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

Phase 2

• Conditions: Immunocytoma/Morbus Waldenström; B-Cell Non-Hodgkin's Lymphoma; B-Cell Chronic Lymphocytic Leukemia
• Interventions: Drug: Cyclophosphamide, Pentostatin, Rituximab

• Registration Number: NCT00927797
• Lead Sponsor: Heidelberg University

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 Description

Not available

Study Timeline

• Study Start: 2005-02
• Primary Completion: 2009-01
• Status Verified: 2009-06
• Study First Submitted: 2009-06-23
• Study First Submitted QC: 2009-06-24
• Last Update Submitted: 2009-06-24
• Study First Posted: 2009-06-25
• Last Update Posted: 2009-06-25
• Study Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 185

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Immunochemotherapy, Maintencance	Cyclophosphamide, Pentostatin, Rituximab	-

Primary Outcome Measures

Name	Time	Method
Efficacy: overall response rate	after 6 months and after 36 months

Secondary Outcome Measures

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