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

A Phase II Single-Arm Study of Total Body Irradiation With Linac Based Volumetric Modulated Arc Therapy (VMAT) and Image Guided Radiation Therapy (IGRT)

NCT04509765•NYU Langone Health

View on ClinicalTrials.gov

Summary

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

Detailed Description

Total Body Irradiation (TBI) continues to play an important role in myeloablative and non-myeloablative conditioning regimens for Allogeneic Stem Cell Transplant (ASCT). When TBI is used as part of a myeloablative regimen, it is combined with chemotherapy to eradicate malignant cells, as well as to immunosuppress the host to prevent rejection of donor hematopoietic progenitor cells (HPC). This study is a single-institution study to assess the safety of linac based VMAT TBI for myeablative sreatment in hematologic malignancies.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18
•2. 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.
•a. Conditioning regimens outlined per BMT SOP: CLNTX007: Selection of Conditioning Regimens for Blood and Marrow Transplantation - ADULTS.

Exclusion Criteria

•1. BMT program will initiate referral, utilizing Form: 170102, Radiation Oncology Consultation.
•2. 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.
•i. BMT SOP's include baseline pulmonary function tests (PFTs). Patient with decreased FVC, FEV1 and or DLCO (adjusted for hemoglobin) or pulmonary history will have pulmonary consult, at the discretion of the BMT physician prior to undergoing myeloablative radiation.
•ii. Medical history and physical by BMT provider.
•iii. The following laboratory tests (additional testing may be required for positive results):
•ABO group and Rh type
•Red Blood Cell Antibody Screen.
•HLA typing and confirmatory typing
•HLA antibody screen, class I and II, performed within 30 days of transplant.
•Complete blood count (CBC) with differential.
+9 more criteria

Locations (1)

NYU Langone Health

New York, New York, United States

Key Dates

Start Date

September 22, 2020

Primary Completion Date

February 11, 2025

Completion Date

February 11, 2025

Last Updated

April 9, 2025

Enrollment

ACTUAL participants

Conditions

Hematologic Malignancy

Interventions

Linac Based VMAT TBI

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

CD45RA-depleted CD19-CAR T Cell Consolidation After TCRαβ+/CD19 B Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed/Refractory CD19+ ALL and Lymphoma

ONC-MM-2407: The Effect of Virtual Reality Headsets on Pain and Anxiety in the Peri and Post Bone Marrow Biopsy Period

TCRαβ-depleted Progenitor Cell Graft With Early Memory T-cell DLI, Plus Selected Use of Blinatumomab, in naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies

Study Evaluating the Safety and the Efficacy of Human T Lymphoid Progenitor (HTLP) Injection to Accelerate Immune Reconstitution After Umbilical Cord Blood (UCB) Transplantation in Adult Patients With Hematologic Malignancies (HTLP-ONCO)

Telerehabilitation in Hemato-oncological Survivors