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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Lymphoma, Non-Hodgkin

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response

Outcome Time Frame:

84 days

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

PIX301

NCT ID:

NCT00088530

Start Date:

July 2004

Completion Date:

July 2010

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • Pixantrone
  • Non-Hodgkins lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Rush University Medical CenterChicago, Illinois  60612-3824
Duke University Medical CenterDurham, North Carolina  27710
SUNY Upstate Medical UniversitySyracuse, New York  13210
UCLA Medical CenterLos Angeles, California  90095-7059
New Mexico Oncology/HematologyAlbuquerque, New Mexico  87109
Robert A. Moss, M.D., FACP, Inc.Fountain Valley, California  92708
Watson Clinic for Cancer Care and ResearchLakeland, Florida  33805
Northwest Kaiser PermanentePortland, Oregon  97227
Northern Utah Hematology Oncology, P.C.Ogden, Utah  84403