FCM Versus R-FCM Followed by R-Maintenance or Observation Only
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Remission rate
- Event free interval
- Time to Progression
- Overall survival
- adverse events
- serious infectious complications
| Estimated Enrollment: | 300 |
| Study Start Date: | November 1998 |
| Estimated Study Completion Date: | December 2008 |
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 |
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| Germany | |
| German Low Grade Study Group (Glsg) | |
| Munich, Germany, D-81377 | |
| 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 May 16, 2013