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Multiple Fields Radiotherapy Versus Intravenous Rituximab in the Treatment of Indolent Cutaneous Lymphomas B-cell With Multiple or Recurrent Lesions (RADIO-LYMPH)

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ClinicalTrials.gov Identifier: NCT02867553
Recruitment Status : Active, not recruiting
First Posted : August 16, 2016
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Indolent Cutaneous B Cell Lymphomas Drug: rituximab Radiation: Multi-fields radiotherapy Phase 3

Detailed Description:
Compare the efficacy and safety of two treatment strategies for indolent cutaneous B cell lymphomas with multiple or recurrent lesions: Rituximab by intravenous versus multi-field radiotherapy.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multiple Fields Radiotherapy Versus Intravenous Rituximab in the Treatment of Indolent Cutaneous Lymphomas B-cell With Multiple or Recurrent Lesions
Study Start Date : October 2011
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: Rituximab by intravenous
attack treatment (4 slow intravenous perfusions of rituximab at a dose of 375 mg / m2 on day 1, day 8, day 15 and day 22) and maintenance treatment (intravenous perfusions of rituximab at a dose of 375 mg / m2 every 2 months for 2 years).
Drug: rituximab
Active Comparator: multi-field radiotherapy
multi-fields radiotherapy with a dose between 20 and 30 gray and a fractionated dose over 2 at 3 weeks.
Radiation: Multi-fields radiotherapy



Primary Outcome Measures :
  1. Disease free survival [ Time Frame: 5 years ]
    Disease free survival



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867553


Locations
France
Chu de Reims
Reims, France, 51092
Sponsors and Collaborators
CHU de Reims

Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT02867553     History of Changes
Other Study ID Numbers: PN09001
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents