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

Sponsor

Lymphoma Study Association (Other)

Overall Status

Completed

CT.gov ID

NCT00169156

Collaborator

Hoffmann-La Roche (Industry)

Enrollment

Locations

Arm

Actual Duration (Months)

6.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Untreated T-cell Angioimmunoblastic Lymphoma	Drug: Rituximab Drug: Prednisone Drug: Doxorubicine Drug: Cyclophosphamide Drug: Vincristine	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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).

Actual Study Start Date :

Dec 1, 2005

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rituximab + CHOP Rituximab + CHOP regimen Prednisone - Doxorubicine - Cyclophosphamide - Vincristine	Drug: Rituximab 375 mg/m2 D1 Drug: Prednisone 40 mg/m2 D1 to D5 Drug: Doxorubicine 50 mg/m2 D1 Drug: Cyclophosphamide 750 mg/m2 D1 Drug: Vincristine 1,4 mg/m2 D1

Arm

Intervention/Treatment

Experimental: Rituximab + CHOP

Rituximab + CHOP regimen Prednisone - Doxorubicine - Cyclophosphamide - Vincristine

Drug: Rituximab

375 mg/m2 D1

Drug: Prednisone

40 mg/m2 D1 to D5

Drug: Doxorubicine

50 mg/m2 D1

Drug: Cyclophosphamide

750 mg/m2 D1

Drug: Vincristine

1,4 mg/m2 D1

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hôpital Henri Mondor	Créteil	France
2	Hôpital Saint Louis	Paris	France
3	Service d'Hématologie - Centre Hospitalier Lyon-Sud	Pierre-Bénite cedex	France	69495
4	Centre Henri Becquerel	Rouen	France

Sponsors and Collaborators

Lymphoma Study Association
Hoffmann-La Roche

Investigators

Study Chair: Corinne Haioun, MD, Hôpital Henri Mondor, Créteil, France
Principal Investigator: Bertrand Joly, MD, C.H. Sud Francilien, Corbeil-Essonnes, France