BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)
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| ClinicalTrials.gov Identifier: NCT00088530 |
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Recruitment Status :
Completed
First Posted : July 29, 2004
Results First Posted : June 1, 2017
Last Update Posted : February 5, 2020
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Sponsor:
CTI BioPharma
Information provided by (Responsible Party):
CTI BioPharma
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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).
| 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 |
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.
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Experimental Arm
Pixantrone (BBR2778)
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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 |
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Active Comparator: Comparator Arm
To be chosen by the investigator, among vinorelbine, oxaliplatin, ifosfamide, etoposide or mitoxantrone
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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 :
- 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 :
- 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.
- 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.
- 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
Locations
Show 99 study locations
Sponsors and Collaborators
CTI BioPharma
Investigators
| Study Director: | Simran Singh | Sr. Director, Clinical Operations |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | CTI BioPharma |
| ClinicalTrials.gov Identifier: | NCT00088530 |
| 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: | February 5, 2020 |
| Last Verified: | January 2020 |
Keywords provided by CTI BioPharma:
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Pixantrone Non-Hodgkins lymphoma |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, Non-Hodgkin Pixantrone Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Gemcitabine Prednisone Cyclophosphamide Rituximab Etoposide Vincristine |
Vinorelbine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Immunological Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents |