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Clinical Trial
. 2024 Sep 24;8(18):4812-4822.
doi: 10.1182/bloodadvances.2023012497.

Yttrium-90 anti-CD25 BEAM conditioning for autologous hematopoietic cell transplantation in Peripheral T-cell lymphoma

Affiliations
Clinical Trial

Yttrium-90 anti-CD25 BEAM conditioning for autologous hematopoietic cell transplantation in Peripheral T-cell lymphoma

Jasmine Zain et al. Blood Adv. .

Abstract

Peripheral T-cell lymphomas (PTCLs) have a poor prognosis with current treatments. High-dose chemotherapy followed by autologous hematopoietic cell transplant (AHCT) is used as a consolidation strategy after achieving clinical remission with first-line therapy, as well as in chemotherapy-sensitive relapse if allogeneic transplant is not an option. CD25 is a targetable protein often highly expressed in PTCLs. In this phase 1 clinical trial, we tested the addition of β-emitting 90yttrium (90Y)-labeled chimeric anti-CD25 basiliximab (aTac) to BEAM (carmustine, etoposide, cytarabine, and melphalan) as conditioning for AHCT for patients with PTCL. Twenty-three AHCT-eligible patients were enrolled, and 20 received therapeutic 90Y-aTac-BEAM AHCT. Radiation doses of 0.4, 0.5, and 0.6 mCi/kg were tested. With no observed dose-limiting toxicities, 0.6 mCi/kg was deemed the recommended phase 2 dose. The most prevalent adverse effect, grade 2 mucositis, was experienced by 80% of patients. As of this report, 6 (30%) of the treated patients had died, 5 due to progressive disease and 1 due to multiple organ failure (median time of death, 17 months [range, 9-21]) after AHCT. Median follow-up was 24 months (range, 9-26) overall and 24 months (range, 13-26) for surviving patients. For patients who received therapeutic 90Y-aTac-BEAM AHCT, the 2-year progression-free and overall survival were 59% (95% confidence interval [CI], 34-77) and 68% (95% CI, 42-84), respectively. 90Y-aTac-BEAM appears to be safe as an AHCT conditioning regimen for PTCL, with no increased toxicity over the toxicities historically seen with BEAM alone in this patient population. This trial was registered at www.ClinicalTrials.gov as #NCT02342782.

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Conflict of interest statement

Conflict-of-interest disclosure: J.Z. is a consultant for Kyowa Kirin, Seattle Genetics, Verastem, Daiichi Sankyo, and Mundi Pharma; serves of the speakers bureau of Seattle Genetics, SecureBio, Daiichi Sankyo, and AbbVie; and reports research support from Seattle Genetics, SecureBio, Daiichi Sankyo, and AbbVie. J.W. reports grant support from RefleXion Inc, Varian Inc, Accuray Inc, Telix Inc, and Blue Earth Diagnostics, Inc. A.F.H. reports research funding from Bristol Myers Squibb, Merck, Genentech, Inc, F. Hoffmann-La Roche Ltd, Gilead Sciences, Seattle Genetics, AstraZeneca, and ADC Therapeutics; and reports consultancy with Bristol Myers Squibb, Merck, Genentech, Inc, F. Hoffmann-La Roche Ltd, Kite Pharma/Gilead, Seattle Genetics, Karyopharm, Takeda, Tubulis, and AstraZeneca. S.D. reports research funding from Bayer. A.M.W. reports consultancy and board membership with ImaginAb; and reports consultancy with AstraZeneca, and Novartis Institute for Biomedical Research. The remaining authors declare no competing financial interests.

Figures

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Graphical abstract
Figure 1.
Figure 1.
Treatment schema and CONSORT diagram.
Figure 2.
Figure 2.
Kaplan-Meier estimates of survival in all treated patients. (A) Kaplan-Meier plots of OS and PFS. (B) Tabulation of OS, PFS relapse, and nonrelapse mortality at the indicated time points after transplant.
Figure 3.
Figure 3.
Biodistribution of 111In-basiliximab at 72 hours (left) and 18F-FDG-PET (right). There is positive uptake in right external iliac/obturator and right inguinal areas as seen on the basiliximab scan but there was no 18FDG uptake in the area.

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