Acute Lymphoblastic LeukemiaNCT07856758
2 Gy Total Body Irradiation As Part Of Conditioning Treatment For Patients With Acute Lymphoblastic Leukemia Undergoing CAR T Cell Therapy
A study testing CAR T cell therapy in people with Acute Lymphoblastic Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The proposed research will compare the effects of TBI prior to CAR T cell infusion to the current standard of care using lymphodepletion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- CAR T cell therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2027to 1 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UT MD Anderson
Houston, Texas, 77030
Bouthaina Dabaja, MD, 713-563-2406, bdabaja@mdanderson.org
Bouthaina Dabaja, MD
About this study
The proposed research will compare the effects of TBI prior to CAR T cell infusion to the current standard of care using lymphodepletion.
Read the detailed description
Primary Objective:
To understand how 2 Gy TBI administered before CAR T cell infusion changes the immune system compared to a control group with no TBI, with the potential to improve the infused cell engraftment, efficacy, and sustainability. The primary endpoint is CAR T-cell level. Compare both groups by looking at the CAR T cell levels at standard of care time points 1, 4, 8, 11, 14, 21, and 28, and then every 3 months for a total of a year
Secondary Objectives:
Preliminarily estimate the effects of TBI on circulating inflammatory and immunosuppressive cytokines in the blood. The working hypothesis is that TBI increases circulating inflammatory cytokine levels and reduces immunosuppressive cytokine levels. 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.
Characterize changes in circulating immune-cell phenotypes in blood before and after TBI, days 7 and, optionally, day 14 after CAR T. The working hypothesis is that TBI affects circulating T-cell subpopulations and functional phenotypes to facilitate CAR T-cell engraftment. 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.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- CAR T cell therapy
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR T cell therapyDrug
CAR T cell therapy will be administered as per the institutional guidelines and as per our standard of care
| Study group | Role | What they receive |
|---|---|---|
| No TBI: No TBI Before CAR T Cell Infusion | Experimental | The Isoplexis Proteomics Platform will be used to interrogate up to 30 protein participants from single cells and bulk serum samples. Receives: Drug: CAR T cell therapy |
| TBI: TBI 2 Gy Before CAR T Cell Infusion | Experimental | The Isoplexis Proteomics Platform will be used to interrogate up to 30 protein participants from single cells and bulk serum samples. Receives: Drug: CAR T cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Mar 2027 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bouthaina Dabaja, MD, Principal investigator, UT MD Anderson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856758
- Sponsor's protocol ID
- 2026-0930
- Other IDs
- NCI-2026-07295
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2 Gy Total Body Irradiation As Part Of Conditioning Treatment For Patients With Acute Lymphoblastic Leukemia Undergoing CAR T Cell Therapy
- ClinicalTrials.gov ID
- NCT07856758
- Acronym / sponsor ID
- 2026-0930
- Conditions
- Acute Lymphoblastic Leukemia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed research will compare the effects of TBI prior to CAR T cell infusion to the current standard of care using lymphodepletion.
Detailed description
Primary Objective:
To understand how 2 Gy TBI administered before CAR T cell infusion changes the immune system compared to a control group with no TBI, with the potential to improve the infused cell engraftment, efficacy, and sustainability. The primary endpoint is CAR T-cell level. Compare both groups by looking at the CAR T cell levels at standard of care time points 1, 4, 8, 11, 14, 21, and 28, and then every 3 months for a total of a year
Secondary Objectives:
Preliminarily estimate the effects of TBI on circulating inflammatory and immunosuppressive cytokines in the blood. The working hypothesis is that TBI increases circulating inflammatory cytokine levels and reduces immunosuppressive cytokine levels. 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.
Characterize changes in circulating immune-cell phenotypes in blood before and after TBI, days 7 and, optionally, day 14 after CAR T. The working hypothesis is that TBI affects circulating T-cell subpopulations and functional phenotypes to facilitate CAR T-cell engraftment. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No TBI: No TBI Before CAR T Cell Infusion | Experimental | Drug: CAR T cell therapyThe Isoplexis Proteomics Platform will be used to interrogate up to 30 protein participants from single cells and bulk serum samples. |
| TBI: TBI 2 Gy Before CAR T Cell Infusion | Experimental | Drug: CAR T cell therapyThe Isoplexis Proteomics Platform will be used to interrogate up to 30 protein participants from single cells and bulk serum samples. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAR T cell therapyCAR T cell therapy will be administered as per the institutional guidelines and as per our standard of care | Drug | No TBI: No TBI Before CAR T Cell Infusion, TBI: TBI 2 Gy Before CAR T Cell Infusion |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- UT MD Anderson WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bouthaina Dabaja, MD principal investigator
UT MD Anderson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAR T cell therapy in people with Acute Lymphoblastic Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bouthaina Dabaja, MD ((713) 563-2406, bdabaja@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.