Multi Center Clinical Trials Conducted

(as a Principal Investigator & Co-Investigator)- 39 (Thirty-Nine)

International Trial-As a PI-No- 14 (Fourteen)
International Trial-As a Co-PI-No-9 (Nine)
National Trial-As a PI-No- 14 (Fourteen)
National Trial-As a Co-PI-No-2 (Two)

International Multicenter Clinical Trial-Principal Investigator:-

Protocol No. NN7533-4470 (Phase -III)- Protocol Title: A multicentre trial evaluating the efficacy and safety of oral decitabine tetrahydrouridine (NDec) in patients with sickle cell disease (ASCENT 1). Date of Initiation-2024.
Protocol No: CVAY736Q12301 -Protocol Title: “A phase 3 randomized, double-blind study of Ianalumab (VAY736) versus placebo in addition to Eltrombopag in patients with primary immune thrombocytopenia (ITP) who had an insufficient response or relapsed after first line steroid treatment (VAYHIT2)”. Date of initiation-2023.
Protocol Number: PZN-128 (Phase III)- Protocol Title: A randomized, international, multicenter double-blind study to compare the efficacy, safety, and immunogenicity of PZN-128 powder for solution for subcutaneous injection 250 µg (Pharmasyntez Nord JSC, Russia) versus comparator drug in patients with chronic idiopathic (immune) thrombocytopenic purpura. Date of Initiation-2023.
Protocol No.: CSEG101AIN01 (Phase IV)-Protocol Title: Burden of Vaso-Occlusive pain crisis: A Cross-sectional observational study among patients with sickle cell disease in India. Date of Initiation-2022.
Protocol Number: 209628/ 00- Protocol Title: A Phase 2, Randomized, Parallel, Open-Label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Various Dosing Regimens of Single-Agent Belantamab Mafodotin (GSK2857916) in Participants with Relapsed or Refractory Multiple Myeloma (DREAMM-14). Date of Initiation-2022.
Tittle of Trial: A Phase 3 Randomized Double-Blind Placebo-Controlled Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients with Lower Risk Myelodysplastic Syndrome (MDS) with Low Red Blood Cell (RBC) Transfusion Burden (LTB). Protocol No:- FGCL-4592-082. Date of Initiation-2022.
Protocol No- CSEG101A2403-Protocol Title: An Indian Multi-centric Phase IV study to assess the safety of Crizanlizumab with or without hydroxyurea therapy in sickle cell disease patients with vaso-occlusive crises. Date of Initiation-2021.
Tittle of Trial: A Randomized Open-Label, Phase 3 Study to Evaluate Imetelstat (GRN163L) Versus Best Available Therapy (BAT) in Patients with Intermediate-2 or High-risk Myelofibrosis (MF) Refractory/Relapse to Janus Kinase (JAK)-Inhibitor Protocol No:- GRN163LMYF3001. Date of Initiation-2021.
Protocol no-CARFILNAT-1 (Phase IV)-Protocol Title: -A open-label, multicenter, Phase IV Clinical Trial to evaluate disease response of Carfilzomib Injection with patients relapsed or refractory multiple myeloma who have received one to three lines of therapy. Date of Initiation-2020.
Protocol No: CMBG453B12301 Study (Phase-III) Title: A randomized, double-blind, placebo-controlled phase III multi-center study of azacitidine with or without MBG453 for the treatment of patients with intermediate, high or very high-risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2). Date of Initiation-2020.
KCP-330-023- A phase 2b Randomized, Controlled, Open label study of Selinexor, Bortezomib and Dexamethasone (SVD) versus Bortezomib and Dexamethasone (Vd) in patients with Relapsed or Refractory Multiple Myeloma (RRMM). Date of Initiation-2017.
KCP-330-009- A phase 2b Open label study of Selinexor, in patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL). Date of Initiation-2017.
Protocol: AB10004 (Phase III): -A multicenter, randomized, open-label, three-parallel groups, phase 2-3 study to evaluate the efficacy and safety of masitinib with dexamethasone, gemcitabine with dexamethasone and the combination of masitinib, gemcitabine and dexamethasone in patients with relapsed or refractory peripheral T-cell lymphoma. Date of Initiation-2016.
Protocol (Phase III). A multi-center open lable randomised study of BCD-020 (rituximab, CJSC BIOCAD, Russia) efficacy and safety in comparison with MabThara/ ristova (FF.Hoffmann-La Roche Ltd., Switzerland) in monotherapy of CD20-positive indolent non-Hodgkin lymphoma. Date of Initiation-2012.

International Multicenter Clinical Trial- Co-Principal Investigator:-

Protocol No.: CC-220-MM-002 -Protocol Title: “A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing Iberdomide, Daratumumab and Dexamethasone (Iberdd) Versus Daratumumab, Bortezomib, And Dexamethasone (Dvd) In Subjects with Relapsed or Refractory Multiple Myeloma (Rrmm) (Excaliber-Rrmm)”. PI-Dr Rajib De. Date of Initiation-2024.
A Phase II, Multicenter, open-label study to assess appropriate dosing and to evaluate safety of crizanlizumab,with or without hydroxyurea/hydroxycarbamide, in sequential, descending age groups of pediatric sickle cell disease patients with vaso-occlusive crisis. PI-Dr Rajib De. Date of Initiation-2023.
Protocol No.: 261203-Protocol Title: Phase 3, prospective, multi-center, open label study to investigate safety, immunogenicity, and hemostatic efficacy of PEGylated Factor VIII (BAX 855) in previously untreated patients (PUPs) < 6 years with severe hemophilia A (FVIII < 1%). PI-Dr Prakas Kumar Mandal. Date of Initiation-2020.
A Phase III randomised, double-blind, multicentre study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between sb12 (proposed eculizumab biosimilar) and ® Soliris in subjects with paroxysmal nocturnal haemoglobinuria. PI-Dr Prakas Kumar Mandal. Date of Initiation-2018.
A multicenter phase II open-label, single-arm, prospective, interventional study of plasma ® derived factor VIII/VWF (Alphanate ) in immune tolerance induction therapy in subjects with congenital Hemophilia A with inhibitors. . PI-Dr Prakas Kumar Mandal. Date of Initiation-2018.
A Single-Arm, Multicenter Phase IIIB Clinical Trial to evaluate the Safety and tolerability of prophylactic Emicizumab in Hemophilia A patients with Inhibitors. PI-Dr Prakas Kumar Mandal. Date of Initiation-2018.
ProtocolNo.:091501-Protocol Title: A Phase 3, Prospective, Multicenter, Open-label, Randomized, Crossover Study of Tolerability and Safety of FEIBA Reconstituted in Regular or 50% Reduced Volume and of Faster Infusion Rates in Patients with Hemophilia A or B with Inhibitors. PI-Dr Prakas Kumar Mandal. Date of Initiation-2018.
Protocol Number: B 3281006 (Phase-III) -Protocol Title: A Phase 3, Randomized, Double-blind study of PF-05280586 Versus Rituximab for the First-line Treatment of Patients with CD20-Positive, Low Tumour Burden, Follicular Lymphoma. PI-Dr Prantar Chakraborti; Date of Initiation-2014.
A Randomized, Double-Blind, Phase III Study Comparing Biosimilar Rituximab (RTXM83) Plus CHOP Chemotherapy Versus a Reference Rituximab Plus CHOP (R-CHOP) in Patients with Diffuse Large B-Cell Lymphoma (DLBCL) Given as First Line. Date of Initiation- 2013.

National Multicenter Clinical Trial- Principal Investigator:-

Protocol Number: HT-6184-MDS-001 (IIA). Protocol Title: Phase 2a study of HT-6184 in subjects with IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndrome (MDS) and Symptomatic Anemia. Date of Initiation-2024.
Protocol No.: LGD-NUV001-CT01-22 (Phase IV). Protocol Title: “A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate Safety and Efficacy of Orally administered NUV001 nutraceutical supplement in SCD patients. Date of Initiation-2024.
Protocol Number: C25030 (III). Protocol Title: A Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Safety and Efficacy of Brentuximab Vedotin plus Doxorubicin, Vinblastine, and Dacarbazine in Indian Patients with Untreated Stage 3/4 Classical Hodgkin Lymphoma. Date of Initiation-2024.
Protocol Number: CA056-023 (Phase IV). Protocol Title: A Phase 4 Study to Evaluate Safety and Effectiveness of Luspatercept (ACE-536) for the Treatment of Anemia due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic SyndromeS (MDS) with Ring Sideroblasts Who Require Red Blood Cell Transfusions in Subjects Who Have Had Unsatisfactory Response to or Are Ineligible to Erythropoietin Based Therapy and in Subjects With Transfusion Dependent Anemia Due to Beta-Thalassemia. Date of Initiation-2023.
Protocol Number: 0330-22Protocol (BA/BE). Title: A Randomized, Open-Label, Three-Treatment, Three-Arm, Three-Period, Single-Dose, Multi-Center, Cross-over Study to Assess Bioequivalence of Azacitidine Tablets of Intas Pharmaceuticals Ltd., India compared with ONUREG™ under Fasting Condition in Patients with Acute Myeloid Leukaemia in Remission Phase. Date of Initiation-2023.
Protocol Number: 0122-22 (III). Protocol Title: A Prospective, Nonrandomized, Open Label, Single Arm, Multicenter, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Human Normal Immunoglobulin for Intravenous Administration in Adult Patients with Chronic Primary Immune Thrombocytopenia. Date of Initiation-2023.
Protocol No.: PF-114-02(Phase III). Protocol Title: “A multicenter, open-label, randomized, phase III clinical trial to evaluate efficacy and safety of PF-114 versus imatinib at 600 or 800 mg daily in adult patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase (CP) resistant to imatinib at daily doses of 400 or 600 mg. Date of Initiation-2022.
Protocol Number: 484 (Phase IV)-14Protocol Title: Safety and efficacy study of Azadine® (Azacitidine) in treatment of myelodysplastic syndrome in Indian patients. Date of Initiation-2021.
Protocol Number: 063-15 (Phase III). Protocol Title: – A prospective, Open label, Multi-centric Study to evaluate the Efficacy and Safety of Inj. Romiplostim of Intas Pharmaceuticals Ltd. In Adult Indian Patients with Chronic Refractory Idiopathic Thrombocytopenic Purpura. Date of Initiation-2021.
Protocol Number: 0470-19 (IV). Protocol Title: A prospective, single-arm, multicentre study to assess safety and efficacy of Romy® (Romiplostim Powder for Injection) (Intas Pharmaceuticals Ltd., India) in patients with chronic refractory immune (idiopathic) thrombocytopenia purpura (ITP). Date of Initiation-2021.
Protocol #: RITU.17.001.01 (Phase III). Protocol Entitled: Randomized, Assessor-Blind, Multicentre, Parallel Group, Two Arms, Clinical Study to Assess the Efficacy, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety of Rituximab (Test Product, Zydus) in comparison with Rituximab (Reference Product, Roche/Genentech) in Patients with Diffuse Large B Cell Lymphoma (DLBCL). Date of Initiation-2018.
Protocol Number: 1005-16 (Phase IIIB)-Protocol Title: – A Prospective, Assessor-blind, Randomized, Parallel group Clinical Trial to Assess Single Dose Pharmacokinetics and Pharmacodynamics of Inj. Romiplostim from Intas Pharmaceuticals Ltd. and Inj. Romiplostim of Amgen Inc. (US licensed) in Patients with Chronic Refractory Immune (Idiopathic)Thrombocytopenic Purpura. Date of Initiation-2015.
Protocol (Phase III). A prospective, Open label, Multi-centric Study to evaluate the Efficacy and Safety of Inj. Romiplostim of Intas Pharmaceuticals Ltd. In Adult Indian Patients with Chronic Refractory Idiopathic Thrombocytopenic Purpura. Date of Initiation-2014.
Protocol Title (Phase III)-A Randomized, Multiple-dose, Multicenter, Comparative Parallel Study to Evaluate the Efficacy, Safety and Pharmacokinetic Characteristics of Intravenous Infusion Of Rituximab (Hetero) And Reference Medicinal Product (Rituximab, Roche) In Indian Patients Of Non-Hodgkins Lymphoma (HERILY Study). Date of Initiation-2013.

National Multicenter Clinical Trial-Co-Principal Investigator

Protocol Number:251602 (Phase IV)-study title: phase iv multi-center, prospective,interventional, post-marketing study in hemophilia b patients in india receiving rixubis as on-demand or prophylaxis under standard clinical practice. PI-Dr Prakas Kumar Mandal. Date of Initiation-2020.
CT/31/01/12 (Phase III)-An open label, single arm, multicentric study evaluating the safety and efficacy of intranasal methylcobalamin for treatment and maintenance therapy of vitamin B12 deficiency. PI-Dr Prantar Chakraborti. Date of Initiation-2015.