Trial Title:
Golcadomide Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse
NCT ID:
NCT06271057
Condition:
Diffuse Large B-cell Lymphoma Refractory
Refractory Primary Mediastinal Large B-Cell Lymphoma
Refractory Transformed B-cell Non-Hodgkin Lymphoma
Refractory High Grade B-Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Conditions: Keywords:
eligible for CAR T-cells therapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
golcadomide
Description:
golcadomide 0.3 mg weekly from D+5 post CAR T-cells administration until D+166
Arm group label:
golcadomide post CAR T-cells
Other name:
BMS-986369
Other name:
CC-99282
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patient who understood and voluntarily signed and dated an informed consent prior to
any study-specific assessments/procedures being conducted
2. Adults patients (≥ 18-year-old at the time of signing the informed consent form; no
upper age limit)
3. Eligible for any commercialized market authorized anti-CD19 CAR T-cells
4. Performance Status 0 or 1
5. 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
6. Available biopsy for centralized review
7. 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 of treatment
8. Total MetabolicTumor Volume (TMTV) > 80 ml, measured by centralized review, on
18FDG-PET (positron emission tomography) done just before starting CAR T-cells
procedure (i.e., D-13 +/- 4 days before CAR-T cells infusion)
9. Creatinine clearance (as estimated by Modification of Diet in Renal Disease (MDRD)
if > 60-year-old or Cockcroft-Gault if <60yo) >45 mL/min,
10. 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))
11. Patient covered by any social security system (France)
12. Patient who understands and speaks one of the country official languages, unless
local regulation authorizes independent translators
13. 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 method with a failure rate of <1% per year, 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.
Exclusion Criteria:
1. 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
2. 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
3. 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
4. Significant pulmonary function impairment and oxygen saturation (SaO2) < 92% on room
air
5. Significant cardiovascular disease such as New York Heart Association Class III or
IV or Objective Class C or D cardiac disease (see appendix 07)
6. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina,
or other clinically significant cardiac disease within 6 months of enrollment
7. History of severe immediate hypersensitivity reaction to any of the agents used in
this study
8. Current treatment with strong CYP3A4/5 modulators (see appendix 13)
9. Pregnant, planning to become pregnant or lactating Women of Child Bearing Potential
10. Any significant medical conditions, laboratory abnormality or psychiatric illness
likely to interfere with participation in this clinical study (according to the
investigator's decision)
11. Person deprived of his/her liberty by a judicial or administrative decision
12. Person hospitalized without consent
13. Adult person under legal protection
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hopital Henri Mondor
Address:
City:
Créteil
Zip:
94010
Country:
France
Status:
Recruiting
Contact:
Last name:
François LEMONNIER
Email:
francois.lemonnier@aphp.fr
Investigator:
Last name:
François LEMONNIER, Doctor
Email:
Principal Investigator
Facility:
Name:
Chu Dijon Bourgogne
Address:
City:
Dijon
Zip:
21000
Country:
France
Status:
Recruiting
Contact:
Last name:
Amandine DURAND
Email:
amandine.durand@chu-dijon.fr
Investigator:
Last name:
Amandine DURAND, Doctor
Email:
Principal Investigator
Facility:
Name:
Chu de Grenoble
Address:
City:
La Tronche
Zip:
38700
Country:
France
Status:
Recruiting
Contact:
Last name:
Sylvain CARRAS
Email:
scarras@chu-grenoble.fr
Investigator:
Last name:
Sylvain CARRAS, Doctor
Email:
Principal Investigator
Facility:
Name:
Chru de Lille
Address:
City:
Lille
Zip:
59037
Country:
France
Status:
Recruiting
Contact:
Last name:
Franck MORSCHHAUSER
Email:
franck.morschhauser@chu-lille.fr
Investigator:
Last name:
Franck MORSCHHAUSER, Professor
Email:
Principal Investigator
Facility:
Name:
Institut Paoli Calmettes
Address:
City:
Marseille
Zip:
13273
Country:
France
Status:
Recruiting
Contact:
Last name:
Gabriel BRISOU
Email:
brisoug@ipc.unicancer.fr
Investigator:
Last name:
Gabriel BRISOU, Doctor
Email:
Principal Investigator
Facility:
Name:
Chu de Montpellier
Address:
City:
Montpellier
Zip:
34090
Country:
France
Status:
Recruiting
Contact:
Last name:
Charles HERBAUX
Email:
c-herbaux@chu-montpellier.fr
Investigator:
Last name:
Charles HERBAUX, Doctor
Email:
Principal Investigator
Facility:
Name:
Chu de Nantes
Address:
City:
Nantes
Zip:
44093
Country:
France
Status:
Recruiting
Contact:
Last name:
Benoit TESSOULIN
Email:
benoit.tessoulin@chu-nantes.fr
Investigator:
Last name:
Benoit TESSOULIN, Doctor
Email:
Principal Investigator
Facility:
Name:
Hopital Saint-Louis
Address:
City:
Paris
Zip:
75475
Country:
France
Status:
Recruiting
Contact:
Last name:
Catherine THIEBLEMONT
Email:
catherine.thieblemont@aphp.fr
Investigator:
Last name:
Catherine THIEBLEMONT, Professor
Email:
Principal Investigator
Facility:
Name:
Chu de Bordeaux
Address:
City:
Pessac
Zip:
33604
Country:
France
Status:
Recruiting
Contact:
Last name:
François-Xavier GROS
Email:
francois-xavier.gros@chu-bordeaux.fr
Investigator:
Last name:
François-Xavier GROS, Doctor
Email:
Principal Investigator
Facility:
Name:
Chu Pontchaillou
Address:
City:
Rennes
Zip:
35033
Country:
France
Status:
Recruiting
Contact:
Last name:
Roch HOUOT
Email:
roch.houot@chu-rennes.fr
Investigator:
Last name:
Roch HOUOT, Professor
Email:
Principal Investigator
Facility:
Name:
Centre Henri Becquerel
Address:
City:
Rouen
Zip:
76038
Country:
France
Status:
Recruiting
Contact:
Last name:
Fabrice JARDIN
Email:
fabrice.jardin@chb.unicancer.fr
Investigator:
Last name:
Fabrice JARDIN, Professor
Email:
Principal Investigator
Facility:
Name:
Iuct Oncopole
Address:
City:
Toulouse
Zip:
31059
Country:
France
Status:
Recruiting
Contact:
Last name:
Lucie OBERIC
Email:
oberic.lucie@iuct-oncopole.fr
Investigator:
Last name:
Lucie OBERIC, Doctor
Email:
Principal Investigator
Facility:
Name:
Chu Brabois
Address:
City:
Vandœuvre-lès-Nancy
Zip:
54511
Country:
France
Status:
Recruiting
Contact:
Last name:
Arnaud CAMPIDELLI
Email:
A.CAMPIDELLI@chru-nancy.fr
Investigator:
Last name:
Arnaud CAMPIDELLI, Doctor
Email:
Principal Investigator
Start date:
June 14, 2024
Completion date:
October 20, 2027
Lead sponsor:
Agency:
The Lymphoma Academic Research Organisation
Agency class:
Other
Collaborator:
Agency:
Lymphoma Study Association
Agency class:
Other
Source:
The Lymphoma Academic Research Organisation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06271057
