Recurrent B Acute Lymphoblastic LeukemiaPhase 1NCT07532525
Pomalidomide After CAR T-cell Therapy for the Treatment of Relapsed or Refractory CD19+ B-cell Leukemia or Lymphoma
A Phase 1 study testing Biospecimen Collection and Pomalidomide in people with Recurrent B Acute Lymphoblastic Leukemia and Recurrent B-Cell Non-Hodgkin Lymphoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent B Acute Lymphoblastic Leukemia, Recurrent B-Cell Non-Hodgkin Lymphoma, Refractory B Acute Lymphoblastic Leukemia
- What is being tested?
- Biospecimen Collection and Pomalidomide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2026to Aug 2028
- Phase
- Phase 1
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
- 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 performance score of >= 50%
- Absolute neutrophil count (ANC) >= 750/mm^3 (granulocyte colony stimulating factor allowed)
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- 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 not be exposed to pomalidomide
- Co-Enrollment: Willingness to consent/ co-enroll on BMT long term follow up study, HUM00043287 (UMCC2001-0234)
Who cannot join
- Patients with known progressive or refractory disease.
- The following transplant or CAR T-related events are excluded:
- Active grade >= 2 acute or chronic graft versus host disease (GVHD)
- Active cytokine release syndrome (CRS) grade >= 2
- Active immune effector cell associated neurotoxicity (ICANS) grade >= 2
- Subject receiving >= 0.25 mg/kg/day of methylprednisolone equivalent. Subject being treated with medications with a known major drug interaction to pomalidomide. Specifically, patients receiving CYP1A2 inhibitors, such as ciprofloxacin, omeprazole, cimetidine, estrogen, and fluvoxamine.
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- Patient who smokes cigarettes.
- Subject must not have initiated or received intervening therapy for a primary or secondary malignancy within 28 days of study enrollment, including, a) myelosuppressive chemotherapy, b) biologic anti-neoplastic agents (e.g., ruxolitinib, imatinib, dasatinib…), or checkpoint inhibitors (e.g., pembrolizumab). The use of cytokine inhibition for management of CRS/ICANS is allowed within the prior 28 days
- Receipt of radiation therapy (XRT) (focal or large field, including cranial or cranial-spinal) within 28 days prior to enrollment
- Stem cell transplant or rescue following most recent CD19CART therapy
- History of allergic reactions to pomalidomide or any of the excipients and any similar compounds
- Intercurrent illness or conditions:
- Patients with uncontrolled infections. In addition, patients with any documented bacteremia, fungemia, or new onset viremia that requires antimicrobial therapy within 72 hours prior to enrollment. Empiric antimicrobials are allowed
- Active grade >= 4 gastrointestinal, hepatic, pulmonary, renal, cardiac toxicity by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 criteria. Patients requiring dialysis are excluded
- Patients with concomitant genetic syndromes associated with bone marrow failure states: such as patients with Fanconi anemia, severe congenital neutropenia, Schwachman syndrome or any other known bone marrow failure syndrome. Patients with Down syndrome are not excluded
- History of known prior arterial thromboembolism, venous thromboembolism, pulmonary embolism, cardiovascular accidents, or myocardial infarctions within 3 months prior to enrollment
- Pregnant women are excluded from this study. Women should discontinue breastfeeding during treatment and for at least 4 weeks after discontinuation of study drug
- HIV positivity within 8 weeks of screening on polymerase chain reaction (PCR) based assay
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, 1 recruiting
- Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Jennifer E. Agrusa, 734-232-9335, jagrusa@med.umich.edu
Jennifer E. Agrusa
About this study
Official title: A Single-Center, Single-Arm, Phase 1 Pilot Study of Pomalidomide Following CD19-Directed Chimeric Antigen Receptor T-Cell Therapy in Relapsed/Refractory CD19+ B-Cell Leukemias and Lymphomas
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.
Read the detailed description
01JUL2026- Amendment was approved to remove the Duration of Response objective and update some of the inclusion/exclusion criteria
- Conditions
- Recurrent B Acute Lymphoblastic Leukemia, Recurrent B-Cell Non-Hodgkin Lymphoma, Refractory B Acute Lymphoblastic Leukemia, Refractory B-Cell Non-Hodgkin Lymphoma
- Being tested
- Biospecimen Collection, Pomalidomide
- Medical subject headings
- Burkitt Lymphoma, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood samples
PomalidomideDrug
Also called 4-Aminothalidomide, Actimid, CC 4047, CC-4047
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (pomalidomide) | Experimental | Patients receive pomalidomide PO QD for 10 doses in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples on study. Receives: Procedure: Biospecimen Collection; Drug: Pomalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Will assess the safety and tolerability of pomalidomide following CD19 chimeric antigen receptor T-cell (CD19CART) therapy for recurrent/refractory B-cell leukemia/lymphoma. Hematologic and non-hematologic toxicity within the first 56 days following the initiation of pomalidomide will be monitored. All observed toxicities, including dose-limiting toxicity will be summarized in terms of type (organ affected or laboratory determination), severity (by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0), duration, and reversibility or outcome. Tables will be created to summarize toxicities.
Measured: Within first 56 days following pomalidomide initiation
Secondary outcomes (6)
CD19CART transgene expression
Anti-CD19 (FMC63) CAR-T qPCR assay
Measured: At days 0, 7, 14, 28, and 56
CD19CART transgene expression
A Spaghetti plot of individual transgene expression levels will be presented through 1-year post-pomalidomide initiation, with a population average superimposed on the plot.
Measured: At 1 year
Overall survival
Kaplan-Meier estimates with confidence intervals will be presented and proportions will be accompanied by 95% confidence intervals. Subject to available event rates for model convergence, a Cox proportional hazards model with transgene expression as a continuous predictor will be used to explore potential association with overall survival.
Measured: Up to 1 year
Event-free survival (EFS)
1-year EFS estimates with confidence intervals will be presented and proportions will be accompanied by 95% confidence intervals. Events will be defined as disease relapse, progression, or death due to any cause.
Measured: Up to 1 year
Lymphocyte profiles
Immunophenotyping of lymphocyte profiles will be plotted via a Spaghetti plot with a heat map color scheme to correlate T-cell differentiation profiles with CD19CART transgene expression at the concurrent time points.
Measured: At baseline and days 7, 14, 28, and 56
Serum cytokine and chemokine levels
Will be plotted via a Spaghetti plot with a heat map color scheme to correlate cytokine/chemokine levels with CD19CART transgene expression at the concurrent time points.
Measured: At baseline and days 7, 14, 28, and 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start26 Aug 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent B Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer E Agrusa, MD, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532525
- Sponsor's protocol ID
- UMCC 2025.011
- Other IDs
- NCI-2026-00885, HUM00273237
- Status last verified
- Oct 2026
- First submitted
- 9 Apr 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual subject data will not be provided; however, our cumulative findings based upon response and survival for the entire population will be provided.