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Prospective Analysis of an individualized dosing Regimen of ATG (Thymoglobulin) in Children Undergoing HCT: redUcing Toxicity and improving Efficacy * a single arm phase II study

To investigate whether an individualized dosing regimen for Thymoglobulin leads to a better immune reconstitution after HCT (definition as in primary endpoint), as compared to historically non-individualized treated patients receiving Thymoglobulin…

A phase I/II study of Inotuzumab Ozogamicin as a single agent and in combination with chemotherapy for pediatric CD22-positive relapsed/refractory Acute Lymphoblastic Leukemia
Study ITCC-059

This study has been transitioned to CTIS with ID 2023-504694-20-00 check the CTIS register for the current data. - The primary objective of the Stratum 1A cohort is to establish the maximum tolerated dose of single agent InO when administered in…

A phase III multi-center, open label, randomised study of optimised imatinib versus nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP)

Primary* To compare the efficacy (Major Molecular Response, MMR, rate at 12 months) Secondary* To compare the rate of durable MMR at 24 months in patients with a MMR at 12 months* To compare the rate, time to and duration of complete cytogenetic…

A Phase 3 Open-Label Randomized Study of Quizartinib (AC220) Monotherapy Versus Salvage Chemotherapy in Subjects with FLT3-ITD Positive Acute Myeloid Leukemia (AML) Refractory To or Relapsed After First-line Treatment With or Without Hematopoietic Stem Cell Transplantation(HSCT) Consolidation.

Quizartinib selectively inhibits survival pathways that block apoptosis by inhibiting FLT3. Quizartinib inhibits proliferation of FLT3-dependent cell lines, and is effective in human leukemia tumor xenograft models of AML. Data from the Phase 1 and…

A randomized, double-blindphase 3 study of vadastuximab talirine (SGN-CD33A)versus placebo in combination with azacitidine or decitabine in the treatment of older patients with newly diagnosed acute myeloid leukemia (AML)

Primary* To compare the composite complete remission (CRc) rate (morphologic complete remission [CR] and morphologic CR with incomplete hematologic recovery [CRi]) between treatment arms * To compare overall survival (OS) between treatment…

The changing over time of ascorbic acid after chemotherapy and the correlation between ascorbic acid and the recovery of the immune cells after chemotherapy in patients receiving intensive clinical chemotherapy for acute leukemia and high dose chemotherapy with autologous stem cell rescue and in outpatients receiving relatively mild chemotherapy for lung cancer and colon cancer.

The aim of this study is to evaluate the changing over time of AA levels in plasma and in leukocytes before and during chemotherapy treatment for several different groups of patients and compare that to healthy controls.

A randomized Phase III study to compare arsenic trioxide (ATO) combined to ATRA and idarubicin versus standard ATRA and anthracycLines-based chemotherapy (AIDA regimen) for patients with newly diagnosed, high-risk acute prOmyelocytic leukemia.

To compare event-free survival (EFS) of the experimental treatment arm including ATO/ATRA and idarubicin with standard treatment based on ATRA plus chemotherapy (AIDA regimen).

International randomized phase III study on the treatment of children and adolescents with refractory or relapsed acute myeloid leukemia

The main objective of this treatment protocol is to study the efficacy on the treatment response after adding a single gift of Mylotarg. Furthermore, monitoring of toxicity and long term efficacy is also important.

Distribution of NIlotinib in semen in men treated for chronic Myeloid leukaemiA

This study is designed to determine the level of nilotinib detectable in seminal fluid of men treated with this tyrosine kinase inhibitor and in order to form an advise on the use of physical barriers like, condoms, to protect sexual partners from…

An Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Subjects >=1 and <=30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

The primary objective is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) and T-cell ALL as measured by the complete response (CR) rate.The secondary…

Evaluation of the intracellular pharmacokinetics of decitabine in patients with leukemia or myelodysplasia

The present study will be focused on exploring the intracellular pharmacokinetics of decitabine

PERSISTENCE OF MAJOR MOLECULAR REMISSION IN CHRONIC MYELOID
LEUKEMIA AFTER a second stop of TKI TREATMENT in patients who failed an
initial stop attempt : a multicenter prospective trial

Assessment of treatment-free remission (persistence of MMR) after second attempt of TKI discontinuation in patients who failed a relapsed in the EURO-SKI study or under EURO-SKI like conditions. Patients must have received at least three years of…

A Phase 2, Randomized, Controlled, Open-Label, Clinical Study of the Efficacy and Safety of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, and Low-Blast Acute Myelogenous Leukemia

Primary• To determine in patients with higher-risk myelodysplastic syndrome (HR MDS), chronic myelomonocytic leukemia (CMML), and low-blast acute myelogenous leukemia (AML) whether the combination of pevonedistat and azacitidine improves event-free…

A phase I/II trial towards the safety and efficacy of preemptive vaccination with PD-L silenced, minor histocompatibility antigen UTA2-1 peptide-loaded Dendritic Cells after Allogeneic Stem Cell Transplantation

- To evaluate the toxicity and feasibility of a preemptive minor H ag UTA2-1 peptide-loaded, PD-L silenced donor DCvaccination.- To evaluate the effect of a minor H ag UTA2-1 peptide-loaded, PD-L silenced donor DC vaccination on the immunestatus of…

A Phase 3, Multicenter, Open-label, Randomized Study of SGI-110 versus Treatment Choice (TC) in
Adults with Previously Untreated Acute Myeloid Leukemia (AML) Who Are Not Considered Candidates for Intensive Remission Induction Chemotherapy

To assess and compare efficacy (complete response [CR] rate and overall survival [OS]) between SGI-110 and TC in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy.

Cognitive Bias Modification: Exploring the effects of a computer-based cognitive bias training in patients with acute myeloid leukemia at risk for depression and anxiety symptoms -(HemaCogTrain)

The purpose of our exploratory study is to test the effect of a computer-based cognitive behavioural intervention (called Cognitive Bias Modification, CBM) on affective symptoms in patients with AML during their stay at the hospital.

Long-term follow-up of patients previously treated with autologous T cells genetically modified with retroviral vectors.

Primary Objective:- Long-term safetySecondary Objective:- Survival- Clinical efficacy of AUTO CAR T cell therapy in patients enrolled prior to disease progression- Chimeric antigen receptor (CAR) transgene persistence- Replication competent…

A Phase 1 Trial to Assess the Mass Balance and Pharmacokinetics of 14C-Guadecitabine in Subjects with AML, MDS, or Solid Tumors

This study will provide an estimate of basic PK parameters for guadecitabine, an assessment of the routes and rates of elimination of radioactivity, and identification of metabolites and metabolic pathways.

A phase I, open label, multicenter, dose-escalation study of oral HDM201 in adult patients with advanced solid and hematological tumors characterized by wild-type TP53

Primary objective To determine the MTD and/or to identify the RDE of HDM201 in one or more of the pre-defined regimensSecondary objectives * To characterize the safety and tolerability of HDM201* To characterize the pharmacokinetic (PK) properties…