FCM Versus R-FCM Followed by R-Maintenance or Observation Only

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2005 by German Low Grade Lymphoma Study Group.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
German Low Grade Lymphoma Study Group
ClinicalTrials.gov Identifier:
NCT00317096
First received: April 20, 2006
Last updated: April 21, 2006
Last verified: April 2005
  Purpose

The aim of this phase III trial is to assess the safety and efficacy of treatment with rituximab in combination with FCM chemotherapy (R-FCM) versus FCM chemotherapy alone for remission induction and to asses the safety and efficacy of rituximab maintenance versus observation only after response to induction therapy. Both questions are addressed in way of a prospective randomized comparison in patients with relapsed FL, MCL and LP lymphoma.


Condition Intervention Phase
Lymphoma, Follicular
Lymphoma, Low-Grade
Lymphoma, Intermediate-Grade
Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Mitoxantrone
Drug: Rituximab
Procedure: chemotherapy: FCM
Procedure: chemotherapy: R-FCM
Procedure: maintenance therapy: Rituximab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Relapsed CBCC, CC and LPIC Lymphoma With FCM Chemotherapy Alone or in Combination With the Monoclonal Anti CD 20 Antibody Rituximab Followed by Anti-CD 20 Maintenance or Observation Only

Resource links provided by NLM:


Further study details as provided by German Low Grade Lymphoma Study Group:

Primary Outcome Measures:
  • Remission rate
  • Event free interval

Secondary Outcome Measures:
  • Time to Progression
  • Overall survival
  • adverse events
  • serious infectious complications

Estimated Enrollment: 300
Study Start Date: November 1998
Estimated Study Completion Date: December 2008
Detailed Description:

Patients with relapsed centroblastic/centrocytic (FL), centrocytic (MCL)or lymphoplasmacytoid lymphoma are randomly assigned to either FCM chemotherapy alone or to FCM chemotherapy in combination with the monoclonal anti-CD20 antibody rituximab (R-FCM). FCM chemotherapy will be given for 4 cycles in intervals of 4 weeks.

In patients assigned to cytoreductive therapy with FCM plus rituximab, the monoclonal antibody is given as one infusion (375 mg/m2) on the day before the respective FCM course for a total of four applications.

Four weeks after the end of FCM chemotherapy patients with CR or PR are randomly assigned to either no further treatment or maintenance therapy with rituximab. Rituximab will be given 4 times (one infusion per week with 375 mg/m2). After six months rituximab treatment will be repeated with another 4 infusions.

In case of relapse patients will receive an alternative treatment according to the decision of the investigator.

The aim of this phase III trial is to assess the safety and efficacy of treatment with rituximab in combination with FCM chemotherapy versus FCM chemotherapy alone for remission induction and to asses the safety and efficacy of rituximab maintenance versus observation only after response to induction therapy. Both questions are addressed in way of a prospective randomized comparison in patients with relapsed FCL, MCL and LP lymphoma.

Primary objectives of this trial are to compare (1) the remission rates (CR and PR) achieved after FCM plus rituximab versus FCM alone and (2) the progression free interval of rituximab maintenance versus observation only.

  Eligibility

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

Inclusion Criteria

  • patients with histologically proven stage III/IV centroblastic/centrocytic (FL), centrocytic (MCL)or lymphoplasmacytoid lymphoma (LPIC).
  • relapsed disease after initial chemotherapy or peripheral blood stem cell transplantation
  • two-dimensionally measurable lesion outside a previously irradiated area (osteoblastic bone lesions, ascites, and pleural effusions are not evaluable)
  • age > 18 years
  • Karnofsky-index > 60
  • life expectancy of at least 3 months
  • effective contraception in female premenopausal patients
  • patient's written informed consent

Exclusion Criteria:

  • age < 18 years
  • Karnofsky-index < 60
  • treatment with fludarabine or mitoxantrone within the preceding three months
  • active auto-immune hemolytic anemia at the start of FCM chemotherapy
  • participation in another clinical trial during the last 4 weeks
  • participation in this study before
  • previous treatment with murine antibodies
  • concurrent diseases which exclude the administration of therapy as outlined by the study protocol
  • non-compensated heart failure
  • dilatative cardiomyopathy
  • coronary heart disease with ST segment depression in ECG
  • myocardial infarction during the last 6 months
  • chronic lung disease with hypoxemia
  • severe non-compensated hypertension
  • severe non-compensated diabetes mellitus
  • renal insufficiency (creatinine > 2.0 mg/dl), not related to lymphoma
  • hepatic insufficiency with transaminase values greater than 3-fold of normal values and/or bilirubin levels > 2.0 mg/dl, not related to lymphoma
  • clinical signs of cerebral dysfunction
  • women during lactation or pregnancy or of childbearing potential not using a reliable contraceptive method
  • severe psychiatric disease
  • serological positivity for HBV, HCV, HIV
  • previous organ transplantation other than autologous peripheral blood stem cell transplantation
  • missing written informed consent or missing written consent for data protection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00317096

Locations
Germany
German Low Grade Study Group (Glsg)
Munich, Germany, D-81377
Sponsors and Collaborators
German Low Grade Lymphoma Study Group
Investigators
Principal Investigator: Hiddemann Wolfgang, PhD University Hospital Großhadern/LMU, Dept. of Medicine III
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00317096     History of Changes
Other Study ID Numbers: NHL-1998-1
Study First Received: April 20, 2006
Last Updated: April 21, 2006
Health Authority: Germany: Ethics Commission

Keywords provided by German Low Grade Lymphoma Study Group:
Drug Therapy
Maintenance
rituximab

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Fludarabine monophosphate
Rituximab
Fludarabine
Mitoxantrone
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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Antimetabolites, Antineoplastic

ClinicalTrials.gov processed this record on April 16, 2014