Automated Total Marrow and Lymphoid Irradiation for Allogeneic Hematopoietic Cell Transplant
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 70 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether an automated system can safely deliver radiation to bone marrow and tissues of the immune system before a donor stem cell transplant. It is for adults with certain high-risk blood cancers, including people whose cancer returned after a prior donor transplant.
Intensive conditioning regimens used in allogeneic hematopoietic cell transplant (HCT) help to eliminate hematologic tumors and reduce the risk of relapse, but are also characterized by high toxicity. Total marrow and lymphoid irradiation (TMLI) is a specialized radiation technique that specifically targets marrow and lymphoid tissue to maximize antitumor efficacy while reducing off target toxicity. Despite these benefits, TMLI is technically challenging and time consuming. The radiation oncology team at Stanford has developed an automated TMLI platform to overcome these challenges. In this phase II trial, automation will be incorporated into a previously validated conditioning regimen of fludarabine/cyclophosphamide/TMLI HCT with post-transplant cyclophosphamide (PTCy) for graft-versus-host disease (GVHD) prophylaxis to confirm the feasibility and safety of automation in patients receiving allogeneic HCT for high-risk myeloid malignancies.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- For the 20 Gy radiation group: age 18–60, having your first donor stem cell transplant, and a transplant-related health problem score below 5.
- For the 20 Gy group: have acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), myeloproliferative neoplasm (MPN), or MDS/MPN overlap. These blood cancers must meet the study’s rules for high numbers of immature blood cells or certain gene changes.
- For the 12 Gy radiation group: age 18–70, with AML, MDS, MPN, or MDS/MPN overlap that returned after a prior donor stem cell transplant.
- Be able to care for yourself, with a daily activity score of at least 70%.
- Receive stem cells from a donor’s blood. You and the donor must have detailed tissue matching tests, and the donor must meet the study’s matching rules.
- Meet heart, lung, liver, and kidney test limits for your group, and not need extra oxygen.
- Agree to use birth control during treatment if sexually active and you or your partner could become pregnant.
- Freely agree to join and sign a consent form.
Who can't join
- Pregnant or breastfeeding. If you could become pregnant, you must have a negative pregnancy test before treatment.
- An active infection that is not treated. Infections that are controlled or cause no symptoms may be allowed while treatment continues.
- HIV with virus levels that can be detected in the blood.
- Active cancer in the brain or spinal cord.
- Graft-versus-host disease, when donor cells attack your body, needing whole-body treatment. This includes prednisone above 0.25 mg/kg or other whole-body medicines for this condition.
- Another serious medical or mental health condition that makes joining unsafe.
- Past radiation treatment that makes joining unsafe.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria for 20 Gy Arm (Cohort A) 1. Age, Performance Status, and Graft Criteria require all of the following bullet points: * Age 18 to 60 years (inclusive) * HCT Co-Morbidity score (HCT-CI) \< 5 (http://www.qxmd.com/calculate-online/hematology/hct-ci)(31) * Adequate performance status is defined as Karnofsky score ≥ 70% * Patients must be receiving an allogeneic peripheral blood stem cell graft * Patients and selected donor must be HLA typed at high resolution using DNA based typing at the following HLA-loci: HLA-A, -B, -C and DRB1. Donors may be an 8/8 matched sibling donor, 8/8 matched unrelated donor, haploidentical related donor, or 7/8 mismatched unrelated donor. 2. Eligible Diseases (Any one of the following) Acute Myeloid Leukemia (AML) Must have at least one of the following characteristics: * Blasts \>5% in the peripheral blood and/or bone marrow after \>2 prior lines of AML directed therapy, present during the trial screening window * Adverse plus risk by AlloHCT Refined ELN Criteria: defined as having complex cytogenetics, TP53 mutation, or MECOM rearrangement confirmed at any time point.(32) Myelodysplastic syndrome Must have at least one of the following characteristics at the time of conditioning: * Blasts \>10% in the peripheral blood and/or bone marrow after \>1 prior line of therapy. * TP53 mutation confirmed at any time point Myeloproliferative neoplasms (MPN) or MDS/MPN overlap. Must have at least one of the following characteristics: * Blasts \>10% in the peripheral blood and/or bone marrow during the trial screening window * TP53 mutation confirmed at any time point 3. Adequate organ function is defined as all of the following: Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \> 45% confirmed by MUGA or echocardiography Pulmonary: DLCO, FEV1, FVC \> 50% predicted, and absence of O2 requirements. Liver: Transaminases \< 3 x upper limit of normal (ULN) and total bilirubin ≤ 2 mg/dL except for patients with Gilbert's syndrome or hemolysis (as indicated by provider documentation). Renal: Creatinine \< 2.0 mg/dL (adults) and creatinine clearance \> 40 mL/min. 4. Must be FIRST allogeneic HCT 5. Sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control during study treatment. 6. Voluntary written consent Inclusion Criteria for 12 Gy Arm (Cohort B) 1. Age, Performance Status, and Graft Criteria require all of the following bullet points: Age 18 to 70 years (inclusive) Adequate performance status is defined as Karnofsky score ≥ 70% Patients must be receiving an allogeneic peripheral blood stem cell graft Patients and selected donor must be HLA typed at high resolution using DNA based typing at the following HLA-loci: HLA-A, -B, -C and DRB1. Donors may be an 8/8 matched sibling donor, 8/8 matched unrelated donor, haploidentical related donor, or 7/8 mismatched unrelated donor. 2. Eligible Diseases (Any of the following) Acute Myeloid Leukemia (AML) Myelodysplastic syndrome Myeloproliferative neoplasm MDS/MPN overlap 3. Must have relapse after prior allo HCT 4. Adequate organ function is defined as all of the following: Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \> 40% confirmed by MUGA or echocardiography Pulmonary: DLCO, FEV1, FVC \> 40% predicted, and absence of O2 requirements. Liver: Transaminases \< 3 x upper limit of normal (ULN) and total bilirubin ≤ 2 mg/dL except for patients with Gilbert's syndrome or hemolysis (as indicated by provider documentation). Renal: Creatinine \< 2.0 mg/dL (adults) and creatinine clearance \> 40 mL/min. Sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control during study treatment. 5. Voluntary written consent Exclusion Criteria: 1. Pregnant or breast feeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy. 2. Untreated active infection. Controlled or asymptomatic infections requiring continued antimicrobial therapy are permissible. 3. Active HIV infection, defined as HIV infection with detectable viral load 4. Active central nervous system malignancy 5. GVHD requiring systemic therapy including \> 0.25 mg/kg prednisone (or equivalent) or other systemic therapy for GVHD (e.g., tacrolimus, sirolimus, ruxolitinib, belumosodil, ibrutinib, axatilimab). 6. Any other medical or psychological condition that is deemed serious and unsafe for clinical trial participation. 7. Exposure to prior radiation that is deemed unsafe for clinical trial participation.
Study sites (1)
CA
- Stanford University · Palo Alto, CA 94304Hany Elmariah, MD · Study contact · 650-723-0822 · he3@stanford.eduHany Elmariah, MD · Principal investigatorMore trials in Palo Alto