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New treatment option for Diffuse Large B-cell Lymphoma Refractory
Official title Golcadomide Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse
ClinicalTrials.gov ID: NCT06271057
What this study is testing
What is golcadomide?
golcadomide is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for diffuse large b-cell lymphoma refractory.
Also referred to as BMS-986369, CC-99282.
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 study is an open-label, multicenter, proof of concept, phase 2 trial. Patients will be recruited over 18 months.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 18 months
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
- Patient who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments/procedures being conducted
- Adults patients (≥ 18-year-old at the time of signing the informed consent form; no upper age limit)
- Eligible for any commercialized market authorized anti-CD19 CAR T-cells
- Performance Status 0, 1, or 2
- With aggressive large B-cell lymphoma, including:
You likely can't join if
- History of malignancy other than non-melanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast) unless disease free for at least 3 years
- Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management; simple...
- History of human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B or C infection; people with history of hepatitis...
- Significant pulmonary function impairment and oxygen saturation (SaO2) \< 92% on room air
- Significant cardiovascular disease such as New York Heart Association Class III or IV or Objective Class C or D cardiac disease (see appendix 07)
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months...
See the full eligibility criteria
- Patient who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments/procedures being conducted
- Adults patients (≥ 18-year-old at the time of signing the informed consent form; no upper age limit)
- Eligible for any commercialized market authorized anti-CD19 CAR T-cells
- Performance Status 0, 1, or 2
- With aggressive large B-cell lymphoma, including:
- diffuse large B-cell lymphoma
- Primary mediastinal B-cell lymphoma
- Any transformed follicular or marginal zone lymphoma
- high-grade B-cell lymphoma (HGBL) Note: patients with Central Nervous System (CNS) involvement could be included but not patients with primary CNS lymphoma
- Available biopsy for centralized review
- With a CAR T-cells indication as soon as 2nd line treatment no later than in 4th line, previously validated by the multidisciplinary tumor board Note: Any treatment performed prior to leukapheresis is considered a line...
- Total MetabolicTumor Volume (TMTV) \> 80 ml, measured by centralized review, on standard18FDG-PET (positron emission tomography) done just before starting CAR T-cells procedure (i.e., D-13 +/- 4 days before...
- Creatinine clearance (as estimated by Modification of Diet in Renal Disease (MDRD) if \> 60-year-old or Cockcroft-Gault if \ 45 mL/min,
- Adequate hepatic function:
- aspartate aminotransferase/alanine aminotransferase (ALT/AST) ≤ 3.0 x ULN. (Note: In the case of documented liver involvement by lymphoma, ALT/AST must be ≤ 5.0 x ULN)
- Serum total bilirubin ≤ 2.0 mg/dL (34 μmol/L) (Note: In the case of Gilbert's syndrome, or documented liver or pancreatic involvement by lymphoma, serum total bilirubin must be ≤ 3.0 mg/dL (51 μmol/L))
- Patient covered by any social security system (France)
- Patient who understands and speaks one of the country official languages, unless local regulation authorizes independent translators
- Contraception:
- For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one highly effective method, as soon as consent...
- History of malignancy other than non-melanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast) unless disease free for at least 3 years
- Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management; simple urinary tract infection and uncomplicated bacterial pharyngitis are...
- History of human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B or C infection; people with history of hepatitis infection must have cleared their infection as determined by standard...
- Significant pulmonary function impairment and oxygen saturation (SaO2) \< 92% on room air
- Significant cardiovascular disease such as New York Heart Association Class III or IV or Objective Class C or D cardiac disease (see appendix 07)
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrollment
- History of severe immediate hypersensitivity reaction to any of the agents used in this study
- Current treatment with strong CYP3A4/5 modulators (see appendix 13)
- Pregnant, planning to become pregnant or lactating Women of Child Bearing Potential
- Any significant medical conditions, laboratory abnormality or psychiatric illness likely to interfere with participation in this clinical study (according to the investigator's decision)
- Person deprived of his/her liberty by a judicial or administrative decision
- Person hospitalized without consent
- Adult person under legal protection
The study team makes the final eligibility decision.
Where it's taking place
- Créteil, France
- Dijon, France
- La Tronche, France
- Lille, France
- Marseille, France
- Montpellier, France
- Nantes, France
- Paris, France
- Pessac, France
- Rennes, France
- Rouen, France
- Toulouse, France
- Vandœuvre-lès-Nancy, France
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 study runs about 18 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Créteil, France; Dijon, France; La Tronche, France; Lille, France; Marseille, France; Montpellier, France and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.