NL-OMON51961
Not yet recruiting
Phase 3
International cooperative prospective study for children and adolescents with standard risk ALK-positive anaplastic large cell lymphoma (ALCL) estimating the efficacy of Vinblastine. - ALCL-VB
German Pediatric Oncology Group (GPOH) gGmbH0 sites10 target enrollmentStarted: TBDLast updated:
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- German Pediatric Oncology Group (GPOH) gGmbH
- Enrollment
- 10
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 0 to 17 (—)
Inclusion Criteria
- •\* 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
Exclusion Criteria
- •\* 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)
Investigators
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