Treatment protocol for relapsed anaplastic large cell lymphoma of childhood and adolescence - Relapsed ALC
- Conditions
- Anaplastic large cell lymphoma
- Registration Number
- EUCTR2005-003321-57-GB
- Lead Sponsor
- HL NHL Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 96
Patients meeting the following criteria are eligible to be enrolled in the study:
·Progression or relapse of anaplastic large cell lymphoma diagnosed either by histomorphological or cytomorphological characterisation
·slides of relapsed lymphoma available for national/international pathological and/or cytomorphology review
·age < 22 years
·signed informed consent from patient/guardians for participation in the study ALCL-Relapse
·no evidence of pregnancy or lactation; assured contraception
·no participation in another clinical study during recruitment on the ALCL-Relapse study
·
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Patients listed below are not eligible for the study:
·2nd or subsequent relapse of ALCL
·significant pre-treatment for 1st relapse (previous chemotherapy or radiotherapy within two months prior to starting the ALCL-Relapse protocol)
·inadequate hepatic, renal and cardiac function
·HIV infection or AIDS, severe immunodeficiency
·previous organ transplantation
·previous malignancy prior to anaplastic large cell lymphoma
·pre-existing disease prohibiting chemotherapy as per instructions of the protocol
·clinical condition prohibiting the conditioning regimen as per instruction of the protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method