Pomalidomide After CAR T-cell Therapy for the Treatment of Relapsed or Refractory CD19+ B-cell Le… (NCT07532525) | Clinical Trial Compass
RecruitingPhase 1
Pomalidomide After CAR T-cell Therapy for the Treatment of Relapsed or Refractory CD19+ B-cell Leukemia or Lymphoma
United States12 participantsStarted 2026-07-01
Plain-language summary
This phase I trial tests the safety and effectiveness of pomalidomide after CD19 chimeric antigen receptor T-cell (CD19CART) therapy for the treatment of patients with CD19+ B-cell leukemias or lymphomas that have come back after a period of improvement (relapsed) or do not respond to treatment (refractory). Chimeric antigen receptor (CAR) T-cell therapy is a type of treatment in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells and are then re-infused into the patient. Following CAR T-cell infusion, CAR T-cells must expand and persist in the blood stream in order to most effectively treat leukemia/lymphoma. Pomalidomide stops the growth of blood vessels, stimulates the immune system, and may kill cancer cells. Research has shown that drugs like pomalidomide can modify the immune system and increase the number or improve the function of CAR T-cells in the blood. Pomalidomide may enhance the treatment effects of CAR T-cell therapy in patients who have received CD19CART therapy for relapsed or refractory CD19+ B-cell leukemia or lymphoma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject must have had a histologically or cytologically confirmed R/R CD19+ B-cell leukemia or lymphoma and have received a commercially available CAR-T product approved to treat R/R CD19+ Bcell leukemias and lymphomas.
* Subject must be 28 - 56 days post infusion of CD19CART product at time of enrollment.
* \>= 18 years in age at time of enrollment
* Subject is able to swallow pills/tablets
* Karnofsky or Lansky performance score of \>= 50%
* Absolute neutrophil count (ANC) \>= 750/mm\^3 (granulocyte colony stimulating factor allowed)
* Platelets \>= 50,000/mm\^3 (transfusion independent for \>= 7 days, defined as not receiving platelet transfusions for at least 7 days prior to enrollment, unless due to marrow involvement from primary malignancy \[thrombopoietin (TPO) mimetics allowed\])
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) per institution
* Alanine aminotransferase (ALT \[serum glutamate pyruvate transaminase (SGPT)\]) =\< 3 x institutional ULN per institution
* Serum albumin \>= 2.0 g/dL
* Creatinine clearance (Cockcroft-Gault equation) \>= 30 mL/min/1.73 m\^2
* Sexually active females capable of becoming pregnant and males must agree to participate in the pomalidomide Risk Evaluation and Mitigation Strategy (REMS) program
* Patients must agree not to donate blood during treatment with pomalidomide and for 4 weeks following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must no…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events
Timeframe: Within first 56 days following pomalidomide initiation