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

Sponsor
Zeneus Pharma (Industry)
Overall Status
Unknown status
CT.gov ID
NCT00244127
Collaborator
(none)
75
5
15

Study Details

Study Description

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
  • 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 Design

Study Type:
Interventional
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 :
Oct 1, 2002

Outcome Measures

Primary Outcome Measures

  1. Response rate []

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Paris France
2 Berlin Germany
3 Universita Degli Studi Di Modena AZ Ospedaliere Policlinico Modena Italy 41100
4 Barcelona Spain
5 Leicester United Kingdom

Sponsors and Collaborators

  • Zeneus Pharma

Investigators

  • Principal Investigator: Massimo Federico, Universita Degli Studi di Modena

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00244127
Other Study ID Numbers:
  • Myocet 018
  • The MYOCAN Study
First Posted:
Oct 25, 2005
Last Update Posted:
Oct 28, 2005
Last Verified:
Oct 1, 2005
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 28, 2005