Table 3.

Recent active clinical trials of anti-CD45 mAbs in myeloid neoplasms.

Disease type and inclusion criteria	Drug or drug combination, other therapies	Outcome measures	(Estimated) enrollment	Clinical trials identifier	Trial status
AML R/R AML childhood MDS high-risk MDS JMML secondary AML, MDS	Fludarabine + TBI 131I-BC8 (131iodine-BC8, anti-CD45) aHSCT Cyclosporine, MMF	Primary: DLT and MTD of BC8 Secondary: TRM, ORR, DFS, chimerism, and GvHD	15	NCT00119366	Completed (2014)
Recurrent AML, ALL Secondary AML CMML High-risk MDS	Fludarabine + TBI 111In-BC8 (111indium-BC8) 90Y-BC8 (90yttrium-BC8) aHSCT Cyclosporine, MMF	Primary: MTD of BC8 Secondary: ORR, DOR, DFS, OS, GvHD, NRM, engraftment, and chimerism	17	NCT01300572	Active, not recruiting (completed early 2018)
R/R AML (CD45-positive) in patients ≥ 55 years	Fludarabine + TBI 131I-BC8 (131iodine-BC8, iomab-B) aHSCT Cyclosporine/tacrolimus, MMF	Primary: durable CR Secondary: OS	150	NCT02665065	Recruiting (estimated completion mid 2019)
AML, ALL in remission R/R AML, ALL secondary AML CMML high-risk MDS	Fludarabine + TBI 211At-BC8-B10 (211astatine-BC8) aHSCT Cyclosporine, sirolimus, MMF	Primary: MTD of BC8-B10 Secondary: ORR, DOR, DFS, OS, GvHD, NRM, engraftment, and chimerism	30	NCT03128034	Recruiting (estimated completion early 2026)

aHSCT, allogeneic hematopoietic stem cell transplantation; ALL, acute lymphoblastic leukemia; AML, acute myeloid leukemia; CMML, chronic myelomonocytic leukemia; CR, complete remission; DFS, disease-free survival; DLT, dose-limiting toxicity; DOR, duration of response; GvHD, graft-versus-host disease; JMML, juvenile myelomonocytic leukemia; mAb, monoclonal antibody; MDS, myelodysplastic syndrome; MMF, mycophenolate mofetil; MTD, maximum tolerated dose; NRM, non-relapse mortality; ORR, overall response rate; OS, overall survival; R/R, refractory/relapsed; TBI, total body irradiation; TRM, transplant-related mortality.

Data from http://ClinicalTrials.gov (Accessed: February 25, 2018).