E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Aggressive Non Hodgkin´s Lymphoma (NHL) |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Primary objective: To evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation in patients with aggressive B-cell Non-Hodgkins lymphoma or follicular lymphoma grade 3b who have achieved a complete remission after appropriate first-line therapy, measured by event-free survival (EFS)
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E.2.2 | Secondary objectives of the trial |
Secondary objective: To evaluate Progression-free Survival (PFS), Overall Survival (OS) and Safety. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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
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E.4 | Principal exclusion criteria |
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 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Event-free survival (EFS) defined as the time from randomization to progression, relapse, death from any cause, or instituition of new anti-lymphoma treatment |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |