FCM Versus R-FCM Followed by R-Maintenance or Observation Only
NCT ID: NCT00317096
Last Updated: 2021-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
319 participants
INTERVENTIONAL
1998-11-30
2021-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Induction Chemotherapy (R-CHOP Vs. R-FC) Followed by Interferon Maintenance Versus Rituximab Maintenance in MCL
NCT00209209
Significance of Duration of Maintenance Therapy With Rituximab in Non-Hodgkin Lymphomas
NCT00877214
Rituximab in Treating Patients With Follicular Non-Hodgkin's Lymphoma
NCT00227695
Comparison of High-Dose Chemotherapy + Rituximab and CHOP + Rituximab in High-Risk Follicular Lymphoma
NCT00435955
Rituximab Therapy in Follicular Lymphoma in Combination With Chemotherapy - REFLECT 1
NCT02461290
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
FCM
All patients underwent a central randomization procedure. Randomization was done by a Computer program stratified for histology, Response to the preceding chemotherapy, and the number of previous chemotherapies using the method of permutuated blocks.
The FCM combination comprised:
25 mg/m2 fludarabine per day iv over 30 minutes, days 1 to 3 200 mg/m2 cyclophosphamide per day as a 4-hour-infusion, days 1 to 3 8 mg/m2 mitoxantrone per day iv over 30 minutes, day 1 4 treatment Cycles á 4 weeks per cycle In patients with peripheral lymphocyte Counts more than 20.000/mm3 and/or a large Tumor mass (ie, bulky disease more than 10 cm) a cytoreductive pre-phase could be performed, comprising cyclophosphamide at a dose of 200 mg/m2 as a 1-hour-infusion over 3 to 5 days.
FCM
Active comparator: Chemotherapy
R-FCM
All patients underwent a central randomization procedure. Randomization was done by a Computer program stratified for histology, Response to the preceding chemotherapy, and the number of previous chemotherapies using the method of permutuated blocks.
The R-FCM combination comprised:
375 mg/m2 rituximab on the day before the respective FCM course. 25 mg/m2 fludarabine per day iv over 30 minutes, days 1 to 3 200 mg/m2 cyclophosphamide per day as a 4-hour-infusion, days 1 to 3 8 mg/m2 mitoxantrone per day iv over 30 minutes, day 1 4 treatment Cycles á 4 weeks per cycle In patients with peripheral lymphocyte Counts more than 20.000/mm3 and/or a large Tumor mass (ie, bulky disease more than 10 cm) a cytoreductive pre-phase could be performed, comprising cyclophosphamide at a dose of 200 mg/m2 as a 1-hour-infusion over 3 to 5 days.
R-FCM
experimental: Chemotherapy with additional rituximab
Observation only
Patients achieving a complete or partial remission after FCM or R-FCM underwent a subsequent randomization for 2 courses of rituximab to be given 3 and 6 months after completion of salvage therapy versus observation only.
This second randomization was stratified for the type of salvage therapy with FCM or R-FCM, the Response to this Treatment (CR or PR), and histology.
observation only
no Intervention after completion of FCM or R-FCM
rituximab maintenance
Patients achieving a complete or partial remission after FCM or R-FCM underwent a subsequent randomization for 2 courses of rituximab to be given 3 and 6 months after completion of salvage therapy versus observation only.
Courses of rituximab consisted of 4 doses of 375 mg/m2 per day given at 4 consecutive weeks.
This second randomization was stratified for the type of salvage therapy with FCM or R-FCM, the Response to this Treatment (CR or PR), and histology.
rituximab maintenance
2 courses of rituximab maintenance after completion of salvage therapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
FCM
Active comparator: Chemotherapy
R-FCM
experimental: Chemotherapy with additional rituximab
rituximab maintenance
2 courses of rituximab maintenance after completion of salvage therapy
observation only
no Intervention after completion of FCM or R-FCM
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ludwig-Maximilians - University of Munich
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof. Dr. Wolfgang Hiddemann
Prof. Dr. Wolfgang Hiddemann
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hiddemann Wolfgang, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Großhadern/LMU, Dept. of Medicine III
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
German Low Grade Study Group (Glsg)
Munich, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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. doi: 10.1182/blood-2004-04-1323. Epub 2004 Jul 29.
Forstpointner R, Unterhalt M, Dreyling M, Bock HP, Repp R, Wandt H, Pott C, Seymour JF, Metzner B, Hanel A, Lehmann T, Hartmann F, Einsele H, Hiddemann W; German Low Grade Lymphoma Study Group (GLSG). Maintenance therapy with rituximab leads to a significant prolongation of response duration after salvage therapy with a combination of rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) in patients with recurring and refractory follicular and mantle cell lymphomas: Results of a prospective randomized study of the German Low Grade Lymphoma Study Group (GLSG). Blood. 2006 Dec 15;108(13):4003-8. doi: 10.1182/blood-2006-04-016725. Epub 2006 Aug 31.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NHL-1998-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.