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Cyclophosphamide, Oncovin, Myocet, Prednisone and Rituximab (R-COMP) in the Treatment of Elderly Patients With Aggressive NHL.

Phase 2
65 Years
Open (Enrolling)
Aggressive Non-Hodgkin's Lymphoma in the Elderly.

Thank you

Trial Information

Cyclophosphamide, Oncovin, Myocet, Prednisone and Rituximab (R-COMP) in the Treatment of Elderly Patients With Aggressive NHL.

To evaluate the duration of remission, disease free survival and 2-year survival of R-COMP
in first line therapy of elderly patients with advanced aggressive NHL.

To evaluate the tolerability of R-COMP in first line therapy of elderly patients with
advanced aggressive NHL.

Inclusion Criteria:

- Diffuse Large B-Cell Lymphoma (DLBCL), and their morphologic variants and subtypes,
i.e. Centroblastic lymphoma, Immunoblastic lymphoma, T-cell rich/B-cell lymphoma,
anaplastic large B-cell lymphoma, mediastinal (thymic) large B-cell lymphoma;

- Primary diffuse large B-cell lymphoma of MALT (incorrectly defined as high-grade MALT

- Marginal zone B-cell lymphoma with coexisting areas of DLBCL;

- Age of ≥60 years;

- Clinical stage at diagnosis: I A bulky – IV B;

- CD20 positivity;

- Serum negativity for HbsAg and HCV except for those with no sign of active viral
replication, assessed by HCV-RNA copies;

- Absolute neutrophil count (ANC) ≥1.5x109/L, and platelet count ≥100x109/L (unless
both are attributed directly to bone marrow involvement by lymphoma or auto-immune
disease secondary to lymphoma);

- Serum creatinine ≤130μM/L, serum bilirubin ≤2.5xULN aspartate amino-transferase
(AST/GOT), ≤2.5xULN alanine amino-transferase (ALT/GPT) ≤2.5xULN, and alkaline
phosphatase ≤4 times the upper limit of normal (unless the increase is attributed
directly to the presence of tumour by the Investigator)

- Left ventricular ejection fraction (LVEF) ≥50%;

- ECOG performance status 0-2;

- At least one measurable lesion is mandatory;

- Written informed consent given at time of registration;

- Males and females (both males and females of childbearing potential must agree to use
adequate contraception for the duration, and for 3 months after the completion, of
the treatment).

Exclusion Criteria:

- Clinical stage I non-bulky, or CS IIA with less than three sites of disease involved
(patients with stage IIB are eligible, regardless of the number of sites involved);

- Tumour involvement of CNS;

- Indolent lymphoma transformed in more aggressive histological type, even if never
previously treated;

- Mantle Cell Lymphoma, Peripheral T cell Lymphoma and their variants;

- Aggressive non-Hodgkin’s lymphoma in transplanted patient;

- Clinically significant secondary cardiovascular disease, e.g. uncontrolled
hypertension, (resting diastolic blood pressure >115 mmHg), uncontrolled multifocal
cardiac arrhythmias, symptomatic angina pectoris or congestive cardiac failure NYHA
class III-IV;

- Evidence of any severe active acute or chronic infection;

- Concurrent malignancy or history of other malignancy, except basal cell carcinoma of
the skin (BCC) and in-situ cervical carcinoma (CIN) / Myelodysplastic syndrome;

- HbsAg, HIV-positive, or HCV-RNA-positive patients;

- Inability to comply with study procedures;

- Prior CNS lymphoma;

- Prior radiation to non-CNS lymphoma mass(es) as a treatment for lymphomas;

- History of allergic reaction to anthracyclines, eggs, and egg products or known
sensitivities, or history of unusual reaction, to other components of, or treatments
similar to, the investigational treatment regimen;

- Presence of other medication that may interfere with study treatment or the action of
the investigational product or confuse the assessment of study results

- Pregnant women or nursing mothers;

- Participation in an investigational drug study within 4 weeks prior to study entry.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Principal Investigator

Massimo Federico

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universita Degli Studi di Modena


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

Myocet 018



Start Date:

October 2002

Completion Date:

Related Keywords:

  • Aggressive Non-Hodgkin's Lymphoma in the Elderly.
  • Aggression
  • Lymphoma
  • Lymphoma, Non-Hodgkin