Actively Recruiting
Golcadomide Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse
Led by The Lymphoma Academic Research Organisation · Updated on 2024-10-15
65
Participants Needed
13
Research Sites
174 weeks
Total Duration
On this page
Sponsors
T
The Lymphoma Academic Research Organisation
Lead Sponsor
L
Lymphoma Study Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is an open-label, multicenter, proof of concept, phase 2 trial. Patients will be recruited over 18 months. Safety analysis will be performed with a stop of the enrollment after 3 patients have either 1 complete treatment cycle or permanently discontinued treatment whichever occurs first. Approximatively 65 patients with aggressive large B-cell lymphoma (LBCL) (including diffuse large B-cell lymphoma (DLBCL), Primary mediastinal B-cell lymphoma (PMBCL), any transformed follicular or marginal zone lymphoma, high-grade B-cell lymphoma (HGBL)) will be enrolled in the study. The duration of treatment with golcadomide (CELMoD) is 24 weeks with 6 cycles of 28 days (4 weeks), starting at 5 days after CAR-T cells infusion. The primary objective of the study is to estimate the efficacy of golcadomide administered post-anti-CD19 CAR T-cell infusion, Efficacy determination will be based upon the primary endpoint of complete metabolic response (CMR) rate at 3 months after infusion of anti-CD19 CAR T-cell assessed by study investigator.
CONDITIONS
Official Title
Golcadomide Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient understood and signed informed consent before any study procedures
- Adults aged 18 years or older with no upper age limit
- Eligible for approved anti-CD19 CAR T-cell therapies
- Performance status of 0 or 1
- Diagnosis of aggressive large B-cell lymphoma, including diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed follicular or marginal zone lymphoma, or high-grade B-cell lymphoma (patients with CNS involvement except primary CNS lymphoma may be included)
- Available biopsy for centralized review
- Indication for CAR T-cell therapy as 2nd to 4th line treatment, validated by tumor board
- Total Metabolic Tumor Volume over 80 ml measured by 18FDG-PET before CAR T-cell infusion
- Creatinine clearance over 45 mL/min
- Adequate liver function with ALT/AST less than or equal to 3 times upper limit of normal (up to 5 times if liver involved by lymphoma) and bilirubin less than or equal to 2.0 mg/dL (up to 3.0 mg/dL in Gilbert's syndrome or liver/pancreatic involvement)
- Covered by social security in France
- Understands and speaks an official country language or uses authorized translators
- Women of childbearing potential agree to abstain or use two effective contraception methods during treatment and 28 days after last dose and refrain from egg donation
You will not qualify if you...
- History of other malignancy except non-melanoma skin cancer or carcinoma in situ unless disease-free for 3 years
- Uncontrolled or serious infections requiring IV antimicrobials (simple urinary tract infections or uncomplicated pharyngitis allowed if responding to treatment)
- History of HIV or active hepatitis B or C infection; hepatitis must be cleared per guidelines
- Significant lung impairment or oxygen saturation below 92% on room air
- Significant heart disease including severe heart failure or recent major cardiac events within 6 months
- Severe allergic reactions to study agents
- Current treatment with strong CYP3A4/5 modulators
- Pregnant, planning pregnancy, or breastfeeding women
- Any medical, lab, or psychiatric condition that may interfere with study participation
- Persons deprived of liberty by judicial or administrative decision
- Persons hospitalized without consent
- Adults under legal protection
AI-Screening
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Trial Site Locations
Total: 13 locations
1
Hopital Henri Mondor
Créteil, France, 94010
Actively Recruiting
2
Chu Dijon Bourgogne
Dijon, France, 21000
Actively Recruiting
3
Chu de Grenoble
La Tronche, France, 38700
Actively Recruiting
4
Chru de Lille
Lille, France, 59037
Actively Recruiting
5
Institut Paoli Calmettes
Marseille, France, 13273
Actively Recruiting
6
Chu de Montpellier
Montpellier, France, 34090
Actively Recruiting
7
Chu de Nantes
Nantes, France, 44093
Actively Recruiting
8
Hopital Saint-Louis
Paris, France, 75475
Actively Recruiting
9
Chu de Bordeaux
Pessac, France, 33604
Actively Recruiting
10
Chu Pontchaillou
Rennes, France, 35033
Actively Recruiting
11
Centre Henri Becquerel
Rouen, France, 76038
Actively Recruiting
12
Iuct Oncopole
Toulouse, France, 31059
Actively Recruiting
13
Chu Brabois
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
Research Team
S
Stéphanie DOYEN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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