CompletedNot Applicable

A Phase II Single-arm Study of Total Body Irradiation With Linac Based VMAT and IGRT

United States36 participantsStarted 2020-09-22

Plain-language summary

Single institution study of safety of linac based VMAT TBI for myeloablative treatment in hematologic malignancies.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥ 18
✓. Patients undergoing related, unrelated (including cord blood) hematopoietic progenitor cell (HPC) transplant, in which the protocol requires \>12 Gray of TBI, as part of the conditioning regimen.

✕. BMT program will initiate referral, utilizing Form: 170102, Radiation Oncology Consultation.
✕. Patients undergo pre-transplant testing, as defined in BMT SOPs:CLNAL002: Related (MRD, Haplo) Allogeneic Recipient Evaluation and Management or CLNAL011: Unrelated (MUD, MMUD, CBU) Allogeneic Recipient Evaluation and Management, per below.
✕. Patient receiving less than 1200 cGy of TBI
✕. Previous history of thoracic radiation therapy including previous TBI
✕. All premenopausal women will require a urine qualitative pregnancy test to exclude pregnancy. Pregnant women will be excluded from the study.
✕. Prisoners
✕. Patient not meeting transplant criteria per BMT physician.

Proportion of Patients Who Achieve Excellent Coverage While Sparing the Lung

Timeframe: Up to 1 year post-transplant

NCT IDNCT04509765

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-11

Results submitted2026-04-13