Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-myeloablative Hematopoietic Cell Transplantation

• Status: Completed
• Trial end date: 2020-11-17
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Antilymphocyte Serum; Mycophenolic Acid; Tacrolimus

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) < 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%