This trial is active, not recruiting.

Conditions immunocytoma/morbus waldenström, b-cell non-hodgkin's lymphoma, b-cell chronic lymphocytic leukemia
Treatment cyclophosphamide, pentostatin, rituximab
Phase phase 2
Sponsor Heidelberg University
Collaborator Diakonie Krankenhaus Schwäbisch Hall, Germany
Start date February 2005
End date January 2009
Trial size 185 participants
Trial identifier NCT00927797, BfArM 4022892, L-278/2004


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
cyclophosphamide, pentostatin, rituximab

Primary Outcomes

Efficacy: overall response rate
time frame: after 6 months and after 36 months

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Anthony D Ho, Ph.D., Prof.
Trial information was received from ClinicalTrials.gov and was last updated in June 2009.
Information provided to ClinicalTrials.gov by Heidelberg University.