Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-myeloablative Hematopoietic Cell Transplantation
NCT ID: NCT03734601
Last Updated: 2023-12-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
22 participants
INTERVENTIONAL
2018-11-05
2020-11-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
• Determine the proportion of patients with full donor T-cell chimerism at Day 28 following hematopoietic cell transplantation.
Secondary Objectives:
* Determine the risk of disease progression, overall and event free survival, and non-relapse mortality, following treatment with TLI; ATG; and TBI.
* Determine the incidence of acute and chronic GVHD following treatment with TLI; ATG; and TBI.
Exploratory Objectives:
• Determine the changes in frequency of hematopoietic stem, progenitor, and mature cell subsets and the changes in cytokine milieu and cellular architecture in the bone marrow of patients receiving TLI compared to TLI+TBI.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TBI+TLI
TBI, single exposure on Day -1, 80 centigray (cGy) in addition to total lymphoid irradiation (TLI, 120 cGy/day for 9 days, weekends excluded) and anti-thymocyte globulin (ATG) 1.5 mg/kg (conditioning regimen)
Total body irradiation (TBI)
Administer Total body irradiation (TBI) 80 cGy on Day 1 of standard TLI ATG conditioning
Anti-thymocyte globulin (ATG)
Given intravenous (IV), Dose 1.5 mg/kg x 5 days
Tacrolimus
Oral, Dose 0.05 mg/kg twice daily, can be given intravenous (IV)
Mycophenolate mofetil (MMF)
Given Oral, 15 mg/k every 2 hours for peripheral blood stem cells (PBSC) from matched related donors; 15 mg/kg every 8 hours for PBSC from unrelated donors (URDs) or mismatched related donors.
Total lymphoid irradiation (TLI)
9 x 120 cGy over 11 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Total body irradiation (TBI)
Administer Total body irradiation (TBI) 80 cGy on Day 1 of standard TLI ATG conditioning
Anti-thymocyte globulin (ATG)
Given intravenous (IV), Dose 1.5 mg/kg x 5 days
Tacrolimus
Oral, Dose 0.05 mg/kg twice daily, can be given intravenous (IV)
Mycophenolate mofetil (MMF)
Given Oral, 15 mg/k every 2 hours for peripheral blood stem cells (PBSC) from matched related donors; 15 mg/kg every 8 hours for PBSC from unrelated donors (URDs) or mismatched related donors.
Total lymphoid irradiation (TLI)
9 x 120 cGy over 11 days
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Acute myeloid leukemia (AML); myelodysplastic syndrome (MDS); myeloproliferative disease syndrome (MPD)\]; chronic lymphocytic leukemia (CLL); B- or T-cell non Hodgkin lymphoma (NHL); Hodgkin lymphoma (HL); or chronic myelomonocytic leukemia (CMML), suitable for treatment with allogeneic transplant after TLI and ATG reduced intensity conditioning.
* Considered at high-risk for regimen-related toxicity from fully-ablative transplant conditioning (therefore reduced-intensity conditioning is recommended).
* Ability to understand and the willingness to sign a written informed consent document. Patients must have signed informed consent to participate in the trial.
Exclusion Criteria
* Progressive hemato lymphoid malignancy despite conventional therapy.
* Chronic myelogenous leukemia (CML).
* Active CNS involvement of the underlying malignancy.
* HIV positive
* Pregnant or lactating
* Prior malignancy (EXCEPTION: diagnosed \> 5 years ago without evidence of disease, OR treated ≤ 5 years ago but have a greater than 50% chance of life expectancy of ≥ 5 years for that malignancy).
* Have a psychiatric disorder(s) or psychosocial circumstance(s) which in the opinion of the primary physician would place the patient at an unacceptable risk from transplant.
* Left ventricular ejection fraction (LEVF) \< 30%, or uncontrolled cardiac failure
* Diffusing capacity of lung for carbon monoxide (DLCO) \< 40% predicted
* Total bilirubin \> 3 mg/dL
* Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) \> 4 x upper limit of normal (ULN)
* Creatinine \> 2 mg/dL and an estimated creatinine clearance \< 40 mL/min
* Poorly-controlled hypertension despite multiple antihypertensive medications
* Karnofsky Performance Status (KPS) \< 60%
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Stanford University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Robert Lowsky
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert Lowsky, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stanford University School of Medicine
Stanford, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BMT330
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-47407
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-47407
Identifier Type: -
Identifier Source: org_study_id