CH14.18 1021 Antibody and IL2 After Haplo SCT in Children With Relapsed Neuroblastoma

Summary

A six courses regimen consisting of a 8 hour infusion (ch14.18/CHOmAb 20 mg/m²) for five consecutive days will be administered every 4 weeks, starting 60-180 days after previous haploidentical stem cell transplantation. Interleukin 2 will be added to cycles 4-6 at days 6,8,10 (1 x 106 IU/m²/d s.c.) Participants will be premedicated with an intravenous antihistamine and ranitidine within approximately 30 minutes prior and during the infusion of the study agent Pain as an anticipated side effect is managed by a standard pain prophylaxis with Morphium hydrochloride Disease status will be evaluated after 3 and 6 courses and after 1 year

Timeline

Start

2010-08

Primary completion

2018-11

Completion

2022-12

Publications

• Flaadt T, Ladenstein RL, Ebinger M, Lode HN, Arnardottir HB, Poetschger U, Schwinger W, Meisel R, Schuster FR, Doring M, Ambros PF, Queudeville M, Fuchs J, Warmann SW, Schafer J, Seitz C, Schlegel P, Brecht IB, Holzer U, Feuchtinger T, Simon T, Schulte JH, Eggert A, Teltschik HM, Illhardt T, Handgretinger R, Lang P. Anti-GD2 Antibody Dinutuximab Beta and Low-Dose Interleukin 2 After Haploidentical Stem-Cell Transplantation in Patients With Relapsed Neuroblastoma: A Multicenter, Phase I/II Trial. J Clin Oncol. 2023 Jun 10;41(17):3135-3148. doi: 10.1200/JCO.22.01630. Epub 2023 Feb 28.
• Seitz CM, Flaadt T, Mezger M, Lang AM, Michaelis S, Katz M, Syring D, Joechner A, Rabsteyn A, Siebert N, Troschke-Meurer S, Zumpe M, Lode HN, Yang SF, Atar D, Mast AS, Scheuermann S, Heubach F, Handgretinger R, Lang P, Schlegel P. Immunomonitoring of Stage IV Relapsed Neuroblastoma Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplantation and Subsequent GD2 (ch14.18/CHO) Antibody Treatment. Front Immunol. 2021 Jul 22;12:690467. doi: 10.3389/fimmu.2021.690467. eCollection 2021.

Drugs

Indications