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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. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Heidelberg University.
Recruitment status was:  Active, not recruiting
Sponsor:
Collaborators:
Diakonie Krankenhaus Schwäbisch Hall, Germany
Ludwig-Maximilians - University of Munich
Klinikum am Plattenwald, Bad Friedrichshall, Germany
Diakonieklinikum Stuttgart, Germany
Gemeinschaftspraxis Porowski & Koniczek, Heilbronn, Germany
Universitätsmedizin Mannheim
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00927797
First received: June 23, 2009
Last updated: June 24, 2009
Last verified: June 2009
  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
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 Heidelberg University:

Primary Outcome Measures:
  • Efficacy: overall response rate [ Time Frame: after 6 months and after 36 months ]

Secondary Outcome Measures:
  • 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 ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927797

Sponsors and Collaborators
Heidelberg University
Diakonie Krankenhaus Schwäbisch Hall, Germany
Ludwig-Maximilians - University of Munich
Klinikum am Plattenwald, Bad Friedrichshall, Germany
Diakonieklinikum Stuttgart, Germany
Gemeinschaftspraxis Porowski & Koniczek, Heilbronn, Germany
Universitätsmedizin Mannheim
Investigators
Principal Investigator: Anthony D Ho, Ph.D., Prof. Director of Department
  More Information

Additional Information:
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

Keywords provided by Heidelberg University:
immunochemotherapy
Pentostatin
Cyclophosphamide
Rituximab
Maintenance
indolent B-NHL
B-CLL
B-NHL

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia
Leukemia, B-Cell
Cyclophosphamide
Rituximab
Pentostatin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
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 June 26, 2017