IPA Targeted Adoptive Immunotherapy vs Adult Haplo-identical Cell Infusion During Induction of High Risk Leukemia

Summary

The purpose of this study is to determine the overall safety of adoptive immunotherapy when given after chemotherapy for AML/MDS. Adoptive immunotherapy means using an infusion of cells from a donor to help fight cancer. The donor cells will be either from the umbilical cord blood (UCB) of a newborn baby or they will be cells collected from a relative (haplo-identical cells). The 2 cohorts that were discussed - adoptive immunotherapy with either UCB or haplo-identical stem cells - will be analyzed separately. Preliminary data from other centers has suggested that adoptive immunotherapy with cells from a relative is an effective approach that may improve remission rates and survival in AML and MDS, because they exert anti-cancer effects of their own (so called graft vs leukemia effects) and possibly because they hasten recovery of cell counts from chemotherapy. The Investigators are interested in confirming these data, but also in testing umbilical cord blood cells for the same purpose. Preliminary data indicate that umbilical cord blood cells may have more powerful graft vs leukemia effects and cause fewer side-effects.

Timeline

Start

2015-09-10

Primary completion

2022-06-24

Completion

2022-06-24

Outcome

Outcome not reported

Stopped (Enrollment): “Slow accrual and change in direction of cord blood program”

Publications

• Chaekal OK, Scaradavou A, Masson Frenet E, Albano MS, Cushing M, Desai P, Dobrila L, Gergis U, Guarneri D, Hsu JM, Lee S, Mayer SA, Phillips AA, Orfali N, Ritchie EK, Roboz GJ, Romeo C, Samuel MS, Shore T, van Besien K. Adoptive immunotherapy with CB following chemotherapy for patients with refractory myeloid malignancy: chimerism and response. Blood Adv. 2020 Oct 27;4(20):5146-5156. doi: 10.1182/bloodadvances.2020002805.

Drugs

Indications