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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
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

    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
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    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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