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

Heidelberg University

Status and phase: Unknown; Phase 2

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

Treatments: Drug: Cyclophosphamide, Pentostatin, Rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT00927797

BfArM 4022892

L-278/2004

Details and patient eligibility

About

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.

Enrollment: 185 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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185 participants in 1 patient group

Immunochemotherapy, Maintencance

Experimental group

Treatment:

Drug: Cyclophosphamide, Pentostatin, Rituximab