BridgeMD
New treatment option for Recurrent B Acute Lymphoblastic Leukemia
Official title Pomalidomide After CAR T-cell Therapy for the Treatment of Relapsed or Refractory CD19+ B-cell Leukemia or Lymphoma
ClinicalTrials.gov ID: NCT07532525
What this study is testing
What is Pomalidomide?
Pomalidomide is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent b acute lymphoblastic leukemia.
Also referred to as 4-Aminothalidomide, Actimid.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject must have had a histologically or cytologically confirmed R/R CD19+ B-cell leukemia or lymphoma and have received a commercially available...
- 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%
You likely can't join if
- 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...
See the full eligibility 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...
- 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...
- Co-Enrollment: Willingness to consent/ co-enroll on BMT long term follow up study, HUM00043287 (UMCC2001-0234)
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.