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New treatment option for Cytopenia
Official title A Pilot Study of Emapalumab for the Treatment of CAR T-Cell Therapy-Associated Prolonged Cytopenia
ClinicalTrials.gov ID: NCT06285825
What this study is testing
What is Emapalumab?
Emapalumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cytopenia.
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
- To look at the safety and effectiveness of emapalumab for the treatment of prolonged severe cytopenia in participants with LBCL who receive CART.
- Phase 2: a mid-size study of how well it works
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
- Eligible participants will be considered for inclusion in this study if they meet the following criteria based on tests obtained less than 4 weeks...
- Relapsed or refractory FL (grade 1, 2, 3a and 3b), MCL, DLBCL, PMBCL, tFL, or HGBCL
- Received standard of care therapy with axi-cel, tisa-cel or liso-cel
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
You likely can't join if
- Participants will be ineligible for this study if they meet the following criteria:
- History of malignancy other than nonmelanoma skin cancer or localized carcinoma (e.g., cervix, bladder, breast, prostate) unless disease free for at...
- History of Richter's transformation of chronic lymphocytic leukemia (CLL)
- Presence of grade 3-4 cytopenia before initiation of lymphodepleting chemotherapy for CART
- Grade 3-4 cytopenia due to use of experimental non-commercially available CART product
- Bone marrow evidence of LBCL, hypersplenism, HLH, or a second malignancy (e.g., MDS) that could be contributing to cytopenia, with no alternative...
See the full eligibility criteria
Who can join
- Eligible participants will be considered for inclusion in this study if they meet the following criteria based on tests obtained less than 4 weeks from first dose:
- Relapsed or refractory FL (grade 1, 2, 3a and 3b), MCL, DLBCL, PMBCL, tFL, or HGBCL
- Received standard of care therapy with axi-cel, tisa-cel or liso-cel
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Either in remission after CART and/or with refractory/progressive disease not requiring urgent treatment in the opinion of the treating physician
- Grade 3-4 cytopenia defined as either absolute neutrophil count of \< 1.0x109/L, or platelet count \< 50x109/L or haemoglobin\< 8 g/dL starting or persisting between day 30 and day 90 after CART
- Creatinine clearance (as estimated by Cockcroft Gault) ≥ 30 mL/min
- Serum alanine transaminase (ALT) / aspartate transaminase (AST) ≤ 2.5 upper limit of normal (ULN), independently from etiology
- Total bilirubin ≤1.5 mg/dL, or ≤ 3 UNLin participants with Gilbert's syndrome.
- Baseline oxygen saturation \> 92% on room air 11 Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal...
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure.
- Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy...
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of emapalumab administration. 14\...
What rules you out
- Participants will be ineligible for this study if they meet the following criteria:
- History of malignancy other than nonmelanoma skin cancer or localized carcinoma (e.g., cervix, bladder, breast, prostate) unless disease free for at least 3 years.
- History of Richter's transformation of chronic lymphocytic leukemia (CLL)
- Presence of grade 3-4 cytopenia before initiation of lymphodepleting chemotherapy for CART
- Grade 3-4 cytopenia due to use of experimental non-commercially available CART product
- Bone marrow evidence of LBCL, hypersplenism, HLH, or a second malignancy (e.g., MDS) that could be contributing to cytopenia, with no alternative, identifiable potential cause for the cytopenia.
- Relapsed or progressive disease requiring immediate initiation of anti-lymphoma treatment
- Known presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management, including leishmania infection. Simple UTI and uncomplicated bacterial pharyngitis are...
- Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). A history of HIV, hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative...
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrolment
- History of primary immunodeficiency
- History of symptomatic deep vein thrombosis or symptomatic pulmonary embolism within 1 month of enrolment considered significant in the opinion of the principal investigator
- Any medical condition likely to interfere with assessment of safety or how well it works of study treatment in the investigator's opinion
- History of severe immediate hypersensitivity reaction to any of the agents used in this study, including E coli-derived proteins.
- Receipt of BCG vaccine within 12 weeks prior screening or receipt of a live or attenuated (other than BCG) vaccine within 4 weeks prior to screening
- Women of child-bearing potential who are pregnant or breastfeeding.
- Women of child-bearing potential and men with partners who are of child-bearing potential who are not willing to practice birth control as noted in section 4.1 from the time of consent through 6 months after the...
- In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participationTrial Treatments
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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 Houston, Texas, 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.