Open Label, Single Arm, Phase II Study Using R-COMP in Elderly Patients With Aggressive NHL.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00244127
Recruitment Status : Unknown
Verified October 2005 by Zeneus Pharma.
Recruitment status was:  Active, not recruiting
First Posted : October 25, 2005
Last Update Posted : October 28, 2005
Information provided by:
Zeneus Pharma

Brief Summary:
To evaluate the safety and efficacy of R-COMP in elderly patients with advanced aggressive NHL. Myocet (non-pegylated liposomal doxorubicin) replaces conventional doxorubicin in the R-CHOP regimen.

Condition or disease Intervention/treatment Phase
Aggressive Non-Hodgkin's Lymphoma in the Elderly. Drug: Cyclophosphamide, oncovin, myocet, prednisone & rituximab (R-COMP) Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cyclophosphamide, Oncovin, Myocet, Prednisone and Rituximab (R-COMP) in the Treatment of Elderly Patients With Aggressive NHL.
Study Start Date : October 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Primary Outcome Measures :
  1. Response rate

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 lymphoma);
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00244127

Paris, France
Berlin, Germany
Universita Degli Studi Di Modena AZ Ospedaliere Policlinico
Modena, Italy, 41100
Barcelona, Spain
United Kingdom
Leicester, United Kingdom
Sponsors and Collaborators
Zeneus Pharma
Principal Investigator: Massimo Federico Universita Degli Studi di Modena Identifier: NCT00244127     History of Changes
Other Study ID Numbers: Myocet 018
The MYOCAN Study
First Posted: October 25, 2005    Key Record Dates
Last Update Posted: October 28, 2005
Last Verified: October 2005

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Behavioral Symptoms
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic