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R-COMP 14 in elderly patients with high grade non-Hodgkin lymphoma - R-COMP 14

R-COMP 14 in elderly patients with high grade non-Hodgkin lymphoma - R-COMP 14

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-005613-19-IT
Enrollment
Unknown
Registered
2008-05-08
Start date
2007-04-27
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Elderly patients with B non-Hodgkin lymphoma MedDRA version: 9.1 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell

Interventions

Trade Name: MYOCET Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Doxorubicin Concentration unit: mg milligram(s) Concentration type: equal Concentration number

Sponsors

AZIENDA OSPEDALIERA OSPEDALE S. SALVATORE
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Hystological diagnosis of B cell aggressive non-Hodgkin lymphoma, age>65 years, IPI>=1, stage >I, CD20 positivity, signed informed consent, HIV negativity Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: age<65 years, CD20 negativity, HIV positivity, patients not able to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the safety and the feasability of the R-COMP 14 and R-COMP 21 regimens;Secondary Objective: Overall response rate after R-COMP 14 or 21; progression free survival after R-COMP 14 or 21; overall survival after R_COMP 14 or 21; quality of life improvement after R-COMP 14 or 21;Primary end point(s): To evaluate the safety and the efficacy of RCOMP-14 and RCOMP-21 regimens—

Countries

Italy

Outcome results

None listed

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