A Prospective, Observational Cohort Study on the Clinical Impact of Novel Monoclonal Antibodies in B-cell Non-Hodgkin Lymphoma in Italian Clinical Practice (FIL_MAB)
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| ClinicalTrials.gov Identifier: NCT06008691 |
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Recruitment Status :
Not yet recruiting
First Posted : August 23, 2023
Last Update Posted : August 23, 2023
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| Condition or disease | Intervention/treatment |
|---|---|
| Non-Hodgkin Lymphoma, B-cell | Drug: "novel" MAB (alone or in combination) |
This is a large prospective, observational cohort study aimed at collecting clinical information on use, feasibility, short- and long-term efficacy and short- and long-term toxicity of novel MAB that have received approval from EMA since 2020 and are prescribed according to the indications for use authorized for marketing in Italy.
Patients entering the study will be subdivided into different cohorts based on approved treatment indications, type of antibody employed and histological subtype. Additional sub-cohorts will be defined if needed.
Final outputs will be based according to:
- Per indication analysis;
- Pooled analyses by type of antibody and subtype and other parameters;
- A general analysis of the whole cohort.
| Study Type : | Observational |
| Estimated Enrollment : | 1500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | A Prospective, Observational Cohort Study to Evaluate the Clinical Impact of Novel Monoclonal Antibodies (MAB) in B-cell Non-Hodgkin Lymphoma (NHL) in Italian Clinical Practice |
| Estimated Study Start Date : | October 2023 |
| Estimated Primary Completion Date : | October 2038 |
| Estimated Study Completion Date : | October 2038 |
| Group/Cohort | Intervention/treatment |
|---|---|
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B-cell NHL patients treated with novel MAB in Italian real life (approved by EMA and AIFA).
B-cell NHL patients treated with novel MAB in Italian real life (approved by EMA since 2020 and prescribed according to the indications for use authorized for marketing in Italy). Patients first-line and relapsed or refractory who had received at least 1 dose of MAB. Different cohorts will be analyzed according to approved treatment indications, type of antibody employed and NHL hystotypes. |
Drug: "novel" MAB (alone or in combination)
"novel" MAB (alone or in combination) based on presence of an EMA clinical indication since 2020 and prescribed according to the indications for use authorized for marketing in Italy |
- Overall response rate (ORR) [ Time Frame: At least 5 years ]ORR will be defined according to Lugano 2014 criteria as the proportion of patients who have a partial response (PR) or complete response to therapy (CR+PR).
- Complete Response rate (CRR) [ Time Frame: At least 5 years ]CRR will be defined according to Lugano 2014 criteria and will include only patients who achieved a CR at the end of treatment program. The best overall response will be defined as the best response between the date of beginning of therapy and the last restaging. Patients without response assessment (due to whatever reason) will be considered as non-responders.
- Progression free survival (PFS) [ Time Frame: At least 5 years ]PFS is defined as the time between the date of enrollment and the first documentation of recurrence, progression or death from any cause; responding patients and patients who are lost to follow up will be censored at their last assessment date.
- Overall survival (OS) [ Time Frame: At least 5 years ]OS is defined as the time between the start of treatment until death from any cause; patients who are lost at follow up will be censored at their last assessment date.
- Event free survival (EFS) [ Time Frame: At least 5 years ]ESFS is defined as the time from start of treatment to disease progression, death, or discontinuation of treatment for any reason (e.g. toxicity, patient preference), or initiation of a new treatment without documented progression.
- Time-to-next treatment (TTNT) [ Time Frame: At least 5 years ]TTNT represents the interval from commencement of one treatment to initiation of the next line of therapy.
- non-relapse mortality (NRM) [ Time Frame: At least 5 years ]NRM is defined as death without recurrent or progressive disease after treatment.
- Duration of response (DOR) [ Time Frame: At least 5 years ]DOR is defined as the time from the first documentation of tumor response (CR/PR) to disease progression or death according to Lugano 2014 criteria.
- Incidence of Early/Late Adverse Events [ Time Frame: At least 5 years ]
Toxicities will be recorded and classified according to the definitions of the latest version of the NCI CTCAE. Toxicity events will be determined by the incidence of severe, life-threatening (CTCAE grade 3, 4 and 5) and/or serious adverse events (SAEs) commencing after the first induction dose or at any time during therapy. Early and toxic deaths and cause of any death. Special focus on second tumors, infections and autoimmune complications. Particularly:
- Hematological and extra-hematological toxicities Grade > 2
- Infusional adverse events, will be recorded any Grade
- Toxicities of specific interest on second tumors, infections and autoimmune complications will be recorded any Grade
- Early and toxic deaths and cause of any death.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- Patients with diagnosis of B-cell NHL and need of treatment (as per guideline indications), both first-line and relapsed or refractory.
- Patients aimed to be treated in indication with a "novel" MAB (alone or in combination) based on presence of an EMA clinical indication since 2020 and prescribed according to the indications for use authorized for marketing in Italy.
- Signed written informed consent.
Exclusion Criteria:
- Being involved in a prospective interventional trial outside indication.
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Patients treated outside approved indications:
- 648-approved indication.
- 5% AIFA support.
- Compassionate use.
- Age less than 18 years.
- Inability to provide an informed consent.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06008691
| Contact: Uffici Studi FIL | +390131033153 | startup@filinf.it | |
| Contact: Uffici Studi FIL | +390599769913 | gestionestudi@filinf.it |
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| Principal Investigator: | Marco Ladetto, Prof. | AO SS Antonio e Biagio e Cesare Arrigo, Alessandria |
| Responsible Party: | Fondazione Italiana Linfomi - ETS |
| ClinicalTrials.gov Identifier: | NCT06008691 |
| Other Study ID Numbers: |
FIL_MAB |
| First Posted: | August 23, 2023 Key Record Dates |
| Last Update Posted: | August 23, 2023 |
| Last Verified: | August 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Non-Hodgkin Lymphoma B-cell monoclonal antibodies novel antibodies |
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Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |