Biological Insights of First Relapsed-refractory Patients With Mantle Cell Lymphoma: the MANTLE-FIRST BIO Study.

Launched by FONDAZIONE ITALIANA LINFOMI - ETS · May 6, 2021

Keywords

ClinConnect Summary

The MANTLE-FIRST BIO Study is a clinical trial focused on understanding the biological characteristics of patients with Mantle Cell Lymphoma (MCL) who have experienced a first relapse after treatment. Mantle Cell Lymphoma is a type of cancer that affects the lymphatic system. This study is looking for adults aged 18 to 80 who were diagnosed with MCL between January 2008 and June 2020 and have not responded to treatments that included rituximab and chemotherapy. Participants should have samples of their cancer tissue available for further study.

If you or a loved one qualifies for this trial, you can expect to provide consent and have your medical history reviewed. The researchers aim to gather important information that could help improve future treatments for MCL. It’s important to note that patients must have received specific treatments for their condition and should not be in a watchful waiting phase or have other types of lymphoma. This study may contribute valuable insights into how this cancer behaves after initial treatments, which could benefit future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with histologically documented diagnosis of Mantle Cell Lymphoma (MCL) as defined in the 2016 edition of the World Health Organization (WHO) classification, with available tissue for revision and additional studies;
• • Diagnosis of Mantle Cell Lymphoma (MCL) between 1st of January 2008 and 30th of June 2020;
• • Adults, 18-80 years at diagnosis;
• • Relapsed or refractory disease after rituximab and chemotherapy containing induction regimens with curative intent.
• • Treatment at relapse or progression on an intention-to-treat basis (ITT): at least one cycle of Chemo-immunotherapy (CIT), Bruton Tyrosine kinase inhibitors (BTKi), or alternative drugs combination;
• • Subject understanding and voluntarily signing an informed consent form approved by an Independent Ethics Committee (IEC), prior to the initiation of any study-specific procedures.
• Exclusion Criteria:
• • Unavailability of the samples requested by the study;
• • Any histology other than Mantle Cell Lymphoma (MCL);
• • Patients treated with front line regimens containing only rituximab or with palliative therapy;
• • Untreated patients; patients undergoing watchful waiting approach.