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
Recruitment status was Active, not recruiting
Sponsor:
Zeneus Pharma
Information provided by:
Zeneus Pharma
ClinicalTrials.gov Identifier:
NCT00244127
First received: October 24, 2005
Last updated: October 26, 2005
Last verified: October 2005
Tracking Information | |||||
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First Received Date ICMJE | October 24, 2005 | ||||
Last Updated Date | October 26, 2005 | ||||
Start Date ICMJE | October 2002 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
Response rate | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00244127 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Open Label, Single Arm, Phase II Study Using R-COMP in Elderly Patients With Aggressive NHL. | ||||
Official Title ICMJE | Cyclophosphamide, Oncovin, Myocet, Prednisone and Rituximab (R-COMP) in the Treatment of Elderly Patients With Aggressive NHL. | ||||
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. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Aggressive Non-Hodgkin's Lymphoma in the Elderly. | ||||
Intervention ICMJE | Drug: Cyclophosphamide, oncovin, myocet, prednisone & rituximab (R-COMP) | ||||
Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Enrollment ICMJE | 75 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 65 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | France, Germany, Italy, Spain, United Kingdom | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00244127 | ||||
Other Study ID Numbers ICMJE | Myocet 018, The MYOCAN Study | ||||
Has Data Monitoring Committee | |||||
Responsible Party | |||||
Study Sponsor ICMJE | Zeneus Pharma | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Zeneus Pharma | ||||
Verification Date | October 2005 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |