Phase 2
N=22
Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-myeloablative Hematopoietic Cell Transplantation
Acute Myeloid Leukemia · Myelodysplastic Syndromes · Myeloproliferative Disorder · Chronic Lymphocytic Leukemia · B-cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT03734601 ↗Enrolled (actual)
22
Serious AEs
9.1%
Results posted
Jun 2021
Primary outcome: Primary: Full-dose Donor Chimerism (FDC) at Day 28 Following TLI/ATG/TBI Conditioning. — 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Total body irradiation (TBI) (Radiation); Anti-thymocyte globulin (ATG) (Drug); Tacrolimus (Drug); Mycophenolate mofetil (MMF) (Drug); Total lymphoid irradiation (TLI) (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Full-dose Donor Chimerism (FDC) at Day 28 Following TLI/ATG/TBI Conditioning. |
13 | — |
| SECONDARY Disease Progression |
7 | — |
| SECONDARY Overall Survival (OS) |
16 | — |
| SECONDARY Event-free Survival (EFS) at 1 Year |
16 | — |
| SECONDARY Non-relapse Mortality (NRM) |
2 | — |
| SECONDARY Graft vs Host Disease (GvHD) |
5; 8; 3 | — |
Summary
The purpose of this study is to evaluate whether addition of a low dose of total body irradiation (TBI) to a standard preparation for transplant [total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG)] conditioning will help to augment donor chimerism without reducing tolerability of this regimen or increasing the risk of graft-vs-host disease (GVHD)
Eligibility Criteria
INCLUSION CRITERIA
- Has a human leukocyte antigen (HLA)-matched or single allele mismatched adult sibling donor or unrelated donor.
- 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
- Uncontrolled bacterial, viral or fungal infection defined as currently taking medication and progression of clinical symptoms.
- 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) 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%
Data sourced from ClinicalTrials.gov (NCT03734601). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.