Vaccine Therapy in Treating Patients with Acute Myeloid Leukemia following Chemotherapy-Induced Remission

Active:	No
Cancer Type:	Leukemia	NCT ID:	NCT03059485
Trial Phases:	Phase II	Protocol IDs:	16-593 (primary) NCI-2017-01191
Eligibility:	55 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Dana-Farber Harvard Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT03059485

Summary

This randomized phase II trial studies how well vaccine therapy works in treating patients with acute myeloid leukemia following chemotherapy-induced remission. Vaccines made from a person's tumor cells may help the body build an effective immune response to kill tumor cells that express acute myeloid antigen.

Objectives

PRIMARY OBJECTIVE:
I. To assess the impact of therapy on 2-year progression free survival. (Clinical)

SECONDARY OBJECTIVES:
I. To assess the impact of therapy on overall survival. (Clinical)
II. To assess the toxicity associated with treating acute myeloid leukemia (AML) patients who are in remission with dendritic cell (DC)/AML fusion cells. (Clinical)
III. To assess the effect of vaccination with DC/AML fusions on the expansion of leukemia specific T cells. (Correlative)
IV. To determine immunologic response to neoantigens arising from patient specific mutational events. (Correlative)

OUTLINE: Patients who achieve complete remission after 1-2 courses of induction chemotherapy or up to 4 cycles of hypomethylating agents (alone or in conjunction with venetoclax) as standard of care, are randomized to 1 of 2 arms.

ARM A: Beginning 4-8 weeks after completing standard of care post-remission chemotherapy, patients receive allogeneic AML antigen-expressing dendritic cell vaccine subcutaneously (SC) and sargramostim SC in weeks 1, 5, and 9.

ARM C: Beginning 4-8 weeks after completing standard of care post-remission chemotherapy, patients undergo observation.

After completion of study treatment, patients are followed up monthly for 6 months, at 12 months, and then every 6 months for 5 years.

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.