Yeni Tanı Konulmuş Multipl Miyelom (NDMM) Hastalarında Otolog Kök Hücre Naklinden (ASCT) Sonra İberdomid’e İdame ile Lenalidomid İdame Tedavisini Karşılaştıran Faz 3, İki Aşamalı, Randomize, Çok Merkezli, Kontrollü, Açık Etiketli Bir Çalışma
18.03.2025 – SİNAN MERSİN
Relaps veya Refrakter Diffüz Büyük B Hücreli Lenfomalı Katılımcılarda Epkoritamab artı Lenalidomidin Rituksimab artı Gemsitabin ve Oksaliplatin ile Karşılaştırıldığı Faz 3, Çok Merkezli, Randomize, Açık Etiketli Çalışma
14.03.2025 – SİNAN MERSİN
Relaps veya Refrakter Multipl Miyelomlu Çalışma Katılımcılarında Etentamig’in Standart Mevcut Tedavilerle Karşılaştırıldığı Faz 3, Çok Merkezli, Randomize, Açık Etiketli Çalışma (3L+ RRMM Monoterapi Çalışması)
10.03.2025 – SİNAN MERSİN
MAGNETISMM-5 / Lenalidomid Ve Proteazom İnhibitörü İçeren En Az 1 Basamak Tedavi Almış Relaps/Refrakter Multipl Miyelom Hastalığı Olan Gönüllülerde Elranatamab (PF-06863135) Monoterapisi Ve Elranatamab + Daratumumaba Kıyasla Daratumumab + Pomalidomid + Deksametazonun Etkililiğinin Ve Güvenliliğinin Değerlendirildiği Açık Etiketli, 3 Kollu, Çok Merkezli, Randomize Faz 3 Çalışma
18.12.2024 – SİNAN MERSİN
Relaps ve/veya refrakter multipl miyelom (RRMM) tanılı yetişkin gönüllülerde pomalidomid, deksametazon ile kombine tedavide subkutan isatuksimaba karşı intravenöz isatuksimab tedavisinin değerlendirildiği, randomize, Faz 3, açık etiketli bir çalışma
14.10.2024 – SİNAN MERSİN
Yeni Tanı Konmuş Multipl Miyelomlu Hastalarda Otolog Kök Hücre Transplantasyonunun Ardından İdame Tedavisi Olarak Lenalidomid ile Kombinasyon Halinde Teklistamab ve Tek Başına Lenalidomide Karşı Tek Başına Teklistamabın karşılaştırıldığı Faz 3 Çalışma (MajesTEC-4)
14.10.2024 – SİNAN MERSİN
Compare the Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in LTB Follicular Lymphoma (FLINTER)
The primary objective of the current study is to demonstrate the equivalent efficacy of rituximab (DRL_RI) and MabThera® in subjects with Low Tumor Burden Follicular Lymphoma (LTB-FL). Also evaluated by Pharmacokinetic, safety, and immunogenicity assessment between a proposed biosimilar (DRL_RI) and the RMP, as an component of clinical study program, and collectively providing the evidence of biosimilarity. The study will compare the safety and efficacy of DRL_RI vs MabThera in patients with Low Tumor Burden Follicular Lymphoma (LTB-FL). The primary objective is to establish comparative efficacy as measured by ORR at week 28
23.10.2019 – PINAR TARKUN, ÖZGÜR MEHTAP, ÖZGÜR ÇAKIR, AYFER GEDÜK, SİNAN MERSİN, KEMAL AYGÜN, MERVE GÖKÇEN POLAT
A Phase II, Open-label, Prospective, Single-arm, Study to Assess Ability of Eltrombopag to Induce Sustained Remission in Subjects With ITP Who Are Refractory or Relapsed After First-line Steroids (TAPER)
This study will assess the ability of eltrombopag to induce sustained treatment-free remission in ITP subjects who relapsed or failed to respond to an initial treatment with steroids. There is limited, mainly retrospective evidence that earlier use of eltrombopag after ITP diagnosis, will allow a larger proportion of subjects to achieve sustained remission after tapering off drug. Clinically there is a need for a less toxic regimen that will provide responses and sustained remission with a shorter treatment interval. This trial is designed to assess this.
29.11.2019 – 07.02.2023 PINAR TARKUN, AYFER GEDÜK, EMEL MERVE YENİHAYAT, MERVE GÖKÇEN POLAT, SİNAN MERSİN, KEMAL AYGÜN, SERKAN ÜNAL, ÖZGÜR MEHTAP, ABDULLAH HACİHANİFİOĞLU
AFM13-202 :A phase Open –label Multicenter Study to Access the Efficacy Safety of AFM13 in Patients with Relapsed or Refratory CD30-positive Peripheral T-cell Lymphoma or Transformed Mycosis Fungoides (REDIRECT)
This is a phase II study to evaluate the antitumor activity and safety of AFM13 given as monotherapy in patients with CD30-positive T-cell lymphoma. The investigational medicinal product AFM13 is a tetravalent bispecific chimeric (anti-human CD30 x anti-human CD16A) recombinant antibody construct which is being developed to treat CD30-positive malignancies.
19.11.2019 – 26.11.2021 ÖZGÜR MEHTAP, AYFER GEDÜK, SİNAN MERSİN, PINAR TARKUN, ÇİĞDEM VURAL, Görür Gözde Dağlıöz, ÖZGÜR ÇAKIR
A randomized, double-blind, placebo-controlled phase II multi-center study of intravenous MBG453 added to hypomethylating agents in adult subjects with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R criteria
This Phase II is a multicenter, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to hypomethylating agents (azacitidine or decitabine) in adult subjects with IPSS-R intermediate, high or very high risk myelodysplastic syndrome (MDS) not eligible for Hematopoietic Stem Cell Transplant (HSCT) or intensive chemotherapy.
23.09.2019 – 26.11.2021 PINAR TARKUN, AYFER GEDÜK, ÖZGÜR MEHTAP, SİNAN MERSİN, SERKAN ÜNAL, EMEL MERVE YENİHAYAT, MERVE GÖKÇEN POLAT, KEMAL AYGÜN, ABDULLAH HACİHANİFİOĞLU