Interventional Study on Pentostatin, Cyclophosphamide and Rituximab in Indolent B-Cell Non-Hodgkin-Lymphoma (B-NHL) (PERLL)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by University of Heidelberg.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Heidelberg
Collaborators:
Diakonie Krankenhaus Schwäbisch Hall, Germany
University Munich "Großhadern", Medical Clinic III, Germany
Klinikum am Plattenwald, Bad Friedrichshall, Germany
Diakonieklinikum Stuttgart, Germany
Gemeinschaftspraxis Porowski & Koniczek, Heilbronn, Germany
University Hospital Mannheim
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00927797
First received: June 23, 2009
Last updated: June 24, 2009
Last verified: June 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Immunocytoma/Morbus Waldenström B-Cell Non-Hodgkin's Lymphoma B-Cell Chronic Lymphocytic Leukemia |
Drug: Cyclophosphamide, Pentostatin, Rituximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by University of Heidelberg:
Primary Outcome Measures:
- Efficacy: overall response rate [ Time Frame: after 6 months and after 36 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Toxicity according to WHO-Grading [ Time Frame: throughout the treatment and until 36 months after ] [ Designated as safety issue: Yes ]
- Efficacy: complete remission rate [ Time Frame: after 6 months and 36 months ] [ Designated as safety issue: Yes ]
- Efficacy: partial remission rate [ Time Frame: after 6 months and 36 months ] [ Designated as safety issue: Yes ]
- Efficacy: progression-free survival [ Time Frame: after 6 months and 36 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 185 |
| Study Start Date: | February 2005 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Immunochemotherapy, Maintencance | Drug: Cyclophosphamide, Pentostatin, Rituximab |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00927797
Sponsors and Collaborators
University of Heidelberg
Diakonie Krankenhaus Schwäbisch Hall, Germany
University Munich "Großhadern", Medical Clinic III, Germany
Klinikum am Plattenwald, Bad Friedrichshall, Germany
Diakonieklinikum Stuttgart, Germany
Gemeinschaftspraxis Porowski & Koniczek, Heilbronn, Germany
University Hospital Mannheim
Investigators
| Principal Investigator: | Anthony D Ho, Ph.D., Prof. | Director of Department |
More Information
Additional Information:
No publications provided
| Responsible Party: | Prof. Dr. med. A. D. Ho, University of Heidelberg |
| ClinicalTrials.gov Identifier: | NCT00927797 History of Changes |
| Other Study ID Numbers: | L-278/2004, BfArM 4022892 |
| Study First Received: | June 23, 2009 |
| Last Updated: | June 24, 2009 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University of Heidelberg:
|
immunochemotherapy Pentostatin Cyclophosphamide Rituximab |
Maintenance indolent B-NHL B-CLL B-NHL |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Rituximab |
Pentostatin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Adenosine Deaminase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013