Clinical trial NCT00927797: Interventional Study on Pentostatin, Cyclophosphamide and Rituximab in Indolent B-Cell Non-Hodgkin-Lymphoma (B-NHL)
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 With Immunocytoma/Morbus Waldenström, B-CLL and Other Indolent B-Cell Lymphomas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Immunocytoma/Morbus Waldenström
B-Cell Non-Hodgkin's Lymphoma
B-Cell Chronic Lymphocytic Leukemia
Keywords: immunochemotherapy
Pentostatin
Cyclophosphamide
Rituximab
Maintenance
indolent B-NHL
B-CLL
B-NHL
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Diakonie Krankenhaus Schwäbisch Hall, Germany
name: Ludwig-Maximilians - University of Munich
name: Klinikum am Plattenwald, Bad Friedrichshall, Germany
name: Diakonie-Klinikum Stuttgart
name: Gemeinschaftspraxis Porowski & Koniczek, Heilbronn, Germany
name: Universitätsmedizin Mannheim
First posted: 2009-06-25
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy: overall response rate
timeFrame: after 6 months and after 36 months
Secondary outcomes:
measure: Toxicity according to WHO-Grading
timeFrame: throughout the treatment and until 36 months after
measure: Efficacy: complete remission rate
timeFrame: after 6 months and 36 months
measure: Efficacy: partial remission rate
timeFrame: after 6 months and 36 months
measure: Efficacy: progression-free survival
timeFrame: after 6 months and 36 months
Other outcomes:
Locations:
Study officials:
affiliation: Director of Department
name: Anthony D Ho, Ph.D., Prof.
role: PRINCIPAL_INVESTIGATOR
References: