2 Gy Total Body Irradiation As Part Of Conditioning Treatment For Patients With Acute Lymphoblastic Leukemia Undergoing CAR T Cell Therapy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

The proposed research will compare the effects of TBI prior to CAR T cell infusion to the current standard of care using lymphodepletion.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • CAR T cell therapy

    Drug

    CAR T cell therapy will be administered as per the institutional guidelines and as per our standard of care

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: No TBI: No TBI Before CAR T Cell InfusionExperimental treatment 1 intervention
Group B: TBI: TBI 2 Gy Before CAR T Cell InfusionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: