Status:
COMPLETED
Primary Rituximab and Maintenance
Lead Sponsor:
Lymphoma Study Association
Collaborating Sponsors:
HOVON - Dutch Haemato-Oncology Association
German Low Grade Lymphoma Study Group
Conditions:
Follicular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
* Objectives * Primary objective: To evaluate in patients with advanced follicular lymphoma the benefit of maintenance therapy with rituximab after induction of response with chemotherapy plus ritu...
Detailed Description
Study medication * First period: Induction of response with 8 x rituximab combined with 8 cycles of CVP or 6 cycles of CHOP in 21-day cycles or 6 cycles of FCM in 28-day cycles or 6 cycles of MCP in ...
Eligibility Criteria
Inclusion
- Histologically confirmed follicular lymphoma grade 1, 2 or 3a.
- Patients previously untreated.
- Patients with at least one of the following symptoms requiring initiation of treatment:
- Bulky disease at study entry according to the GELF criteria: nodal or extranodal mass \> 7cm in its greater diameter
- B symptoms
- Elevated serum LDH or beta2-microglobulin
- involvement of at least 3 nodal sites (each with a diameter greater than 3 cm)
- symptomatic splenic enlargement
- compressive syndrome
- pleural/peritoneal effusion
- Age must be \> 18 years.
- Performance status \< 2 on the ECOG scale (see appendix E).
- Adequate hematological function within 28 days prior to registration (unless those abnormalities are related to lymphoma extension), this includes:
- Hemoglobin ≥ 8.0 g/dl (5.0 mmol/L)
- Absolute neutrophil count (ANC) ≥ 1.5 109/L
- Platelet count ≥ 100 109/L
- Women are not breast feeding, are using effective contraception, are not pregnant and agree not to become pregnant during participation in the trial and during the 12 months thereafter. Men agree not to father a child during participation in the trial and during the 12 months thereafter.
- Having previously signed a written informed consent form.
Exclusion
- Transformation to high-grade lymphoma (secondary to "low-grade" follicular lymphoma).
- Grade 3b follicular lymphoma.
- Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningitis).
- Patients regularly taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to \< 20 mg/day prednisone.
- Patients with prior or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer.
- Major surgery (excluding lymph node biopsy) within 28 days prior to registration.
- Poor renal function: Serum creatinine \> 2.0 mg/dl (197 μmol/L),
- Poor hepatic function: total bilirubin \> 2.0 mg/dl (34 μmol/L), AST (SGOT) \> 3 x the upper limit of normal unless these abnormalities are related to lymphoma.
- Known HIV infection or active HBV or HCV infection.
- Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease). Judgment is up to the investigator.
- Life expectancy \< 6 months
- Known sensitivity or allergy to murine products
- Treatment within a clinical trial within 30 days prior to trial entry
- Adult patient under tutelage.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
1217 Patients enrolled
Trial Details
Trial ID
NCT00140582
Start Date
December 1 2004
End Date
December 1 2016
Last Update
March 13 2017
Active Locations (24)
Enter a location and click search to find clinical trials sorted by distance.
1
Fundaleu Hospital
Buenos Aires, Argentina, CP C1114AAN
2
Australian Leukemia and Lymphoma Group
Melbourne, Australia
3
Université de Gent
Ghent, Belgium
4
Groupe d'Etude des Lymphomes de l'adulte
Mont-Godinne, Belgium