International cooperative prospective study for children and adolescents with standard risk ALK-positive anaplastic large cell lymphoma (ALCL) estimating the efficacy of Vinblastine.
- Conditions
- Anaplastic large-cell lymphoma (ALCL)lymphnode cancer10025322
- Registration Number
- NL-OMON51961
- Lead Sponsor
- German Pediatric Oncology Group (GPOH) gGmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
* Stratification into the standard risk group (SR):
-Newly diagnosed ALK-positive ALCL
-Stage I not completely resected, or stage II or stage III
-MDD negative
* Age < 18 years
* Informed consent of the parents/legal guardians (and assent of the competent
child) for study participation and data collection, storage and handling given
before study entry
* Participation in national / study group's reference pathology
* Follow-up for at least 3 years after enrolment is expected
* Application of a highly effective contraceptive method (Pearl index <1) in
sexually active patients
* Application of one intrathecal triple therapy with Methotrexate, Cytarabine
and Prednisolone (or Hydrocortisone respectively)
* Progressive disease during a possible clinically indicated pre-phase
treatment before inclusion in the study
* Steroids for more than 2 days or chemotherapy pre-treatment before taking the
screening sample for MDD
* Chemotherapy pre-treatment before start of the study treatment except for
-the obligatory initial intrathecal triple therapy with Methotrexate,
Cytarabine and Prednisolone (or Hydrocortisone respectively)
-a possible clinically indicated pre-phase including up to 5 days of steroids
combined with up to 3 doses of Vinblastine (or up to 2 doses of
Cyclophosphamide)
* Pregnancy or lactation period
* Contraindications for the treatment with Vinblastine:
-hypersensitivity against VBL or other vinca-alkaloids
-leukopenia, other than in the context of the ALCL
-severe uncontrolled infection
* Other medical, psychiatric, familial or social condition prohibiting
treatment according to the protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Probability of event-free-survival (pEFS) at 3 years, with EFS defined as the<br /><br>time of diagnosis to the first event (progressive disease, nonresponse,<br /><br>secondary malignancy or death due to any cause) or last follow-up.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Overall survival<br /><br>- Treatment related mortality<br /><br>- Time from diagnosis to progressive disease /event<br /><br>- Toxicity<br /><br>- Response</p><br>