A Phase II Study of Rituximab Combined With CHOP in T-cell Angio-immunoblastic Lymphoma

Study of the Efficacy and the Safety of First Line Treatment With CHOP Plus Rituximab (R-CHOP) in Patients Aged 60 to 80 Years With Previously Untreated T-cell Angioimmunoblastic Lymphoma (AIL).

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00169156

Enrollment

Registered

2005-09-15

Start date

2005-12-31

Completion date

2012-11-30

Last updated

2017-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Untreated T-cell Angioimmunoblastic Lymphoma

Keywords

T-cell angioimmunoblastic lymphoma, Rituximab

Brief summary

To evaluate the efficacy and the safety of a front-line treatment combining CHOP regimen and rituximab in patients aged 60 to 80 years with previously untreated AIL.

Detailed description

This is a multicentric, open-label, non-randomized clinical study, evaluating the efficacy and the safety of a front-line treatment combining CHOP regimen and rituximab in patients aged 60 to 80 years with previously untreated AIL. It is anticipated that 25 subjects will be enrolled over 2 years (from 2005 / 2007).Analysis performed every 5 patients (based on triangular test). The duration of the treatment period is approximately 25 weeks and patients are followed until Death. The total Duration of the study is expected to be 2.5 years.

Interventions

DRUGRituximab

375 mg/m2 D1

DRUGPrednisone

40 mg/m2 D1 to D5

DRUGDoxorubicine

50 mg/m2 D1

DRUGCyclophosphamide

750 mg/m2 D1

DRUGVincristine

1,4 mg/m2 D1

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Patients with histologically proven T-cell angioimmunoblastic lymphoma (AIL) on lymph node biopsy. * Aged from 60 to 80 years. * Patient not previously treated (except corticosteroids providing they have been initiated less than 10 days before inclusion). * ECOG performance status 0 to 2. * With a minimum of life expectancy \> 3 months. * Negative HIV, HBV and HCV serological tests \< 4 weeks (except after vaccination). * Having previously signed a written informed consent.

Exclusion criteria

* Any other histological type of T-cell lymphoma. * Central nervous system or meningeal involvement by lymphoma. * Contra-indication to any drug included in the R-CHOP regimen. * Concurrent severe disease (according to the investigator's decision). * Active bacterial, viral or fungal infection. * Poor renal function (serum creatinine level \> 150 µmol/L) or impaired liver function tests (total bilirubin level \> 30 µmol/L, transaminases \> 2.5 upper normal limits) unless they are related to the lymphoma. * Poor bone marrow reserve as defined by neutrophils \< 1.5 x 109/L or platelets \< 100 x 109/L, unless related to bone marrow infiltration. * Any history of cancer during the last 5 years, with the exception of non basal cell carcinoma of the skin or in situ carcinoma of the cervix. * Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study. * Patient under tutelage.

Design outcomes

Primary

Measure	Time frame	Description
Overall Response Rate (ORR)	8 months (4 cycles of treatment + 4 cycles of consolidation)	\[Complete response (CR), Complete response unconfirmed (CRu)\] after the end of treatment.

Secondary

Measure	Time frame	Description
Event-free survival (EFS) relapse for complete responders, disease progression, early discontinuation of treatment for toxicity or modification of treatment.	2 years	Events being death from any cause
Overall survival (OS)	2 years	—
Time to progression (TTF)	2 years	—
Disease-free survival (DFS).	2 years	—
number of SAE	2 years	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026