Extrait

Primary objective is to evaluate the safety, clinical toxicity and in vivo immunological effects of a patient-individualized peptide vaccination in pediatric patients with acute lymphoblastic leukemia who experienced ≥ 2nd relapse or ≥ 1st relapse after previous stem cell transplantation. Primary endpoint is "success of treatment" defined as a patient showing a vaccination-induced T-cell response without unacceptable toxicity and acute GvHD  Grade III or extensive chronic GvHD until day 120 (after 10 vaccinations). Therefore, a composite variable is used as primary endpoint: Treatment success is defined as a patient without 1. unacceptable toxicities (grade 4 according to NCI-CTC) 2. acute GvHD ≥ Grade III or extensive chronic GvHD and in whom 3. a vaccine-specific response of CD4+ and/or CD8+ T cells could be induced The primary endpoint will be measured at day 120 after 10 vaccinations were administered.

Critère d'inclusion

• Relapsed acute lymphatic leukemia,Rückfall einer akuten lymphatischen Leukämie

Liens

• ictrp
• euctr