MedTrace Logo

Interventional Study on Pentostatin, Cyclophosphamide and Rituximab in Indolent B-Cell Non-Hodgkin-Lymphoma (B-NHL)

NCT00927797 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2009-06-25

No results posted yet for this study

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.

Conditions

  • Immunocytoma/Morbus Waldenström
  • B-Cell Non-Hodgkin's Lymphoma
  • B-Cell Chronic Lymphocytic Leukemia

Interventions

DRUG

Cyclophosphamide, Pentostatin, Rituximab

Sponsors & Collaborators

  • Diakonie Krankenhaus Schwäbisch Hall, Germany

    collaborator UNKNOWN

  • Ludwig-Maximilians - University of Munich

    collaborator OTHER

  • Klinikum am Plattenwald, Bad Friedrichshall, Germany

    collaborator UNKNOWN

  • Diakonie-Klinikum Stuttgart

    collaborator OTHER

  • Gemeinschaftspraxis Porowski & Koniczek, Heilbronn, Germany

    collaborator UNKNOWN

  • Universitätsmedizin Mannheim

    collaborator OTHER

  • Heidelberg University

    lead OTHER

Principal Investigators

  • Anthony D Ho, Ph.D., Prof. · Director of Department

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2009-01-31
Completion
2012-01-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00927797 on ClinicalTrials.gov