Clinical trial · Interventional
Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-myeloablative Hematopoietic Cell Transplantation
Very Low-dose Total Body Irradiation in Combination With Total Lymphoid Irradiation and Anti-Thymocyte Globulin to Improve Donor Engraftment in Patients Undergoing Non-Myeloablative Hematopoietic Cell Transplantation
NCT03734601CI-TRIAL-00072166completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| B-cell Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Chronic Myelomonocytic Leukemia | Chronic Myelomonocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Myeloproliferative Disorder | Myeloproliferative Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-thymocyte globulin (ATG) | Drug | — | UNRESOLVED |
| Mycophenolate mofetil (MMF) | Drug | — | UNRESOLVED |
| Tacrolimus | Drug | — | UNRESOLVED |
| Total body irradiation (TBI) | Radiation | — | UNRESOLVED |
| Total lymphoid irradiation (TLI) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TBI+TLI
- description
- 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)
- interventionNames
- Radiation: Total body irradiation (TBI)
- Drug: Anti-thymocyte globulin (ATG)
- Drug: Tacrolimus
- Drug: Mycophenolate mofetil (MMF)
- Radiation: Total lymphoid irradiation (TLI)
Primary outcomes (1)
- measure
- Full-dose Donor Chimerism (FDC) at Day 28 Following TLI/ATG/TBI Conditioning.
- timeFrame
- Day 28
- description
- Subsequent to TLI/ATG/TBI conditioning, the proportion of participants with full dose donor chimerism (FDC) will be determined by Day 28. FDC is defined as achieving ≥ 95% donor type in the CD3+ lineage within 28 days of donor cell infusion, as assessed by short tandem repeat (STR) testing. The outcome will be expressed as the number of participants that achieve FDC by Day 28, a number without dispersion.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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) \< 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%
References
Publications (0)
Data not yet available
No reference posted for this study.