A Study of Two Associations of Rituximab and Chemotherapy, With a PET-driven Strategy, in Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2013-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Patients With Diffuse Large B-cell Lymphoma and Age-adjusted IPI of 1

NCT00140595

Diffuse Large-Cell Lymphoma

COMPLETED PHASE3

ACVBP Plus Rituximab in Patients Aged From 18 to 59 Years With High-risk Diffuse Large B-cell Lymphoma

NCT00144807

Diffuse Large Cell Lymphoma

COMPLETED PHASE2

R-ACVBP Versus R-CHOP in Patients Aged 60-65 With Diffuse Large B-cell Lymphoma

NCT00135499

Lymphoma, Large-Cell, Diffuse

TERMINATED PHASE3

ACVBP Versus ACVBP Plus Rituximab in Low Risk Localized Diffuse Large B-cell Lymphoma

NCT00140660

Diffuse Large Cell Lymphoma

TERMINATED PHASE3

Dose Dense Chemotherapy + Rituximab +/-Intensified High Dose Chemoimmunotherapy With Support of Peripheral Autologous Stem Cell in Diffuse Large B-Cell Lymphoma

NCT00499018

Diffuse Large B-Cell Lymphoma IPI≥2

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lymphoma, B-Cell Lymphoma, Large-Cell, Diffuse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

R-CHOP-14

R-CHOP14 induction regimen

Group Type EXPERIMENTAL

R-CHOP14 induction regimen

Intervention Type DRUG

R-CHOP14 induction regimen

R-ACVBP14

R-ACVBP14 induction regimen

Group Type EXPERIMENTAL

R-ACVBP14 induction regimen

Intervention Type DRUG

R-ACVBP14 induction regimen

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

R-CHOP14 induction regimen

Intervention Type DRUG

R-ACVBP14 induction regimen

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No