Efficacy , Safety of Treatment R NIMP for Relapsed Aggressive Lymphomas
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Purpose
The primary objective of the protocol is to estimate the complete response rate of three courses of the association of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone in relapsed aggressive non hodgkin's B-cell lymphoma
| Condition | Intervention | Phase |
|---|---|---|
|
B-cell Diffuse Large Cell Non Hodgkin's Lymphoma |
Drug: rituximab Drug: navelbine Drug: ifosfamide Drug: Mitoxantrone Drug: Prednisone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Treatment of Relapsed Agressive Lymphomas |
- Complete remission rate [ Time Frame: CR AFTER 3 R NIMP COURSES ] [ Designated as safety issue: Yes ]
- overall remission rate [ Time Frame: OS after 3 R NIMP COURSES ] [ Designated as safety issue: Yes ]
- Toxicity [ Time Frame: R NIMP TOLERANCE ] [ Designated as safety issue: Yes ]
- Pharmacoeconomy [ Time Frame: treatment phramacoeconomy ] [ Designated as safety issue: Yes ]
| Enrollment: | 50 |
| Study Start Date: | December 2003 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Phase II study of the efficacy and toxicity of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone in relapsed aggressive non hodgkin's B-cell lymphoma.
The study intervention is an administration of 3 courses of the abovementioned drugs, witch doses are detailed below. Remission is assessed and the investigator is free to proceed with any kind of consolidation , he decides best for the patient( high dose or standard chemotherapy).
The addition of Rituximab the the NIMP protocol is warranted on the basis of previous publications wtich have shown a significant advantage in addition to chemotherapy in complete remission rate and in overall survival.
Navelbine has shown an interesting activity in lymphoma relapse. Mitoxantrone has a good toxicity profile for patients who have prevously received anthracyclines, and there is not so much cross resistance between the two drugs.
Ifosfamide is commonly used in the treatment of relapsed and refractory lymphoma, because of its low hematologic toxicity profile and good antitumor activity.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Both genders, between 18 and 75 years old
- CD 20+ large cell lymphoma
- In first relapse
- No previous autologous stem cell transplantation or relapsing more than 12 months after an autologous stem cell transplantation
- Ann Arbor stage I, II, III ou IV
- ECOG 0,1 or 2
- Signed informed consent
Exclusion Criteria:
- age: before 18 and more than 75 years old
- other type of lymphoma
- Informed consent not signed
Contacts and Locations| France | |
| Hôpital COCHIN | |
| Paris, France, 75014 | |
| Principal Investigator: | Emmanuel GYAN | Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS |
More Information
Additional Information:
No publications provided
| Responsible Party: | Groupe est ouest Leucémies et autres maladies du sang, DR Emamnuel GYAN |
| ClinicalTrials.gov Identifier: | NCT00842595 History of Changes |
| Other Study ID Numbers: | R NIMP |
| Study First Received: | February 11, 2009 |
| Last Updated: | July 12, 2010 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:
|
relapsed aggressive B-cell lymphoma Chemotherapy |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Ifosfamide Isophosphamide mustard Vinorelbine Rituximab Mitoxantrone Prednisone Antineoplastic Agents, Alkylating |
Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 16, 2013