Indolent Cutaneous B Cell Lymphomas Clinical Trial
— RADIO-LYMPHOfficial title:
Multiple Fields Radiotherapy Versus Intravenous Rituximab in the Treatment of Indolent Cutaneous Lymphomas B-cell With Multiple or Recurrent Lesions
Cutaneous lymphomas are the most frequent extranodal lymphomas after digestive lymphomas. A
quarter are B-cell lymphomas. 80% of cutaneous B cell lymphomas are indolent cutaneous B
cell lymphomas. These indolent cutaneous B cell lymphomas are characterized by good
prognosis (survival rate at 5 years: 90%), but also by the frequency of cutaneous
recurrences. The radiotherapy is currently the most widely used treatment, with complete
response rate close to 100% for a lesion treated. However, it has limits when there are
outset multiple lesions inaccessible to a single radiotherapy field (concerning one case in
three), or during recurrences. In these situations, conventional chemotherapy is not
recommended and multi-field radiotherapy is often used empirically, but its effectiveness
has never been studied prospectively.
Recently, retrospective studies with small numbers patients (totaling sixty patients)
reported complete response rates of 80 to 100% with rituximab (anti-cluster of
differentiation antigen 20 (CD20) antibodies) used as monotherapy in non-standardized
treatment by intravenous with a recurrence rate of less than one case in three. These data
suggest that rituximab by intravenous with a standardized initial cycle followed by a
maintenance therapy could improve the prognosis of indolent cutaneous B cell lymphomas with
multiple lesions or of recurrent lesions.
| Status | Active, not recruiting |
| Enrollment | 36 |
| Est. completion date | January 2019 |
| Est. primary completion date | July 2018 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - patients with histological diagnosis of indolent cutaneous B cell lymphomas - patients with multiple lesions inaccessible to a single field of radiotherapy or patients with a recurrence outside the field of first radiotherapy - patient with a lesion of at least 15 mm in major axis and a total tumor surface area greater or egal than 4 cm2 - patient with a negative staging - patient consenting to participate to the study - patient enrolled in the national healthcare insurance program - patient older than 18 years Exclusion Criteria: - contraindication for rituximab or radiotherapy - immunosuppressive therapy - immunosuppression |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Chu de Reims | Reims |
| Lead Sponsor | Collaborator |
|---|---|
| CHU de Reims |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Disease free survival | Disease free survival | 5 years | No |