Diffuse Large B-Cell Lymphoma
Conditions
Keywords
relapsed aggressive B-cell lymphoma, Chemotherapy
Brief summary
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
Detailed description
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.
Interventions
DRUGrituximab
6 courses every 28 days
DRUGvinorelbine
6 courses every 28 days
DRUGifosfamide
6 courses every 28 days
DRUGMitoxantrone
6 courses every 28 days
DRUGPrednisone
6 courses every 28 days
Sponsors
French Innovative Leukemia Organisation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate | CR AFTER 3 R NIMP COURSES |
Secondary
| Measure | Time frame |
|---|---|
| overall remission rate | OS after 3 R NIMP COURSES |
| Toxicity | R NIMP TOLERANCE |
| Pharmacoeconomy | treatment phramacoeconomy |
Countries
France
Outcome results
None listed