E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients 60 - 80 years old with newly diagnosed non cutanous, non leukemic Peripheral T- Cell lymphoma, except alk-protein positive anaplastic large cell lymphoma. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10042971 |
E.1.2 | Term | T-cell lymphoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
Comparison of +/- alemtuzumab addition concerning: further endpoints of efficacy, short term and long term side effects, adherence to protocol and withdrawal from therapy |
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E.2.2 | Secondary objectives of the trial |
The secondary aims of the study are to collect further data in order to be able to evaluate
1. Efficacy: - rate of complete remission
- overall response rate
- rate of primary progression
- relapse rate
- rate of treatment-related deaths
- overall survival
- progression-free survival
- tumour control
- disease-free survival.
2. Safety
3. Adherence to protocol
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
. Age: 61 - 80 years
2. Risk group: All risk groups, including stage I with bulk (≥ 7.5 cm) and stages II to IV, exept stage I with no further IPI risk factor (LDH, ECOG, stage, E>1) beside the age over 60
3. Histology: Diagnosis of aggressive non-Hodgkin's lymphoma, confirmed by an excisional biopsy of a lymph node or by a sufficiently extensive biopsy of an extranodal involvement if there is no lymph node involvement. It will be possible to treat all peripheral T-lineage lymphomas with the exception of ALK-positive anaplastic large cell lymphoma and primary cutaneous T-cell lymphomas (Mycosis fungoides, Sezary syndrome and primary cutaneous CD30-positive lymphoproliferations, and transformed primary cutaneous T-cell lymphomas). These lymphomas comprise:
T cell -NHL:
peripheral T-cell lymphoma PTCL-NOS
Lennert's lymphoma
T-zone lymphoma
T-cell lymphoma of the AILD type
anaplastic large cell lymphoma
ALK-
extranodal NK/T-cell lymphoma, nasal type
intestinal T/NK-cell lymphoma (± enteropathy)
hepatosplenic gamma-delta lymphoma
subcutaneous panniculitis-like PTCL
4. Performance status: Performance status ECOG 0 - 2 (Karnofsky index: 60 - 100%). The general status of each patient is to be assessed at time of randomisation and can thus take place after initiation of prephase treatment. A performance status of ECOG 3 will allow inclusion, if it is lymphoma related. The pretreatment status is to be documented in the staging CRF; the performance after the prephase treatment is also to be documented in the relevant CRF for the prephase treatment (see Appendix). A definition of the performance status is provided in the Appendix.
5. Declaration of center participation
6. written consent of the patient
7. measurable disease defined as at least one lesion with two measurable perpendicular diameters of which at least one should be ³15 mm
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E.4 | Principal exclusion criteria |
Stage I with IPI 0 and without bulk
2. Already initiated lymphoma therapy (except for the prephase treatment specified for this study)
3. Serious accompanying disorder or impaired organ function, in particular:
- Cardiac: angina pectoris CCS >2, cardiac failure NYHA >2 and/or EF <45% or FS<25% in echocardiography/nuclear medicine examination
- Pulmonary: abnormal blood gases; in this case, the patient is to be excluded if the resultant pulmonary function test shows FeV1<50% or a diffusion capacity <50% of the reference values
- Renal: creatinine >2 times the upper reference limit, unless related to NHL
- Hepatic: bilirubin >2 times the upper reference limit, unless related to NHL
- Uncontrollable diabetes mellitus (prephase treatment with prednisone!)
4. Platelets <100 000/mm3, leukocytes <2500/mm3
5. Bone marrow involvement >25%
6. Primary leukemic manifestation of the lymphoma
7. Known hypersensitivity to the medications to be used, especially murine or chimeric antibodies
8. Known HIV-positivity
9. Active hepatitis infection, active CMV infection, active systemic fungal infection, active infection with mycobacterium tuberculosis or atypical tuberculosis
10. Suspicion that patient compliance will be poor
11. Simultaneous participation in any other study protocol
12. Prior chemo- or radiotherapy for malignancy
13. Other concomitant malignant disease (history of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma)
14. Non-conformity to eligibility criteria
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end point of this study is Event-free Survival (EFS). The Kaplan-Meier method will be used to assess EFS. EFS is defined by the time between day of randomisation until one of the following events occurs, whichever comes first:
(a) Disease progression during therapy (PD)
(b) Institution of any additional unplanned anti-tumor treatment
(c) Relapse after achievement of CR/CRu
(d) Death due to any cause.
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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 | No |
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 | No |
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.8.5.1 | Number of sites anticipated in the EEA | 80 |
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 | Yes |
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 patient in for therapy Sep 2013; last patient out of follow-up Mar 2016 |
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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 | 9 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 9 |