NCT02543749

DC Vaccination in CML

Dendritic Cells as Autologous Vaccine in Patients With Chronic Myeloid Leukemia

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of this phase I/II trial is induction of anti leukemic T cell immunity in a clinical situation of "minimal residual disease". This might be a strategy to immunologically eradicate the residual leukemia cells. Patients to be included are chronic phase bcr/abl+ CML (chronic myeloid leukemia) patients in stable cytogenetic and/or molecular remission. These patients can be included if they have: 1. not achieved a CMR (complete molecular response) or 2. achieved bcr/abl \< 10% on qPCR (quantitative polymerase chain reaction) (=MCyR) (Major cytogenic Response), but less than a CCyR (complete cytogenic Response). Autologous DC (Dendritic cells), generated under GMP (Good manufacturing conditions) conditions, are used as a vaccine. These DC constitutively express all putative tumor antigens. In order to ensure sufficient presentation of distinct CML-related antigens, particularly in good responders to TKIs, DC are additionally pulsed with peptides from bcr/abl, WT-1 (Wilms Tumor Protein) and proteinase-3. Monitoring of T cell reactivity against these peptides can then serve as surrogate marker for anti leukemic immunity induced by the vaccine. Vaccination is performed with 10\^7 DC i.d. (intra dermal) in weeks 1, 3, 5, 8, 11, 14, 17, 20, 23 and 26. KLH (keyhole limpet hemocyanin) is used as an adjuvant for vaccine preparations in weeks 3, 5 and 8 (and 11).

Conditions

• Myeloid Leukemia, Chronic

Interventions

Type	Name	Description
BIOLOGICAL	DC vaccine	Autologous DC pulsed with leukemia-associated peptides+adjuvant

Timeline

• Start date: 2014-07-01
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2015-09-07
• Last updated: 2023-02-09

Locations

2 sites across 1 country: Germany