Clinical Trial: Interventional Study on Pentostatin, Cyclophosphamide and Rituximab in Indolent B-Cell Non-Hodgkin-Lymphoma (B-NHL)

Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Phase II Study to Evaluate the Safety and Efficacy of the Treatment With Pentostatin, Cyclophosphamide and Rituximab Followed by Rituximab Maintenance in Previously Untreated and Relapsed Patients Wit

Brief Summary: The combination of Fludarabine and Cyclophosphamide have yielded overall response rates of over 80% in previously untreated patients with indolent Non-Hodgkin-Lymphoma. However, hematotoxicity rates were high with Grade 3 and 4 toxicities of over 50%. Several studies have indicated that the treatment with Pentostatin and Cyclophosphamide causes lower hematotoxicity rates than the combination of Fludarabine and Cyclophosphamide. To evaluate the efficacy and safety of treatment with Pentostatin/Cyclophosphamide immuno-chemotherapy for patients with newly diagnosed or relapsed Immunocytoma/Morbus Waldenström, B-cell chronic lymphocytic leukemia (B-CLL) and other indolent CD20-positive B-NHL, an open, non-randomized, multi-center prospective phase II-study to evaluate the efficacy and safety of treatment with immuno-chemotherapy is conducted. Treatment consists of 6 courses of Pentostatin (4mg/m² on day 1), Cyclophosphamide (600mg/m² on day 1) and Rituximab (375mg/m² on day 0) administered every three weeks. Patients achieving complete or partial remission undergo maintenance therapy consisting of 8 courses of Rituximab (375mg/m²) administered every three months over a period of 2 years.

Detailed Summary:
Sponsor: Heidelberg University

Current Primary Outcome: Efficacy: overall response rate [ Time Frame: after 6 months and after 36 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Toxicity according to WHO-Grading [ Time Frame: throughout the treatment and until 36 months after ]
  • Efficacy: complete remission rate [ Time Frame: after 6 months and 36 months ]
  • Efficacy: partial remission rate [ Time Frame: after 6 months and 36 months ]
  • Efficacy: progression-free survival [ Time Frame: after 6 months and 36 months ]


Original Secondary Outcome: Same as current

Information By: Heidelberg University

Dates:
Date Received: June 23, 2009
Date Started: February 2005
Date Completion: January 2012
Last Updated: June 24, 2009
Last Verified: June 2009