Actively Recruiting
CAR-T-cell Treatment for Untreated High Risk MANtle Cell Lymphoma
Led by Christian Schmidt, MD · Updated on 2024-07-01
150
Participants Needed
2
Research Sites
410 weeks
Total Duration
On this page
Sponsors
C
Christian Schmidt, MD
Lead Sponsor
J
Johannes Gutenberg University Mainz
Collaborating Sponsor
AI-Summary
What this Trial Is About
First-line CAR-T-cell consolidation after an abbreviated induction with 2 cycles of Rituximab and Ibrutinib prior to CAR-T-cell treatment and followed by 6 months of maintenance with Ibrutinib in patients with high risk MCL.
CONDITIONS
Official Title
CAR-T-cell Treatment for Untreated High Risk MANtle Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of Mantle Cell Lymphoma with cyclin D1 overexpression or t(11;14) presence
- At least one high-risk MCL feature: high or high-intermediate MIPI-c risk or TP53 mutation/overexpression
- No prior treatment for Mantle Cell Lymphoma
- Stage II to IV disease according to Ann Arbor classification
- Age between 18 and 75 years
- At least one measurable lesion as per Lugano Response Criteria
- ECOG performance status of 2 or less
- Adequate laboratory values including neutrophil count, platelets, creatinine, liver enzymes, and bilirubin
- No evidence of central nervous system disease
- Ability to provide written informed consent and comply with study visits
- Agreement to use effective contraception if of child-bearing potential
- Negative pregnancy test for females of childbearing potential
- Willingness to avoid driving for 8 weeks after CAR-T-cell treatment
- Ability to reach study site within 2 hours in case of emergency
You will not qualify if you...
- Unable to give informed consent or lack legal capacity
- Known hypersensitivity to investigational drugs or related compounds
- Participation in another investigational drug study within 30 days prior to enrollment
- Physical or psychiatric conditions that pose risk or interfere with study participation
- Known or persistent substance abuse
- Serious concomitant diseases such as significant cardiovascular conditions, oxygen saturation 92% or less, non-lymphoma pleural effusion, or uncontrolled diabetes
- Current or planned pregnancy or nursing
- Other active malignancies unless disease-free for at least 3 years
- Uncontrolled infections requiring IV antimicrobials
- Positive chronic hepatitis B or active hepatitis C infection
- Known HIV infection
- History of CNS disorders or autoimmune diseases requiring immunosuppression within last 2 years
- History of recent deep vein thrombosis or pulmonary embolism
- Known severe primary immunodeficiency
- Any condition interfering with safety or efficacy assessment
- Receipt of live vaccine within 6 weeks prior to study
- Conditions that may hamper compliance with study protocol and follow-up schedule
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University Hospital of Mainz
Mainz, Germany
Actively Recruiting
2
Klinikum der Universität München
Munich, Germany, 81377
Actively Recruiting
Research Team
M
Martin Dreyling, MD
CONTACT
C
Christian Schmidt, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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