RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Following CAR T-cell infusion, CAR T-cells must expand and persist in the blood stream in order to most effectively treat leukemia/lymphoma."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe pomalidomide is and how well it works after CAR T-cell therapy, which uses changed immune cells to attack cancer. It is for adults with CD19-positive B-cell leukemia or lymphoma that came back or did not respond to treatment before CAR T-cell therapy.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older, with CD19-positive B-cell leukemia or lymphoma confirmed by tissue or cell tests.
  • Have received an approved, commercially available CD19 CAR T-cell treatment 28–56 days before joining.
  • Be able to swallow pills and have a daily activity score of at least 50 on the Karnofsky scale.
  • Have enough infection-fighting white blood cells and platelets, which help blood clot. Rules about recent platelet transfusions also apply.
  • Meet the study’s blood protein, liver, and kidney test limits.
  • If sexually active, men and women who can become pregnant must join the drug’s required safety program.
  • Agree not to donate blood during treatment or for 4 weeks after stopping the drug.
  • Agree to join the required long-term follow-up study.

Who can't join

  • Cancer is known to be getting worse or not responding to treatment.
  • Have active grade 2 or worse transplant or CAR T-cell side effects: donor cells attacking the body, an immune overreaction, or brain and nerve problems.
  • Smoke cigarettes, take steroids at or above the study’s dose limit, or take medicines with major interactions with pomalidomide.
  • Had certain cancer treatments or radiation within 28 days before joining, or a stem cell transplant or rescue after the latest CAR T-cell therapy.
  • Have an allergy to pomalidomide, its ingredients, or similar drugs.
  • Have an uncontrolled infection, certain recent bloodstream infections, very severe organ side effects, need dialysis, or have an inherited condition that causes bone marrow failure. Down syndrome alone does not exclude you.
  • Had a blood clot, stroke, or heart attack within 3 months before joining, or a positive HIV PCR test within 8 weeks of screening.
  • Are pregnant. Breastfeeding must stop during treatment and for at least 4 weeks after stopping the drug.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 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 Criteria: * 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

Study sites (1)

MI