2 Gy Total Body Irradiation As Part Of Conditioning Treatment For Patients With Acute Lymphoblastic Leukemia Undergoing CAR T Cell Therapy
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 and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
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
- Procedures mentioned: Blood draws, Infusions
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Secondary endpoints include changes from baseline in circulating inflammatory and immunosuppressive cytokine levels, as measured by multiplex secretome analyses using blood samples collected before TBI, after TBI, and on Day 7 and, optionally, Day 14 after CAR T-cell infusion."
- "To address this secondary objective, secondary endpoints include changes from baseline in circulating immune-cell phenotypes, T-cell subpopulations, TCR repertoire diversity, clonality, clonal expansion, and polyfunctional T-cell states, assessed using flow cytometry and TCR sequencing in blood samples collected before and after TBI, and on Day 7 and, optionally, Day 14 after CAR T-cell infusion."
- Compensation
- Not stated
- 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 compares whole-body radiation (2 Gy) before CAR T cell therapy with the usual treatment that lowers immune cell counts. CAR T cell therapy uses changed immune cells to fight cancer. The study is for adults planning CAR T cell therapy, but the title says acute lymphoblastic leukemia while the entry rules say acute lymphoblastic lymphoma.
The proposed research will compare the effects of TBI prior to CAR T cell infusion to the current standard of care using lymphodepletion.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older, have confirmed acute lymphoblastic lymphoma as listed in the entry rules, and plan to get CAR T cell therapy.
- Be able to care for yourself and be up and about for at least half the day.
- Meet blood count, liver, and kidney test guidelines: neutrophils (infection-fighting cells) at least 1,000/mcL; platelets (cells that help stop bleeding) at least 100,000/mcL; bilirubin and creatinine within normal limits; and liver enzymes no more than 3 times the normal limit.
- If you have long-term hepatitis B, a liver infection, the virus must be too low to detect, with treatment if needed.
- If you have had hepatitis C, another liver infection, it must be treated and cured, or you must be on treatment with no virus detected.
- Past or current cancer is allowed if it does not affect the study's safety or results. Past radiation, including whole-body radiation, is allowed.
- Use an approved birth control method. Men must use birth control before and during the study and for 6–12 months after CAR T cell therapy. Report any suspected pregnancy right away.
- Be able to understand the study and willing to sign a consent form.
Who can't join
- You are receiving another experimental drug.
- You need radiation to the brain and spinal cord for leukemia before CAR T cell therapy.
- You have another illness that is not under control.
- You have a mental health condition or life situation that would keep you from following study requirements.
- You are pregnant. Breastfeeding must stop because treatment may harm a nursing baby.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Patients must have a confirmed diagnosis of Acute Lymphoblastic Lymphoma and are planned to undergo CAT T cell therapy. The patient should not be planned to receive craniospinal irradiation prior to CAR T therapy; the latter group will be excluded from this study. Prior Radiation would not exclude patients from getting 2 Gy TBI, including prior TBI, in the event of a prior stem cell transplant. * Age ≥18 years. * ECOG performance status ≤2 (Karnofsky ≥60%,). * Patients must have adequate organ and marrow function as defined below: absolute neutrophil count ≥1,000/mcL Platelets ≥100,000/mcL total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN creatinine ≤ institutional ULN The above are guidelines that align with recommendations for any patient who is undergoing CAR T cell therapy. * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load. * Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. * Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. * Men treated or enrolled in this protocol must also agree to use adequate contraception before the study, for the duration of study participation, and 6- 12 months after completion of CAR T cell therapy administration. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients who are receiving any other investigational agents. * Patients who need craniospinal irradiation for CNS leukemia prior to CAR T cell therapy. * Patients with uncontrolled intercurrent illness (Indicate clearly what type or extent) * Patients with psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study because the conditioning regimen before CAR T, as well as radiation, will have both teratogenic and abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to the treatment of the mother, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study.
Study sites (1)
TX
- UT MD Anderson · Houston, TX 77030Bouthaina Dabaja, MD · Study contact · 713-563-2406 · bdabaja@mdanderson.orgBouthaina Dabaja, MD · Principal investigatorMore trials in Houston