FCM Versus R-FCM Followed by R-Maintenance or Observation Only - Full Text View

Sponsored by:	German Low Grade Lymphoma Study Group
Information provided by:	German Low Grade Lymphoma Study Group
ClinicalTrials.gov Identifier:	NCT00317096

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 III

MedlinePlus related topics: Lymphoma

Drug Information available for: Cyclophosphamide Mitoxantrone hydrochloride Mitoxantrone Fludarabine Fludarabine monophosphate Rituximab Tositumomab Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
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

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 of Results:

Forstpointner R, Dreyling M, Repp R, Hermann S, Hanel A, Metzner B, Pott C, Hartmann F, Rothmann F, Rohrberg R, Bock HP, Wandt H, Unterhalt M, Hiddemann W; German Low-Grade Lymphoma Study Group. The addition of rituximab to a combination of fludarabine, cyclophosphamide, mitoxantrone (FCM) significantly increases the response rate and prolongs survival as compared with FCM alone in patients with relapsed and refractory follicular and mantle cell lymphomas: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood. 2004 Nov 15;104(10):3064-71. Epub 2004 Jul 29.

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

Keywords provided by German Low Grade Lymphoma Study Group:

Drug Therapy
Maintenance
rituximab

Study placed in the following topic categories:

Immunoproliferative Disorders
Rituximab
Lymphoma, Follicular
Cyclophosphamide
Fludarabine monophosphate
Lymphatic Diseases
Antibodies

Fludarabine
Mitoxantrone
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Follicular lymphoma
Immunoglobulins

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms

Sensory System Agents
Therapeutic Uses
Myeloablative Agonists
Peripheral Nervous System Agents
Analgesics
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Central Nervous System Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009