Interventional Study on Pentostatin, Cyclophosphamide and Rituximab in Indolent B-Cell Non-Hodgkin-Lymphoma (B-NHL) (PERLL)
Primary Purpose
Immunocytoma/Morbus Waldenström, B-Cell Non-Hodgkin's Lymphoma, B-Cell Chronic Lymphocytic Leukemia
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cyclophosphamide, Pentostatin, Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Immunocytoma/Morbus Waldenström focused on measuring immunochemotherapy, Pentostatin, Cyclophosphamide, Rituximab, Maintenance, indolent B-NHL, B-CLL, B-NHL
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Immunochemotherapy, Maintencance
Arm Description
Outcomes
Primary Outcome Measures
Efficacy: overall response rate
Secondary Outcome Measures
Toxicity according to WHO-Grading
Efficacy: complete remission rate
Efficacy: partial remission rate
Efficacy: progression-free survival
Full Information
NCT ID
NCT00927797
First Posted
June 23, 2009
Last Updated
June 24, 2009
Sponsor
Heidelberg University
Collaborators
Diakonie Krankenhaus Schwäbisch Hall, Germany, Ludwig-Maximilians - University of Munich, Klinikum am Plattenwald, Bad Friedrichshall, Germany, Diakonie-Klinikum Stuttgart, Gemeinschaftspraxis Porowski & Koniczek, Heilbronn, Germany, Universitätsmedizin Mannheim
1. Study Identification
Unique Protocol Identification Number
NCT00927797
Brief Title
Interventional Study on Pentostatin, Cyclophosphamide and Rituximab in Indolent B-Cell Non-Hodgkin-Lymphoma (B-NHL)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2005 (undefined)
Primary Completion Date
January 2009 (Anticipated)
Study Completion Date
January 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Heidelberg University
Collaborators
Diakonie Krankenhaus Schwäbisch Hall, Germany, Ludwig-Maximilians - University of Munich, Klinikum am Plattenwald, Bad Friedrichshall, Germany, Diakonie-Klinikum Stuttgart, Gemeinschaftspraxis Porowski & Koniczek, Heilbronn, Germany, Universitätsmedizin Mannheim
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
185 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immunochemotherapy, Maintencance
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide, Pentostatin, Rituximab
Primary Outcome Measure Information:
Title
Efficacy: overall response rate
Time Frame
after 6 months and after 36 months
Secondary Outcome Measure Information:
Title
Toxicity according to WHO-Grading
Time Frame
throughout the treatment and until 36 months after
Title
Efficacy: complete remission rate
Time Frame
after 6 months and 36 months
Title
Efficacy: partial remission rate
Time Frame
after 6 months and 36 months
Title
Efficacy: progression-free survival
Time Frame
after 6 months and 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony D Ho, Ph.D., Prof.
Organizational Affiliation
Director of Department
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
http://www.klinikum.uni-heidelberg.de
Description
Homepage of the Department
Learn more about this trial
Interventional Study on Pentostatin, Cyclophosphamide and Rituximab in Indolent B-Cell Non-Hodgkin-Lymphoma (B-NHL)
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