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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
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
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

  • 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.

Jennifer E Agrusa, MD contact

734-232-9335

jagrusa@med.umich.edu

United States1 site, 1 recruiting

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

    Jennifer E. Agrusa, 734-232-9335, jagrusa@med.umich.edu

    Jennifer E. Agrusa

    Recruiting

Other trials in United States

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

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 groups in NCT07532525
Study groupRoleWhat they receive
Treatment (pomalidomide)ExperimentalPatients 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.

  1. 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)

  1. CD19CART transgene expression

    Anti-CD19 (FMC63) CAR-T qPCR assay

    Measured: At days 0, 7, 14, 28, and 56

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted16 Apr 2026
  2. Study start26 Aug 2026
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

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)
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.

Questions about this trial

What is this clinical trial studying?

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.

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 14 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 15 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Jennifer E Agrusa, MD (734-232-9335, jagrusa@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: Within first 56 days following pomalidomide initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07532525.

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 15 Oct 2026.

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