Les informations fournies par GHD, sous quelque forme que ce soit, ne visent pas à remplacer les avis médicaux, mais servent plutôt de guide et de plate-forme d’information sur les divers traitements et options disponibles. L'utilisation de toute information fournie par le site internet de GHD, ses employés, ses consultants ou toute autre personne en son nom est à vos propres risques et discrétion.

© 2019 de Global Healthcare Direct Limited

CAR T-Cell Immunotherapy for  Recurrent/Refractory Mantle Cell Lymphoma (MCL) 

Phase II Clinical Trial (ZUMA-2)

CAR-T treatments show promising results in a number of blood cancers, including Non-Hodgkin Lymphomas (NHLs). In-fact, the FDA already approved a CAR-T product for a 'relative' of MCL- the Diffuse Large B Cell Lymphoma. Based on some-what slimier expression of antigens between the different types of B cell NHL, CAR-T is now being evaluated for other NHL types also- including MCL. 

Clinical trials evaluating CAR-T for MCL patients are scarce when compared to other types of NHLs. Partly due to the rarity of this type of disease and the relatively recent 'clinical discovery' of CAR-T  treatments.

Phase II Open Clinical Trial 

Through both our partner hospitals in Beijing and the trial sponsor, Hebei Senlang BIOTECHNOLOGY Co., LTD, we at Global Healthcare Direct gained a direct access to the clinical trial recruitment process. 

Study Type: Interventional  (Clinical Trial)

Estimated Enrollment: 100 participants

Intervention Model Description: Single Group Assignment

Masking: Open-label trial

Primary Purpose: Treatment

Ages Eligible for Study:  18 Years and older (Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

How to apply for the Mantle Cell Lymphoma (MCL) CAR-T trial?

Fill in the below form. Add a short description of your case history and of your current condition. Our case manager will contact you shortly and guide you through.

Choosing to participate in a medical trial is an important personal decision.

Talk with your doctors and family members or friends about deciding to join a study!

Joindre un fichier +
Taille max du fichier 25MB

Inclusion Criteria:

  1. Up to 5 prior regimens for mantle cell lymphoma (MCL). Prior therapy must have included:

  • Anthracycline or bendamustine-containing chemotherapy and

  • Anti-CD20 monoclonal antibody therapy and

  • Ibrutinib or acalabrutinib

  1. At least 1 measurable lesion

  2. Platelet count ≥ 75,000/uL

  3. Creatinine clearance (as estimated by Cockcroft Gault) > 60 mL/min

  4. Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings

  5. Baseline oxygen saturation >92% on room air.

 

Exclusion Criteria:

  1. Known history of infection with HIV or hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per standard serological and genetic testing

  2. History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with central nervous system (CNS) involvement

  3. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.

 

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Et après ?

 

1.Contactez-nous: remplissez ce formulaire, envoyez un email ou appelez-nous.

2.Notre responsable de cas vous enverra un questionnaire sur les essais hospitaliers et vous assistera avec tous les documents médicaux nécessaires.

3.Nous vérifierons toutes les options et vous fournirons les plans de traitement et les prix. Nous vous aiderons à choisir la meilleure option.

4.Sur demande, nous pouvons vous aider à organiser vos vols et votre hébergement.

5.Notre accompagnateur personnel vous attendra à la porte des arrivées et vous accompagnera tout au long de votre traitement.

6.Nous vous ferons parvenir les documents de sortie traduits et resterons en contact avec vous après votre départ.

 

Toujours là pour vous,

L'équipe GHD

Joindre un fichier +
Taille max du fichier 25MB