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

B-Cell Chronic Lymphocytic Leukemia Clinical Trial

— PERLL  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00927797
• Other study ID #: L-278/2004
• Secondary ID: BfArM 4022892
• Status: Active, not recruiting
• Phase: Phase 2
• First received: June 23, 2009
• Last updated: June 24, 2009
• Start date: February 2005
• Est. completion date: January 2012

Study information

• Verified date: June 2009
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 185
• Est. completion date: January 2012
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Cyclophosphamide, Pentostatin, Rituximab

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Heidelberg University	Diakonie Krankenhaus Schwäbisch Hall, Germany, Diakonieklinikum Stuttgart, Germany, Gemeinschaftspraxis Porowski & Koniczek, Heilbronn, Germany, Klinikum am Plattenwald, Bad Friedrichshall, Germany, Ludwig-Maximilians - University of Munich, Universitätsmedizin Mannheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: overall response rate		after 6 months and after 36 months	Yes
Secondary	Toxicity according to WHO-Grading		throughout the treatment and until 36 months after	Yes
Secondary	Efficacy: complete remission rate		after 6 months and 36 months	Yes
Secondary	Efficacy: partial remission rate		after 6 months and 36 months	Yes
Secondary	Efficacy: progression-free survival		after 6 months and 36 months	Yes

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