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

Last updated: May 6, 2021
Sponsor: Ludwig-Maximilians - University of Munich
Overall Status: Active - Not Recruiting

Phase

3

Condition

Lymphoma

Follicular Lymphoma

Treatment

N/A

Clinical Study ID

NCT00317096
NHL-1998-1
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 celltransplantation
  • two-dimensionally measurable lesion outside a previously irradiated area (osteoblasticbone 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

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 thestudy 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 valuesand/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 reliablecontraceptive method
  • severe psychiatric disease
  • serological positivity for HBV, HCV, HIV
  • previous organ transplantation other than autologous peripheral blood stem celltransplantation
  • missing written informed consent or missing written consent for data protection

Study Design

Total Participants: 319
Study Start date:
November 01, 1998
Estimated Completion Date:
June 30, 2021

Study 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.

Connect with a study center

  • German Low Grade Study Group (Glsg)

    Munich, D-81377
    Germany

    Site Not Available

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