Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03939234 | Peptide Vaccination With PD-L1 and PD-L2 Peptides in Untreated Chronic Lymphatic Leukemia. | PHASE2 | COMPLETED | 19 | — | — | Apr 26, 2019 | Mar 15, 2021 | Feb 21, 2022 | 1 | Denmark |
Progressive disease (PD), stable disease (SD), partial response (PR), complete response (CR) calculated on basis of changes in circulating lymphocytes and lymphnode/spleen/liver size according to criteria from the international working group on CLL (IW-CLL).
| Arm | Type | Description |
|---|---|---|
| Vaccination | EXPERIMENTAL | Untreated CLL patients with unmutated IgHV gene with a cut of at maximum of 2 % mutations. According to guidelines from the European Research Initiative on CLL (ERIC). |
| Name | Type | Description |
|---|---|---|
| PD-L1, PD-L2 peptides with Montanide ISA51 | COMBINATION_PRODUCT | PD-L1: 19 amino acid sequence from the PD-L1 protein; PD-L2: 21 amino acid sequence from the PD-L2 protein; The peptides are dissolved in dimethyl sulphoxide (DMSO) and mixed with Montanide. |
Inclusion Criteria: * CLL according to national guidelines (Lymphoma.dk). * Unmutated IGHV gene according to ERIC recommendations.(25) * No prior CLL directed treatment * Age ≥ 18 * Eastern cooperative oncology group (ECOG) performance status of 0 or 1 * No life-threatening conditions * Adequate bo...