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drugset / Trial / NCT02105116

AML Therapy With Irradiated Allogeneic Cells

NCT02105116 ↗

Terminated 6 enrolled Rutgers, The State University of New Jersey National Cancer Institute (NCI) · collabRutgers Cancer Institute of New Jersey · collab
NaSingle-groupOpen-labelTreatment

Summary

This pilot clinical trial studies if cells donated by a close genetic relative can help maintain acute myeloid leukemia (AML) complete remission (CR). Eligible patients will receive a standard induction chemotherapy. If a complete remission results they will receive irradiated allogeneic cells from a HLA haploidentical relative. Only patients who obtain a CR after the standard induction chemotherapy are eligible for the experimental therapy (irradiated haploidentical cells).

Timeline

Start
2014-02
Primary completion
2015-12-16
Completion
2015-12-16

Outcome

Outcome not reported

Stopped: “No patients were eligible to receive the experimental component of the protocol therapy.”

Drugs

EvaluationDrugModalityDoseRoute
Subject donor lymphocytes Cell therapy 3e+08 cells/kg —
Background Cytarabine Small molecule — Intravenous
Background Fludarabine Small molecule — Intravenous
Background G-CSF Unknown 5 ug/kg Intravenous

Indications

acute erythroid leukemia acute megakaryoblastic leukemia in adult acute myeloblastic leukemia with maturation acute myeloblastic leukemia without maturation acute myeloid leukemia with 11q23 abnormalities acute myeloid leukemia with abnormal bone marrow eosinophils inv(16)(p13q22) or t(16;16)(p13;q22) acute myeloid leukemia with minimal differentiation acute myeloid leukemia with t(8;21)(q22;q22) translocation acute myeloid leukemia, del(5q31-q32) acute myeloid leukemia, t(16;16)(p13.1;q22) acute myelomonocytic leukemia M4 adult acute monocytic leukemia