Back to search results

Pomalidomide After CAR T-cell Therapy for Leukemia or Lymphoma

This study is testing if pomalidomide, a drug that can stop blood vessel growth and boost the immune system, is safe and effective when given after CAR T-cell therapy. CAR T-cell therapy is a treatment where your own immune cells are specially trained to fight cancer. This trial is for adults (18 and older) with B-cell leukemia or lymphoma that has come back or didn't respond to previous treatments, and who have already received a commercial CAR T-cell product. The main goal is to see how many side effects happen within the first 56 days after starting pomalidomide. This study plans to enroll 12 participants. The current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is designed to enroll 12 participants.
What's involved
Participants will undergo collection of blood samples. The trial record does not specify the frequency or duration of these procedures.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures adverse events within the first 56 days following pomalidomide initiation. The overall follow-up duration is not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07532525

Pomalidomide After CAR T-cell Therapy for the Treatment of Relapsed or Refractory CD19+ B-cell Leukemia or Lymphoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Michigan Rogel Cancer Center
~12 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:Biospecimen CollectionPomalidomide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Within first 56 days following pomalidomide initiation

Conditions

Recurrent B Acute Lymphoblastic Leukemia
Recurrent B-Cell Non-Hodgkin Lymphoma
Refractory B Acute Lymphoblastic Leukemia
Refractory B-Cell Non-Hodgkin Lymphoma

Explore related trials

Acute Lymphoblastic LeukemiaNon-Hodgkin Lymphoma

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Jennifer E Agrusa, MD · PRINCIPAL_INVESTIGATOR · University of Michigan Rogel Cancer Center

Who to contact

Jennifer E Agrusa, MD
[email protected]
734-232-9335
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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)
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)

Exclusion

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.
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

What this trial measures

  • Incidence of adverse eventsWithin first 56 days following pomalidomide initiation

    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.