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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2005 by Zeneus Pharma.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Zeneus Pharma
ClinicalTrials.gov Identifier:
NCT00244127
First received: October 24, 2005
Last updated: October 26, 2005
Last verified: October 2005
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cyclophosphamide, Oncovin, Myocet, Prednisone and Rituximab (R-COMP) in the Treatment of Elderly Patients With Aggressive NHL.

Resource links provided by NLM:


Further study details as provided by Zeneus Pharma:

Primary Outcome Measures:
  • Response rate

Estimated Enrollment: 75
Study Start Date: October 2002
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00244127

Locations
France
Paris, France
Germany
Berlin, Germany
Italy
Universita Degli Studi Di Modena AZ Ospedaliere Policlinico
Modena, Italy, 41100
Spain
Barcelona, Spain
United Kingdom
Leicester, United Kingdom
Sponsors and Collaborators
Zeneus Pharma
Investigators
Principal Investigator: Massimo Federico Universita Degli Studi di Modena
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00244127     History of Changes
Other Study ID Numbers: Myocet 018, The MYOCAN Study
Study First Received: October 24, 2005
Last Updated: October 26, 2005
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Ministry of Health and Consumption
Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on November 20, 2014