BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)
| Status: | Completed |
|---|---|
| Conditions: | Lymphoma, Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/10/2018 |
| Start Date: | July 2004 |
| End Date: | July 2010 |
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
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.
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.
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
We found this trial at
10
sites
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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