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Characterization of buffy-coat-derived granulocytes for clinical use: - identifying clinical and laboratory parameters for decision making

• To find surrogate markers in plasma in order to identify patients, which may benefit from granulocyte transfusions and which are at risk for transfusion complications.• To determine - in combination with the outcomes of the NEPTUNIS study -…

A Randomized, Double-blind, Active-controlled, Phase 3 study evaluating the Efficacy and Safety of ABP 959 compared with Eculizumab in Adult Subjects with Paroxysmal Nocturnal Hemoglobinuria (PNH)

Primary Objective: The primary objective for this study is to evaluate the efficacy of ABP 959 compared with that of eculizumab based on control of intravascular hemolysis.Secondary Objective: The secondary objective is to assess the safety,…

Multicenter randomized controlled trial comparing Ferric(III)carboxymaltose infusion with oral iron suppletion in the treatment of perioperative anemia in patients with a colorectal carcinoma.

The aim of this trial is to investigate which treatment option is superior in the treatment of anemia in patients undergoing surgery in terms of hemoglobin increase, postoperative morbidity, amount of bloodtransfusions needed, length of stay,…

A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with
Amyloid Light Chain (AL) Amyloidosis

This study has been transitioned to CTIS with ID 2023-507069-25-00 check the CTIS register for the current data. The primary objectives for the study are: Cohort 1, to characterize cardiac safety of different Daratumumab, cyclophosphamide,…

The pharmacokinetics and pharmacodynamics of eculizumab in patients with paroxysmal nocturnal hemoglobinuria.

To describe the real-world population pharmacokinetics and pharmacodynamics of eculizumab in unselected PNH patients

A phase 3b, prospective, open-label, uncontrolled, multicenter study on long-term safety and efficacy of rVWF in pediatric and adult subjects with severe von Willebrand disease (VWD)

To evaluate the efficacy of rVWF (vonicog alfa) prophylaxis based on the annualized bleeding rate (ABR) of spontaneous (not related to trauma) bleeding episodes in adult and pediatric / adolescent subjects (aged 12 to <18 years) during the…

A Phase 2 Proof-of-Concept Study to Separately Evaluate the Activity of Talacotuzumab;(JNJ-56022473) or Daratumumab in Transfusion-Dependent Subjects with Low or;Intermediate-1 Risk Myelodysplastic Syndromes (MDS) who are Relapsed or Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment

The purpose of this study is to separately evaluate 2 agents with different mechanisms of action that may be effective in subjects with low-risker MDS. The design of this study will allow an unbiased assessment of which agent, if either, will…

A Phase 1/2 Study of CPI-0610, a Small Molecule Inhibitor of BET Proteins: Phase 1 (Dose Escalation of CPI-0610 in Patients with Hematological Malignancies) and Phase 2 (Dose Expansion of CPI-0610 with and without Ruxolitinib in Patients with Myeloproliferative Neoplasms)

Phase 2 (MF Expansion-Prior JAKi Arm 1 and Add-on to JAKi Arm 2) Primary Objectives:- To evaluate splenic response rate by imaging after 24 weeks of treatment in Cohorts 1B and 2B (i.e., in non-TD cohorts)- To evaluate the rate of conversion from…

A randomized, open-label, phase I/II open platform study evaluating safety and efficacy of novel ruxolitinib combinations in myelofibrosis patients

To characterize the safety, tolerability, and recommended phase 2 dose (RP2D) of each combination partner used with ruxolitinib (Part 1)To evaluate the preliminary efficacy of each novel ruxolitinib combination treatment arm (Parts 2 & 3)

An Open-Label, Multicenter, Phase 1/2 Trial of GEN3014 (HexaBody®-CD38) in Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies

Dose escalation phase:Primary• Determine the RP2D and if reached, the MTD of GEN3014• Evaluate the safety and tolerability of GEN3014 Secondary:• Characterize the PK properties of GEN3014• Characterize the pharmacodynamic properties of GEN3014•…

Long Term Follow Up Study for Participants of Kite Sponsored Interventional Studies Treated with Gene Modified Cells

This study has been transitioned to CTIS with ID 2023-507041-28-00 check the CTIS register for the current data. The primary objectives of this study are to:• Evaluate the incidence and severity of late-onset targeted adverse events (AEs)/serious…

Leukapheresis of healthy volunteer donors for T cell study and TolDC production process validations

To obtain fresh mononuclear cells from healthy volunteer donors to be used for validation of procedures for the generation of GMP-grade T cell or tolerogenic dendritic cell products for clinical application.

An Open-label, Single Arm, Phase 2 Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, in Patients with Advanced Systemic Mastocytosis

Primary: • The primary objective is to determine adjudicated ORR (CR/CR with partial recovery of peripheral blood counts [CRh] + PR + CI) based on modified IWG-MRT-ECNM consensus response criteria in patients with AdvSM treated with avapritinib and…

Cross-tumoral Phase 2 clinical trial exploring Crizotinib (PF-02341066) in patients with advanced tumours induced by causal alterations of either ALK or MET.

Primary objective* To study the antitumor activity and safety of crizotinib across predefined tumor types in patients whose tumors are harboring specific alterations in ALK and/or METSecondary objectives* To study the specificity of the kinase…

Immune monitoring after anti-CD19 CAR T-cel therapy with patients with B-cell NHL

To determine the factors that contribute to response to CAR T-cell therapy, both at the tumour-end, as well as on the T-cell side to understand mechanisms of efficacy and immune escape in order to optimize this treatment and to reduce toxicity

A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects with Previously Untreated Multiple Myeloma who are Ineligible for High Dose Therapy

The primary objective is to compare the efficacy of daratumumab when combined with lenalidomide and dexamethasone (DRd) to that of lenalidomide and dexamethasone (Rd), in terms of progression-free survival (PFS) in subjects with newly diagnosed…

A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

The primary objective of this study is:- To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA)The secondary objectives of this study are:-To compare the proportion of subjects with wAIHA…

The BITE study - Bleeding In Thrombocytopenia Explained: A nationwide epidemiological and laboratory case cohort study investigating risk factors for bleeding in hemato-oncology patients

- Identify hemato-oncology patients and conditions with a high versus a low bleeding risk, by epidemiological research and a short questionnaire. - Investigate the association of bleeding related biomarkers with bleeding.

Searching Patterns In the Robustness of Immunological FVIII Tolerance

The aim of SPIRIT is to investigate the mechanisms of the immunological tolerance to FVIII in patients with hemophilia A aged younger than 18 years using NFT for prophylaxis.

SARS-CoV-2 vaccination response in patients with haematological
disease

3.2.1 Primary objectivesTo assess the efficacy in terms of Anti-SARS-COV-2 RBD antibody responses in patients diagnosed with and/or under treatment for a hematological disorder to SARS-CoV-2 vaccination.3.2.2 Secondary objectives 1. What is the…