Treatment of Disseminated High Grade Lymphoma
Overview[ - collapse ][ - ]
| Purpose | Interest of the use of pegylated liposomal doxorubicin (caélyx) |
|---|---|
| Condition | Lymphoma |
| Intervention | Drug: Doxorubicin Drug: Doxorubicin pegylated |
| Phase | Phase 2/Phase 3 |
| Sponsor | Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS |
| Responsible Party | Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS |
| ClinicalTrials.gov Identifier | NCT00536393 |
| First Received | September 26, 2007 |
| Last Updated | October 31, 2007 |
| Last verified | September 2007 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 26, 2007 |
|---|---|
| Last Updated Date | October 31, 2007 |
| Start Date | October 2000 |
| Estimated Primary Completion Date | October 2004 |
| Current Primary Outcome Measures | hematologic toxicity [Time Frame: 6 months] |
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| Brief Title | Treatment of Disseminated High Grade Lymphoma |
|---|---|
| Official Title | Phase III Study of Treatment of Disseminated and Agressive Lymphoma R CHOP Versus R CLOP( With Liposomal Doxorubicin) |
| Brief Summary | Interest of the use of pegylated liposomal doxorubicin (caélyx) |
| Detailed Description | R CHOP is a good standard in the treatment of diffuse high grade lymphoma. Howeverin elderly patients it is often toxic, specially with haematologic and cardiac toxicities. |
| Study Type | Interventional |
| Study Phase | Phase 2/Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Lymphoma |
| Intervention | Drug: Doxorubicin Drug: Doxorubicin pegylated |
| Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 100 |
| Estimated Completion Date | October 2004 |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | Inclusion Criteria: - high grade lymphoma - disseminated - > 60 years old and < 75 - informed consent signed - cardiac state compatible with antracyclin - ECOG Exclusion Criteria: - patients > 75 years old - Cardiac insufficiency |
| Gender | Both |
| Ages | 60 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | France |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00536393 |
|---|---|
| Other Study ID Numbers | GOELAMS 0804 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS |
| Study Sponsor | Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Guillaume CARTRON, Dr Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS |
| Verification Date | September 2007 |
Locations[ + expand ][ + ]
| Clinique Victor Hugo | Le Mans, France, 72015 |
|---|