Other Study ID Numbers: PIX301
First Posted: July 29, 2004    Key Record Dates
Results First Posted: June 1, 2017
Last Update Posted: November 8, 2018
Last Verified: November 2018

Keywords provided by CTI BioPharma:
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
Gemcitabine
Etoposide
Pixantrone
Cyclophosphamide
Vinorelbine
Rituximab
Prednisone
Vincristine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists