A randomized, phase II trial of adjuvant immunotherapy with durable TKI-free survival in patients with chronic phase CML.

ABSTRACT:

Purpose

Chronic myeloid leukemia (CP-CML) patients can achieve undetectable minimal residual disease (UMRD) and discontinue tyrosine kinase inhibitors (TKIs). Cellular immunity plays an important role in CML disease control. We conducted a randomized, non-blinded phase II trial of adjuvant immunotherapy with TKIs to facilitate TKI discontinuation.

Methods

TKI-treated patients with CP-CML were randomized to receive the K562/GM-CSF vaccine (vaccine) OR Interferon-α + Sargramostim (IFN). If UMRD was achieved, then all treatment was stopped. Patients who did not achieve UMRD within one year, had a molecular relapse, or discontinued therapy for toxicity could crossover.

Results

Thirty-four patients were randomized to IFN (n = 18) or vaccine (n = 16), and 21 patients crosse

SUBMITTER: Webster JA 

PROVIDER: S-EPMC8643330 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature