Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06299553
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-02-22
Brief Title:
Study to Evaluate the Effectiveness of Tafasitamab in Combination With Lenalidomide Followed by Tafasitamab Monotherapy in Relapsed or Refractory Diffuse Large B-cell Lymphoma Non-transplant Eligible Patients in Italy PRO-MIND
Sponsor:
Incyte Biosciences Italy Srl
Organization:
Incyte Biosciences Italy Srl
Study Overview
Official Title:
INCB88888-040 Multicenter Prospective Real-world Observational Cohort Study to Evaluate the Effectiveness of Tafasitamab in Combination With Lenalidomide Followed by Tafasitamab Monotherapy in Relapsed or Refractory Diffuse Large B-cell Lymphoma Non-transplant Eligible Patients in Italy PRO-MIND
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The PRO-MIND study is an Italian multicenter prospective observational cohort study to evaluate the effectiveness and the safety of tafasitamab in combination with lenalidomide followed by tafasitamab monotherapy in patient with DLBCL
Detailed Description:
This is an Italian multicenter prospective observational cohort study to collect data on patients with non-transplant eligible RR DLBCL treated with tafasitamab plus lenalidomide followed by tafasitamab in monotherapy as second third and fourth treatment line in a real-world clinical practice setting
The study is non-interventional all treatment decisions are made at the discretion of the patients healthcare provider and are not mandated by the study design or protocol
Since this is an observational study of real-world treatment practices and outcomes no study medication will be provided as a part of this study Tafasitamab and lenalidomide will be provided through usual commercial channels for medicines prescription Tafasitamab and lenalidomide will not be provided free of charge by the sponsor
Physicians will make all treatment decisions according to their usual clinical practices and will provide prescriptions for their patients as appropriate The decision to treat the patient with tafasitamab must have been taken prior to and independently of the patients inclusion in the study There are no mandatory protocol procedures or diagnostic tests
This is a prospective observational study patients will be eligible to enter the study if the treatment with tafasitmab plus lenalidomide is started and when all the ethical and contract procedures with the site have been completed and after the site initiation visit date
The study will be performed in approximately 30 Italian sites distributed in the overall Italian territory
During this study patients must completed questionnaires of quality of life Questionnaires should be completed by the patient Electronic Patient Reported Outcome ePROat each applicable occasion Where possible in accordance with local clinical practice PROs should be completed before other assessments The following measures are requested to be recorded
EORTC-QLQ-C30 Version 3
EORTC QLQ NHL-HG29
The standardized EORTC QLQ-C30 questionnaire v 30 was used to assess the HRQoL of cancer patients The questionnaire contains questions regarding the impact of the disease on different areas of a patients life physical role emotional cognitive and social functioning the occurrence of symptoms fatigue nausea and vomiting pain dyspnea insomnia appetite loss constipation and diarrhea financial difficulties and an overall assessment of HRQoL Appendix 4 Aaronson NK Ahmedzai S Bergman B et al 1993 For each question the respondent must choose 1 answer For 28 of the questions the answers are given on a 4-point Likert-type scale 1 - never 2 - sometimes 3 - often 4 - very often and assess the intensity of the analysed parameters The last 2 questions evaluate the general health of the patient on a 7-point scale from 1 - very bad to 7 - excellent Patients completed the questionnaires by themselves If a question arose they could ask the researcher for an explanation
After collecting the responses a raw score was calculated for each of the abovementioned 15 questionnaire items Next a linear transformation was performed to obtain a score in a range from 0 to 100 The conversion of the results to a 100-point scale was made according to the EORTC guidelines Of note a higher score on the functional scales means better functioning and a higher response for general health corresponds to a better HRQoL
The QLQ-HG-NHL29 consists of 29 items contributing to five multiitem subscales and three conditional items symptom burden due to disease andor treatment seven items neuropathy two items physical conditionfatigue five items emotional impacts four items and worries about health and functioning eight items The three conditional items which patients complete only if relevant to them are about having problems at workeducation worries about workeducation and concerns about the ability to have children Appendix 5 Van de Poll-Franse L Oerlemans S Bredart A et al 2018 Items are rated using a four-point response scale not at all a little quite a bit and very much and the reference time frame for all items is the past week14 The scoring approach for the QLQ-HG-NHL29 is identical to that of the EORTC QLQ-C30 ie calculating the mean of the items of a specific multi-item scale or using the single conditional item score and then converting it into a standardized scale ranging from 0 to 100 A higher score for all the multi-item scales and items represent a higher level of symptomatology or problems
HRQoL questionnaires will be filled out either at the hospital or during pre-scheduled medical office visits The questionnaires will be provided to the patient by a member of the study team at the scheduled times to coincide with other scheduled assessments or visits via standard paper copy administration However HRQoL electronic questionnaires administration may be allowed as a back-up procedure to maximize compliance Patients will be asked to fill out the questionnaires as completely and accurately as possible with an expected average time of completion around 10 minutes
A high compliance with HRQoL questionnaires throughout the study period is considered essential for the success of this observational study and local Investigators of participating centers will have to be properly informed and motivated towards the importance of collecting HRQoL data
Each participating center will be requested to submit a HRQoL Missing Data Form in lieu of a HRQoL questionnaire for any assessment that is not provided at the appropriate follow-up time point Compliance with HRQoL questionnaires over time will be monitored not for the purpose of informing clinical care of participants and if needed reminders will be sent to participating centers to solicit HRQoL data The compliance rate at each time point will be evaluated as the number of valid HRQoL questionnaires returned by eligible patients as a proportion of the total number of eligible patients available
In order to make the HRQoL component of the study as pragmatic as possible and not to undermine the data collection process across several centers HRQoL assessment is requested to take place in conjunction with the collection of effectiveness data foreseen for this protocol
Therefore HRQoL questionnaires will be administered at baseline before first tafasitamab administration and then every 3 months during the first year and then every 6 months thereafter unless the patient has a disease progression andor permanently discontinue treatment with tafasitamab The first HRQoL assessment after baseline would correspond to the end of the period where tafasitamab is administered on a weekly basis approximately at the end of cycle 3 hence with potential expected HRQoL detriments Thereafter starting from cycle 4 considering the infusions of tafasitamab will take place every 2 weeks HRQoL improvements although with not known magnitude could possibly be expected and captured in this study HRQoL will be assessed regardless of dose modification or temporary treatment interruption as long as the patient is considered on study according current protocol definition
In case of temporary treatment interruption
Continue HRQoL assessment as described in the above schedule of administration
In case of permanent treatment discontinuation with tafasitamab
HRQoL assessment should be performed at the time of discontinuation in any case as close as possible to the time of treatment discontinuation and then stopped afterwards
In case of disease progression
HRQoL assessment should be performed at the time of progression in any case as close as possible to the time of disease progression and then stopped afterwards
The study is non-interventional all treatment decisions are made at the discretion of the patients healthcare provider and are not mandated by the study design or protocol
Since this is an observational study of real-world treatment practices and outcomes no study medication will be provided as a part of this study Tafasitamab and lenalidomide will be provided through usual commercial channels for medicines prescription Tafasitamab and lenalidomide will not be provided free of charge by the sponsor
Physicians will make all treatment decisions according to their usual clinical practices and will provide prescriptions for their patients as appropriate The decision to treat the patient with tafasitamab must have been taken prior to and independently of the patients inclusion in the study There are no mandatory protocol procedures or diagnostic tests
This is a prospective observational study patients will be eligible to enter the study if the treatment with tafasitmab plus lenalidomide is started and when all the ethical and contract procedures with the site have been completed and after the site initiation visit date
The study will be performed in approximately 30 Italian sites distributed in the overall Italian territory
During this study patients must completed questionnaires of quality of life Questionnaires should be completed by the patient Electronic Patient Reported Outcome ePROat each applicable occasion Where possible in accordance with local clinical practice PROs should be completed before other assessments The following measures are requested to be recorded
EORTC-QLQ-C30 Version 3
EORTC QLQ NHL-HG29
The standardized EORTC QLQ-C30 questionnaire v 30 was used to assess the HRQoL of cancer patients The questionnaire contains questions regarding the impact of the disease on different areas of a patients life physical role emotional cognitive and social functioning the occurrence of symptoms fatigue nausea and vomiting pain dyspnea insomnia appetite loss constipation and diarrhea financial difficulties and an overall assessment of HRQoL Appendix 4 Aaronson NK Ahmedzai S Bergman B et al 1993 For each question the respondent must choose 1 answer For 28 of the questions the answers are given on a 4-point Likert-type scale 1 - never 2 - sometimes 3 - often 4 - very often and assess the intensity of the analysed parameters The last 2 questions evaluate the general health of the patient on a 7-point scale from 1 - very bad to 7 - excellent Patients completed the questionnaires by themselves If a question arose they could ask the researcher for an explanation
After collecting the responses a raw score was calculated for each of the abovementioned 15 questionnaire items Next a linear transformation was performed to obtain a score in a range from 0 to 100 The conversion of the results to a 100-point scale was made according to the EORTC guidelines Of note a higher score on the functional scales means better functioning and a higher response for general health corresponds to a better HRQoL
The QLQ-HG-NHL29 consists of 29 items contributing to five multiitem subscales and three conditional items symptom burden due to disease andor treatment seven items neuropathy two items physical conditionfatigue five items emotional impacts four items and worries about health and functioning eight items The three conditional items which patients complete only if relevant to them are about having problems at workeducation worries about workeducation and concerns about the ability to have children Appendix 5 Van de Poll-Franse L Oerlemans S Bredart A et al 2018 Items are rated using a four-point response scale not at all a little quite a bit and very much and the reference time frame for all items is the past week14 The scoring approach for the QLQ-HG-NHL29 is identical to that of the EORTC QLQ-C30 ie calculating the mean of the items of a specific multi-item scale or using the single conditional item score and then converting it into a standardized scale ranging from 0 to 100 A higher score for all the multi-item scales and items represent a higher level of symptomatology or problems
HRQoL questionnaires will be filled out either at the hospital or during pre-scheduled medical office visits The questionnaires will be provided to the patient by a member of the study team at the scheduled times to coincide with other scheduled assessments or visits via standard paper copy administration However HRQoL electronic questionnaires administration may be allowed as a back-up procedure to maximize compliance Patients will be asked to fill out the questionnaires as completely and accurately as possible with an expected average time of completion around 10 minutes
A high compliance with HRQoL questionnaires throughout the study period is considered essential for the success of this observational study and local Investigators of participating centers will have to be properly informed and motivated towards the importance of collecting HRQoL data
Each participating center will be requested to submit a HRQoL Missing Data Form in lieu of a HRQoL questionnaire for any assessment that is not provided at the appropriate follow-up time point Compliance with HRQoL questionnaires over time will be monitored not for the purpose of informing clinical care of participants and if needed reminders will be sent to participating centers to solicit HRQoL data The compliance rate at each time point will be evaluated as the number of valid HRQoL questionnaires returned by eligible patients as a proportion of the total number of eligible patients available
In order to make the HRQoL component of the study as pragmatic as possible and not to undermine the data collection process across several centers HRQoL assessment is requested to take place in conjunction with the collection of effectiveness data foreseen for this protocol
Therefore HRQoL questionnaires will be administered at baseline before first tafasitamab administration and then every 3 months during the first year and then every 6 months thereafter unless the patient has a disease progression andor permanently discontinue treatment with tafasitamab The first HRQoL assessment after baseline would correspond to the end of the period where tafasitamab is administered on a weekly basis approximately at the end of cycle 3 hence with potential expected HRQoL detriments Thereafter starting from cycle 4 considering the infusions of tafasitamab will take place every 2 weeks HRQoL improvements although with not known magnitude could possibly be expected and captured in this study HRQoL will be assessed regardless of dose modification or temporary treatment interruption as long as the patient is considered on study according current protocol definition
In case of temporary treatment interruption
Continue HRQoL assessment as described in the above schedule of administration
In case of permanent treatment discontinuation with tafasitamab
HRQoL assessment should be performed at the time of discontinuation in any case as close as possible to the time of treatment discontinuation and then stopped afterwards
In case of disease progression
HRQoL assessment should be performed at the time of progression in any case as close as possible to the time of disease progression and then stopped afterwards
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None