DRKS00023541
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
Gesellschaft für pädiatrische Hämatologie und Onkologie (GPOH) gGmbH0 sites106 target enrollmentStarted: March 9, 2021Last updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Gesellschaft für pädiatrische Hämatologie und Onkologie (GPOH) gGmbH
- Enrollment
- 106
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- N/a: Single Arm Study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 0 Years to 18 Years (—)
- Sex
- All
Inclusion Criteria
- •Stratification into the standard risk group (SR) by screening:
- •o Newly diagnosed ALK\-positive ALCL
- •o Stage I not completely resected, or stage II or stage III
- •o 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) before start of the protocol treatment
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
- •o the obligatory initial intrathecal triple therapy with Methotrexate, Cytarabine and Prednisolone (or Hydrocortisone respectively)
- •o a possible clinically indicated pre\-phase including up to 5 days of steroids combined with up to 3 doses of Vinblastine (and up to 2 doses of Cyclophosphamide)
- •Pregnancy or lactation period
- •Contraindications for the treatment with Vinblastine:
- •o hypersensitivity against VBL or other vinca\-alkaloids
- •o leukopenia, other than in the context of the ALCL
- •o severe uncontrolled infection
Investigators
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