Clinical trials
A ‘clinical trial’ is a research study in which people agree to test a potential new treatment to prevent or improve a disease or medical condition. A clinical trial also looks at how participants react to the potential new treatment and if any unwanted effects occur. This helps to determine if the new investigational treatment works, is safe, and is better than those that are already available. Many clinical trials also compare existing treatments or test new ways to use or combine existing treatments.
Clinical Trial of Debio 1562 in non-Hodgkin lymphoma
Debiopharm International is conducting an open-label Definition An open-label trial means that no placebo is administered and that patients know what treatment they are given. non-randomized two-part Phase II trial in male and female patients with diffuse large B cell lymphoma and other types of NHL.
The first part of this trial aims at evaluating the safety of Debio 1562 Definition Debio 1562 (IMGN529), an antibody-drug conjugate (anti-CD37 ADC), is a potential new treatment for patients with B-cell malignancies, such as non-Hodgkin lymphoma (NHL). Debio 1562 demonstrated evidence of anti-cancer activity in NHL in a Phase 1 monotherapy trial and successfully completed a safety lead-in study in combination with Rituxan®. The product is now ready to enter into expansion in NHL and particularly in relapsed/refractory diffuse large-cell B-cell lymphoma (R/R DLBCL) for which it benefits from Orphan Drug status. More info: http://bit.ly/2hDaqoi (Debio 1562 Definition Debio 1562 (IMGN529), an antibody-drug conjugate (anti-CD37 ADC), is a potential new treatment for patients with B-cell malignancies, such as non-Hodgkin lymphoma (NHL). Debio 1562 demonstrated evidence of anti-cancer activity in NHL in a Phase 1 monotherapy trial and successfully completed a safety lead-in study in combination with Rituxan®. The product is now ready to enter into expansion in NHL and particularly in relapsed/refractory diffuse large-cell B-cell lymphoma (R/R DLBCL) for which it benefits from Orphan Drug status. More info: http://bit.ly/2hDaqoi is an investigational medicine product) combined with rituximab Definition a drug already on the market for several of these diseases. in patients with diffuse large B cell lymphoma, follicular lymphoma, mantle cell lymphoma and marginal zone lymphoma/mucosa-associated lymphoid tissue. Debio 1562 Definition Debio 1562 (IMGN529), an antibody-drug conjugate (anti-CD37 ADC), is a potential new treatment for patients with B-cell malignancies, such as non-Hodgkin lymphoma (NHL). Debio 1562 demonstrated evidence of anti-cancer activity in NHL in a Phase 1 monotherapy trial and successfully completed a safety lead-in study in combination with Rituxan®. The product is now ready to enter into expansion in NHL and particularly in relapsed/refractory diffuse large-cell B-cell lymphoma (R/R DLBCL) for which it benefits from Orphan Drug status. More info: http://bit.ly/2hDaqoi has been well tolerated in a previous clinical trial.
The purpose of the second part of this trial, which is in the planning stage, is to evaluate the efficacy of Debio 1562 Definition Debio 1562 (IMGN529), an antibody-drug conjugate (anti-CD37 ADC), is a potential new treatment for patients with B-cell malignancies, such as non-Hodgkin lymphoma (NHL). Debio 1562 demonstrated evidence of anti-cancer activity in NHL in a Phase 1 monotherapy trial and successfully completed a safety lead-in study in combination with Rituxan®. The product is now ready to enter into expansion in NHL and particularly in relapsed/refractory diffuse large-cell B-cell lymphoma (R/R DLBCL) for which it benefits from Orphan Drug status. More info: http://bit.ly/2hDaqoi combined with rituximab Definition a drug already on the market for several of these diseases. in patients with diffuse large B cell lymphoma and other forms of NHL. Patients will be treated with Debio 1562 Definition Debio 1562 (IMGN529), an antibody-drug conjugate (anti-CD37 ADC), is a potential new treatment for patients with B-cell malignancies, such as non-Hodgkin lymphoma (NHL). Debio 1562 demonstrated evidence of anti-cancer activity in NHL in a Phase 1 monotherapy trial and successfully completed a safety lead-in study in combination with Rituxan®. The product is now ready to enter into expansion in NHL and particularly in relapsed/refractory diffuse large-cell B-cell lymphoma (R/R DLBCL) for which it benefits from Orphan Drug status. More info: http://bit.ly/2hDaqoi and rituximab Definition a drug already on the market for several of these diseases. by intravenous injection on the same day once every three weeks.
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Phases
When a potential new medication is being developed, it is first tested in a laboratory setting. If the results are positive, the drug may enter a clinical trial program. This means that it will be tested in humans in several ‘phases’ of study.
Phase I = Safety evaluation. The very first administration in humans, typically carried out in a small group of healthy volunteers to assess if the drug is safe.
Phase II = Efficacy evaluation. The first trials in patients with the intended disease to check if the drug works efficiently and if there are any unwanted side effects.
Phase III = Confirming findings. Trials in large numbers of patients that generally compare the drug to the best treatments available._Phases
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