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.

Phase II, randomised, multicentre study with two treatment arms (R-COMP versus R-CHOP) in newly diagnosed elderly patients (?60 years) with non-localised diffuse large B-cell lymphoma (DLBCL)/follicular lymphoma grade IIIb.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001065-17-ES

Enrollment

Registered

2013-06-10

Start date

2013-08-01

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-localised diffuse large B-cell lymphoma/Follicular lymphoma grade IIIb

Interventions

Trade Name: Myocet 50 mg polvo y premezclas concentrado para dispersión liposómica para perfusión Pharmaceutical Form: Concentrate for dispersion for infusion INN or Proposed INN: DOXORUBICIN CAS Numb

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 90

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Main Objective: ?To assess reduced of subclinical cardiotoxicity, determined by differences in LVEF, which involves the incorporation of non-pegylated liposomal doxorubicin (Myocet®) when replacing conventional doxorubicin in the standard R-CHOP regimen (R-COMP) to treat newly diagnosed elderly patients with non-localised DLBCL/follicular lymohoma grade IIIb;Secondary Objective: ? To assess event-free survival, progresion free survival and overall survival at 2 and 5 years after the end of the study treatment in both treatment arms. ? To determine the overall response rate and complete remissions in patients treated with R-CHOP and R-COMP. ? To assess clinical cardiovascular events according to the CTC criteria (version 4.0) of the NCI in both patient groups. ? To determine non-cardiac toxicity according to the CTC criteria (version 4.0) of the NCI in both patient groups. ? To determine and compare the values of troponin, NT-proBNP and LVEF, and establish their correlation with clinical and subclinical cardiotoxicity in both treatment arms.;Primary end point(s): ? Subclinical cardiac toxicity determined by the percentage of patients experiencing a decrease in LEVF determined by echocardiography with final LEVF <55% 30 days after the end of the study treatment;Timepoint(s) of evaluation of this end point: 30 days after the end of the study treatment	—

Measure

Time frame

Main Objective: ?To assess reduced of subclinical cardiotoxicity, determined by differences in LVEF, which involves the incorporation of non-pegylated liposomal doxorubicin (Myocet®) when replacing conventional doxorubicin in the standard R-CHOP regimen (R-COMP) to treat newly diagnosed elderly patients with non-localised DLBCL/follicular lymohoma grade IIIb;Secondary Objective: ? To assess event-free survival, progresion free survival and overall survival at 2 and 5 years after the end of the study treatment in both treatment arms. ? To determine the overall response rate and complete remissions in patients treated with R-CHOP and R-COMP. ? To assess clinical cardiovascular events according to the CTC criteria (version 4.0) of the NCI in both patient groups. ? To determine non-cardiac toxicity according to the CTC criteria (version 4.0) of the NCI in both patient groups. ? To determine and compare the values of troponin, NT-proBNP and LVEF, and establish their correlation with clinical and subclinical cardiotoxicity in both treatment arms.;Primary end point(s): ? Subclinical cardiac toxicity determined by the percentage of patients experiencing a decrease in LEVF determined by echocardiography with final LEVF <55% 30 days after the end of the study treatment;Timepoint(s) of evaluation of this end point: 30 days after the end of the study treatment

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Secondary

Measure	Time frame
Secondary end point(s): ? Event free survial, progression free survival and overall survival at 2 and 5 years after the end of the study treatment. ? Overall response rates and complete responses evaluated by the International Harmonization Project for response criteria in lymphoma. ? Rate of cardiac/cardiovascular toxicity according to the CTC criteria (version 4.0) of the National Cancer Institute (NCI) during the treatment and during 5 years after the end of the study treatment. ? No cardiotoxicity according to the CTC criteria (version 4.0) of the NCI during the tratment and during 24 months after the end of the study treatment. ? Cardiotoxicity determined by elevated values of troponin and NT-proBNP and decreased values of LEVF determined during the treatment and during 12 months after the end of the study treatment;Timepoint(s) of evaluation of this end point: During the study treatment, at the end of the study tretament and12 months, 24 months and 5 years after the end of the studyr treatment	—

Measure

Time frame

Secondary end point(s): ? Event free survial, progression free survival and overall survival at 2 and 5 years after the end of the study treatment. ? Overall response rates and complete responses evaluated by the International Harmonization Project for response criteria in lymphoma. ? Rate of cardiac/cardiovascular toxicity according to the CTC criteria (version 4.0) of the National Cancer Institute (NCI) during the treatment and during 5 years after the end of the study treatment. ? No cardiotoxicity according to the CTC criteria (version 4.0) of the NCI during the tratment and during 24 months after the end of the study treatment. ? Cardiotoxicity determined by elevated values of troponin and NT-proBNP and decreased values of LEVF determined during the treatment and during 12 months after the end of the study treatment;Timepoint(s) of evaluation of this end point: During the study treatment, at the end of the study tretament and12 months, 24 months and 5 years after the end of the studyr treatment

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Countries

Spain

Contacts

Public ContactÁngel Pérez

Dynamic Solutions

a.perez@dynasolutions.com+34933511615

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 21, 2026