Clinical trial to evaluate R-COMP versus R-CHOP in newly diagnosed patients with non-localised diffuse large B-cell lymphoma (DLBCL)/follicular lymphoma grade IIIb.
- Conditions
- on-localised diffuse large B-cell lymphoma/Follicular lymphoma grade IIIbTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2013-001065-17-ES
- Lead Sponsor
- Grupo Español de Linfomas/Trasplante Autólogo de Médula Ósea (GEL/TAMO)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
1.? 60 years of age
2.Histological confirmed DLBCL/follicular lymphoma grade IIIb by WHO classification, with any IPI (International Prognostic Index)
3.Newly diagnosed, with no previous treatment
4.Non-localised stage, i.e. lymphoma that does not fit into a single radiotherapy field (including clinical stage IA with large tumour mass until stage IV) with at least one measurable lesion
5.ECOG performance status 0 to 2
6.Present appropriate haematologic, liver (ALT or AST < 2.5 ULN ? upper limit of normal) and renal functions (creatinine < 2.5 ULN) , unless changes are secondary to lymphoma
7.LVEF at rest ? 55%, with no documented history of congestive heart failure (CHF), serious arrhythmia or acute myocardial infarction
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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90
1.Clinical stage I without large tumour mass or clinical stage IIA with fewer than three affected areas (stage-IIB patients are considered suitable, regardless of the number of affected areas)
2.CNS infiltration
3.Transformed lymphoma, although with no previous treatment, as well as other histological subtypes such as mantle cell lymphoma, peripheral T-cell lymphoma and its variants and post-transplant lymphoproliferative syndrome
4.Clinically significant secondary cardiovascular disease
5.Signs of any severe, acute or chronic and active infection
6.Concurrent malignancy or history of other neoplasia except basal cell carcinoma (BCC) and cervical or breast carcinoma in situ (CIN)
7.Patients with positive results in the HBV, HIV or HCV RNA tests
8.Any previous treatment for DLBCL/follicular lymphoma grade IIIb
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