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 Heidelberg University.
Recruitment status was  Active, not recruiting
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 Identifier:
First received: June 23, 2009
Last updated: June 24, 2009
Last verified: June 2009
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 Heidelberg University:

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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its 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
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 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 Heidelberg University:
indolent B-NHL

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Adenosine Deaminase Inhibitors
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Physiological Effects of Drugs processed this record on May 26, 2016