Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, Follicular, Lymphoma, Low-Grade, Lymphoma, Intermediate-Grade

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Remission rate

Principal Investigator

Hiddemann Wolfgang, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital GroƟhadern/LMU, Dept. of Medicine III

Authority:

Germany: Ethics Commission

Study ID:

NHL-1998-1

NCT ID:

NCT00317096

Start Date:

November 1998

Completion Date:

December 2008

Related Keywords:

  • Lymphoma, Follicular
  • Lymphoma, Low-Grade
  • Lymphoma, Intermediate-Grade
  • Drug Therapy
  • Maintenance
  • rituximab
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin

Name

Location