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CARMOD - Golcadomide (BMS-986369) post-CAR T-cell in R/R Aggressive large B-cell lymphoma patients with high risk of relapse
EU CTIS ID: 2023-506705-20-00
What this study is testing
to estimate the efficacy of golcadomide administered post-anti-CD19 CAR T-cell infusion
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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
- Adequate hepatic function: 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
- 13. Contraception (refer to section 14.7): • For women of childbearing potential (WOCP): 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 is signed, during the treatment period (including periods of treatment interruption), and for at least 28 days after the last dose of golcadomide. Women must refrain from donating eggs during this same period. • For men: during the treatment period (including periods of treatment interruption) and for at least 28 days after the last dose of golcadomide, male subjects must: o With female partners of childbearing potential: use a condom associated to a highly effective method of contraception or remain abstinent (refrain from heterosexual intercourse) o With pregnant female partners: use a condom or remain abstinent (refrain from heterosexual intercourse) Men must refrain from donating sperm during this same period.
- Adult patients (≥ 18-year-old at the time of signing the informed consent form; no upper age limit)
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
- Pregnant, planning to become pregnant or lactating WOCBP (See definition section 14.6.1.1)
- 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
See the full eligibility criteria
Who can join
- Patient who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments/procedures being conducted
- Adequate hepatic function: 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
- 13. Contraception (refer to section 14.7): • For women of childbearing potential (WOCP): 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 is signed, during the treatment period (including periods of treatment interruption), and for at least 28 days after the last dose of golcadomide. Women must refrain from donating eggs during this same period. • For men: during the treatment period (including periods of treatment interruption) and for at least 28 days after the last dose of golcadomide, male subjects must: o With female partners of childbearing potential: use a condom associated to a highly effective method of contraception or remain abstinent (refrain from heterosexual intercourse) o With pregnant female partners: use a condom or remain abstinent (refrain from heterosexual intercourse) Men must refrain from donating sperm during this same period.
- Adult 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
- PS 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 CNS involvement could be included but not patients with primary CNS lymphoma
- Available biopsy for centralized review Note: if several previous biopsies exist, the last one will be the one to be transmitted. If this biopsy has already been reviewed by LYSARC, the result of this review can be used for this patient
- 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 and in compliance with marketing authorization
- TMTV > 80 ml, measured by centralized review, on standard 18FDG-PET (positron emission tomography) done just before starting CAR-T procedure (i.e., before lymphodepletion)
- Creatinine clearance (as estimated by MDRD if > 60-year-old or Cockcroft-Gault if <60yo > 45 mL/min
What rules you out
- 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
- Pregnant, planning to become pregnant or lactating WOCBP (See definition section 14.6.1.1)
- 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
- 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
- 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 permitted if responding to active treatment and after consultation with the sponsor’s medical monitor
- History of human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B or C infection; subjects with history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America guidelines or applicable country guidelines
- History of allogeneic stem cell transplant complicated or not with active acute or chronic GVHD.
- Current treatment with strong CYP3A4/5 modulators (see appendix 13)
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.