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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Immunocytoma/Morbus Waldenström, B-Cell Non-Hodgkin's Lymphoma, B-Cell Chronic Lymphocytic Leukemia

Intervention / Treatment
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* Drug: Cyclophosphamide, Pentostatin, Rituximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immunochemotherapy, Maintencance<br> | Drug: Cyclophosphamide, Pentostatin, Rituximab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: overall response rate |  | after 6 months and after 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunochemotherapy, Pentostatin, Cyclophosphamide, Rituximab, Maintenance, indolent B-NHL, B-CLL, B-NHL