A Study of Two Associations of Rituximab and Chemotherapy, With a PET-driven Strategy, in Lymphoma (LNH2007-3B)
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Purpose
This Phase II study randomized R-ACVBP and R-CHOP as induction treatment in patients from 18 to 59 with DLBCL CD20+ lymphoma and 2 or 3 adverse prognostic factors of the age-adjusted IPI. The consolidation treatment is allocated according to the response to induction treatment assessed by PET after the 2nd and 4th induction cycles.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, B-Cell Lymphoma, Large-Cell, Diffuse |
Drug: R-CHOP14 induction regimen Drug: R-ACVBP14 induction regimen |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Phase II Study of Two Associations of Rituximab and Chemotherapy, With a PET -Driven Strategy, in Patients From 18 to 59 With DLBCL CD20+ Lymphoma and 2 or 3 Adverse Prognostic Factors of the Age-adjusted IPI |
- Complete response rate after 4 inductive cycles with R-ACVBP14 or R-CHOP14, in DLBCL CD 20 (+) patients, presenting with 2 or 3 adverse prognostic factors of the aa-IPI Test a Pet-driven strategy Complete response rate after the 4 inductive cycles [ Time Frame: 4 inductive cycles with R-ACVBP14 or R-CHOP14 ] [ Designated as safety issue: Yes ]
- Response according to PET after 2 cycles, 4 cycles Induction toxicities Response duration Disease-, progression-, event-free and overall survival after autologous transplant Biological factors for prognosis Pharmacokinetic of rituximab [ Time Frame: 2 cycles and 4 cycles Induction ] [ Designated as safety issue: Yes ]
| Enrollment: | 222 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: R-CHOP-14
R-CHOP14 induction regimen
|
Drug: R-CHOP14 induction regimen
R-CHOP14 induction regimen
|
|
Experimental: R-ACVBP14
R-ACVBP14 induction regimen
|
Drug: R-ACVBP14 induction regimen
R-ACVBP14 induction regimen
|
Detailed Description:
1) Induction Arm A: 4 cycles of R-ACVBP, 2 weeks interval. After the 3rd cycle, if PET 2+ (fixing), collection of peripheral blood stem cell progenitors will be organized at the time of hematological recovery under support with G-CSF.
The consolidation treatment will depend on results of PET evaluation after cycle 2 (PET2) and cycle 4 (PET4).
Consolidation 1A (in case of PET 2- PET 4 -):
- High-dose Methotrexate with folinic acid rescue; 2 cycles spaced out 14 days.
- Rituximab-Ifosfamide-Etoposide : 4 cycles spaced out 14 days
- Cytarabine sub-cutaneous, during 4 days; 2 cycles spaced out 14 days.
Consolidation 2 A (in case of PET 2+ PET4 -):
- 2 cycles high-dose Methotrexate with folinic acid rescue
- High dose with Z- BEAM conditioning regimen followed by autologous transplant.
- Salvage(in case of PET 4 +):
The patient will be treated with a salvage regimen, after a biopsy of the residual mass whenever possible.
2) Induction arm B: 4 cycles of R-CHOP, 2 weeks interval. After the 3rd cycle, if PET 2+ (fixing), collection of peripheral blood stem cell progenitors will be organized at the time of hematological recovery under support with G-CSF.
The consolidation treatment will depend on results of PET evaluation after cycle 2 (PET2) and cycle 4 (PET4).
Consolidation 1B(in case of PET 2- PET 4 -):
4 additional cycles of R-CHOP, 2-weeks interval
Consolidation 2 B(in case of PET 2+ PET 4 -):
- 2 cycles high-dose Methotrexate with folinic acid rescue
- High dose with Z- BEAM conditioning regimen followed by autologous transplant
- Salvage(in case of PET 4 +):
The patient will be treated with a salvage regimen, after a biopsy of the residual mass whenever possible
Eligibility| Ages Eligible for Study: | 18 Years to 59 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient with histologically proven CD20+ diffuse large B-cell lymphoma (WHO classification).
- Age from18 to 59 years, eligible for transplant.
- Patient not previously treated.
- Baseline FDG-PET Scan (PET0) performed before any treatment with at least one hypermetabolic lesion.
- Index prognostic factors (IPI) 2 or 3.
- With a minimum life expectancy of 3 months.
- Negative HIV, HBV and HCV serologies £ 4 weeks (except after vaccination).
- Having previously signed a written informed consent.
Exclusion Criteria:
- Any other histological type of lymphoma.
- Any history of treated or non-treated indolent lymphoma. However, patients not previously diagnosed and having a diffuse large B-cell lymphoma with some small cell infiltration in bone marrow or lymph node may be included.
- Central nervous system or meningeal involvement by lymphoma.
- Contra-indication to any drug contained in the chemotherapy regimens.
- Poor renal function (creatinin level >150 mmol/l), poor hepatic function (total bilirubin level >30 mmol/l, transaminases >2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
- Poor bone marrow reserve as defined by neutrophils <1.5 G/l or platelets <100 G/l, unless related to bone marrow infiltration.
- Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ)cervical carcinoma.
- Any serious active disease (according to the investigator's decision).
- Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy.
- Pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception
- Adult patient under tutelage.
- Impossibility to performed a baseline PET scan (PET0) before randomization and treatment beginning
Contacts and Locations More Information
Additional Information:
No publications provided by Hospices Civils de Lyon
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bertrand COIFFIER, Service d'Hématologie clinique et Oncologie médicale - Centre Hospitalier Lyon-Sud - 69495 Pierre-Bénite - France |
| ClinicalTrials.gov Identifier: | NCT00498043 History of Changes |
| Other Study ID Numbers: | 2007.462 |
| Study First Received: | July 5, 2007 |
| Last Updated: | July 21, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Hospices Civils de Lyon:
|
Lymphoma PET Chemotherapy Rituximab |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Lymphoma, Non-Hodgkin Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 18, 2013