BridgeMD
International study for children and adolescents with standard risk ALK-positive anaplastic large cell lymphoma (ALCL) estimating the efficacy of Vinblastine
EU CTIS ID: 2022-501454-11-00
What this study is testing
To show that it is possible to cure at least 75% of patients belonging to the SR group with Vinblastine-monotherapy for 24 months.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Stratification into the standard risk group (SR) by screening: 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
You likely can't join if
- 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 (and 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
See the full eligibility criteria
- Stratification into the standard risk group (SR) by screening: 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) before start of the protocol treatment
- 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 (and 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.