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CHOEP-14 + rituximab with CNS prophylaxis in patients less than 65 years with Diffuse Large B-Cell Lymphoma/Follicular Lymphoma grade III, stage II-IV with risk factors (age adjusted IPI) = 2. A phase II study (NLG-LBC-04)

CHOEP-14 + rituximab with CNS prophylaxis in patients less than 65 years with Diffuse Large B-Cell Lymphoma/Follicular Lymphoma grade III, stage II-IV with risk factors (age adjusted IPI) = 2. A phase II study (NLG-LBC-04)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-003075-37-FI
Enrollment
150
Registered
2004-09-28
Start date
2004-12-20
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

18-64 year old patients having primary diffuse large B-cell lymphoma (DLBCL) with risk factors (age adjusted IPI=2), or follicular lymphoma grade III

Interventions

Trade Name: Mabthera Product Name: Rituximab Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: rituksimabi Other descriptive name: anti-CD20 antibody Concentration unit:
2. Syklofosfamid Product Name: Cyclophosphamide Pharmaceutical Form: Powder for infusion* INN or Proposed INN: syklofosfamidi Other descriptive name: C Concentration unit: mg/m2 milligram(s)/square me
2. Etoposide
3. Vepesid Product Name: etoposide Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: etoposidi Other descriptive name: E Concentration unit: mg/m2 milligram(s)/square met
2. Trexan Product Name: Metotrexate Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: metotreksaatti Oth

Sponsors

Nordic Lymphoma Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age = 18 - =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Severe cardiac disease (i.e. heart failure, Cardiac function grade III - IV or Left Ventricular Ejection Fraction (LVEF) < 45%. 2. Impaired liver, renal or other organ function not caused by lymphoma and which will interfere with the treatment schedule. 3. Pregnancy. 4. Men and women of reproductive potential not agreeing to use an acceptable method of birth control during treatment and for six months after completion of treatment. 5. Patients with other severe medical problems and with an expected short survival for non-lymphoma reasons. 6. Known HIV positivity. 7. Present or previous cancer except basal cell carcinoma and cervical carcinoma in situ. 8. Uncontrolled infectious disease. 9. Psychiatric or mental disorder which make the patient unable to give an informed consent and/or adhere to the protocol.

Design outcomes

Primary

MeasureTime frame
Main Objective: To improve time to treatment failure in young high risk DLBCL patients;Secondary Objective: To investigate Toxicity Clinical response rate Time to progression Overall survival Incidence of CNS relapse Molecular factors important for clinical outcome;Primary end point(s): To study Time to Treatment Failure (TTF) from time of registration—

Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026