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

Overview

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.

Full Title of Study: “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 With Immunocytoma/Morbus Waldenström, B-CLL and Other Indolent B-Cell Lymphomas”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2009

Interventions

  • Drug: Cyclophosphamide, Pentostatin, Rituximab

Arms, Groups and Cohorts

  • Experimental: Immunochemotherapy, Maintencance

Clinical Trial Outcome Measures

Primary Measures

  • Efficacy: overall response rate
    • Time Frame: after 6 months and after 36 months

Secondary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • confirmed first diagnosis of or relapsed CD20-positive Immunocytoma, B-CLL or other indolent B-NHL – therapy-requiring CLL defined as: Binet stage C or Binet B combined with occurence of B-symptoms, rapidly progressing disease, risk of organ compression by lymphoma mass – therapy-requiring Immunocytoma as defined by the Consensus Panel Recommendations from the Second International Workshop on Waldenström´s Macroglobulinemia, 2003) – age > 18 years – anticipated life expectancy > 6 months – ECOG 0-3 – no significant comorbidities – signed informed consent – efficient method of contraception during time of therapy (men and women) Exclusion Criteria:

  • age < 18 years – CD20 negativity – significant comorbidities interfering with therapy as required by the protocol – history of HIV infection or active hepatitis

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Heidelberg University
  • Collaborator
    • Diakonie Krankenhaus Schwäbisch Hall, Germany
  • Provider of Information About this Clinical Study
    • Prof. Dr. med. A. D. Ho, University of Heidelberg
  • Overall Official(s)
    • Anthony D Ho, Ph.D., Prof., Principal Investigator, Director of Department

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