A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment versus Observation alone in Patients with Aggressive B-cell lymphoma:NHL-13 - NHL-13 (ML18223)
- Conditions
- Aggressive Non Hodgkin´s Lymphoma (NHL)
- Registration Number
- EUCTR2005-005187-90-SI
- Lead Sponsor
- AGMT: Arbeitsgemeinschaft Medikamentöse Tumortherapie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
Patients must have received eight infusions of rituximab plus 4 – 8 cycles of CHOP-like chemotherapy including an anthracycline
Induction treatment must have been completed with the application of the final cycle of chemotherapy or immunotherapy no longer than 12 weeks, and no earlier than 4 weeks before trial treatment start.
Patients must have reached a complete remission (CR) or an unconfirmed CR (CRu) after induction therapy
Histologic diagnosis of either diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma grade 3b according to the WHO/REAL classification at time of diagnosis (prior to induction therapy)
Confirmed CD20 positivity of the lymphoma at time of diagnosis (prior to induction therapy)
ECOG performance status of 0, 1 or 2 at time of inclusion (see Appendix IV )
Known IPI at time of diagnosis (prior to induction therapy)
Age 18 years or older
Life expectancy of at least 3 months
Be willing and able to comply with the protocol for the duration of the study
Women of child-bearing potential must have a negative pregnancy test and must agree to use effective contraception for the entire treatment period and during the 12 months thereafter.
Patient’s written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
First-line NHL therapy other than specified in the inclusion criteria
More than one prior chemoimmunotherapy regimen.
Histologies other than DLBCL and follicular lymphoma grade 3b according to the WHO/REAL classification
Transfomed lymphoma
History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin, surgically treated malignant melanoma or carcinoma in situ of the cervix within the last 5 years.
Major surgery, other than diagnostic surgery, within the last 4 weeks.
Evidence of CNS involvement. Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the Investigator to be clinically significant and adversely affecting compliance to study drugs.
Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months.
Unacceptable hematologic status at baseline prior to study start below any of the values listed: WBC: <3 x 109/L; absolute neutrophil count (segmented + bands) <1.5 x 109/L; platelets: <100 x109/L
Abnormal liver function tests prior to study start above any of the values listed: serum bilirubin >2 mg/dL (35 mmol/L); ALAT or ASAT >2.5 x upper limit of normal range; alkaline phosphatase > 3 x upper limit of normal range
Abnormal renal function (serum creatinine > 2.0 mg/dL (177 µmol/L)).
Patients with active opportunistic infections.
HIV-positive patients.
Life expectancy of less than 3 months.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method