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An international, multicentre, open-label study to evaluate the efficacy and safety of two different vaccination regimens of immunotherapy with allogeneic dendritic cells, DCP-001, in patients with acute myeloid leukemia that are in remission with persistent MRD.

Primary:• To assess the effect of DCP-001 on MRD. MRD will be measured by flow cytometry pre and post vaccination as a surrogate marker for established clinical endpoints in AML.• To assess the effect of DCP-001 on immune responses in AML patients…

European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors (ESMART)

This study has been transitioned to CTIS with ID 2024-514791-40-00 check the CTIS register for the current data. Based on results from a comparative review (Paoletti 2013), we hypothesize that if the toxicity profile and the PK parameters observed…

A phase 3, multi-center, open-label, randomized study of oral ABL001 versus bosutinib in patients with Chronic Myelogenous Leukemia in chronic phase (CML-CP), previously treated with 2 or more tyrosine kinase inhibitors (CABL001A2301)

Primary: To compare the Major Molecular Response (MMR) rate at 24 weeks of ABL001 versus bosutinibSecondary: To compare additional parameters of the efficacy of ABL001 versus bosutinib. Safety, tolerability.

NAUT study: Multicenter prospective trial after first or second unsuccessful treatment discontinuation in chronic myeloid leukemia estimating the efficacy of nilotinib in inducing the persistence of molecular remission after stopping TKI 2nd time or 3rd time

Assessment of duration of MMR or better after stopping TKI therapy a second or third time in patients with at least three years prior TKI treatment comprising at least two years of nilotinib treatment and maintained stable MR4 for at least one year…

A Phase 1 Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients with Relapsed or Refractory Malignancies

The main objectives of the trial are to:• evaluate the safety of venetoclax monotherapy.• determine dose limiting toxicities (DLT) and the recommended Phase 2 dose (RPTD) of venetoclax monotherapy.• assess the pharmacokinetics (PK) of venetoclax…

Dipeptidylpeptidase IV (CD26) on Philadelphia-positive leukemic stem cells (LSC) as marker and novel therapeutic target in chronic myeloid leukemia (CML).

The purpose of this study is to determine the safety and efficacy of Nilotinib and Vildagliptin as combination therapy in optimal dosage. In addition, it is investigated whether the addition of Vildagliptin to Nilotinib treatment causes the…

A Multicenter Phase 1, Open-Label Study of DCC-2618 to Assess Safety, Tolerability, Efficacy, and Pharmacokinetics in Patients with Advanced Malignancies

Escalation PhasePrimary ObjectivesThe primary objectives of this study are to:• Determine the safety and tolerability of oral DCC-2618• Determine a maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of oral DCC-261Secondary…

Phase 1b, multi-arm, open-label study of PDR001 and/or MBG453 in combination with decitabine in patients with acute myeloid leukemia or high risk myelodysplastic syndrome (CPDR001X2105)

Primary: To characterize the safety and tolerability of PDR001 and/or MBG453 in combination with decitabine or azacitidine in relapsed/refractory AML patients, de novo AML patients not candidates for standard induction therapy, or high risk or…

A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of AG-120 in Combination with Azacitidine in Subjects * 18 Years of Age with Previously Untreated Acute Myeloid Leukemia with an IDH1 Mutation

Primary Objective:* To compare event-free survival (EFS) between AG-120 + azacitidine and placebo + azacitidine. Key Secondary Objectives:* To compare the complete remission (CR) rate between AG-120 + azacitidine and placebo + azacitidine. EFS is…

A prospective, multicenter, phase-II trial of ibrutinib plus venetoclax in physically fit patients with creatinine clearance >= 30 ml/min who have relapsed or refractory chronic lymphocytic leukemia (RR-CLL) with or without TP53 aberrations;HOVON 141 CLL / VIsion Trial of the HOVON and Nordic CLL study groups

This study has been transitioned to CTIS with ID 2023-510557-42-00 check the CTIS register for the current data. The primary objective: - Evaluate efficacy of ibrutinib + venetoclax (VI) in terms of proportion of patients fulfilling the criteria for…

An Open Label Phase 1, First-In-Human Study of TRAIL Receptor Agonist ABBV-621 in Subjects with Previously-Treated Solid Tumors and Hematologic Malignancies

The primary objectives are to determine the maximum tolerated dose (MTD) and/or recommended phase two dose (RP2D) of ABBV-621 and to evaluate pharmacokinetics (PK) of (A) single agent ABBV-621; and (B) the combination of ABBV-621 and venetoclax in…

Blinatumomab added to prephase and consolidation therapy in precursor B-acute lymphoblastic leukemia in adults. A phase II trial.

This study has been transitioned to CTIS with ID 2024-511050-44-00 check the CTIS register for the current data. Primary objective:-To assess the proportion of patients that achieve MRD negative response (by PCR/FCM) after the first consolidation…

A pilot study to test the feasibility, safety and efficacy of the addition of the BiTE antibody Blinatumomab to the Interfant-06 backbone in infants with MLL-rearranged acute lymphoblastic leukemia. A collaborative study of the Interfant network.

The primary objective of the study is to assess the safety of 1 course of blinatumomab added to the Interfant-06 backbone in infants with newly diagnosed ALL. The secondary objectives are: • to assess the feasibility• to define the preliminary…

Diagnosing invasive fungal infections on DNA extracted from serum or plasma of immunocompromised patients with a suspected invasive pulmonary fungal infection

1. Optimise the DNA extraction process on serum and plasma to increase the sensitivity of DNA-based fungal infection diagnostic test (especially genetic mutations conferring azole resistance in invasive aspergillosis). 2. Evaluate new targeted as…

A Phase III, multicenter, randomized controlled study to compare safety and efficacy of a haploidentical HSCT and adjunctive treatment with ATIR101, a T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells, versus a haploidentical HSCT with post-transplant cyclophosphamide in patients with a hematologic malignancy (HATCY studie)

The objective of this study is to compare safety and efficacy of a haploidentical T cell depleted HSCT and adjunctive treatment with ATIR101 versus a haploidentical T cell replete HSCT with post-transplant administration of high dose…

A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB059872 in Subjects With Advanced Malignancies

Primary objectives:* Part 1: To evaluate the safety and tolerability and determine the recommended dose(s) of INCB059872 for further study in advancedmalignancies.* Part 2: To further evaluate the safety and tolerability of INCB059872 for further…

An Open Label, Dose-Finding and Proof of Concept Study of the PD-L1 Probody* Therapeutic, CX-072, as Monotherapy and in Combination with Yervoy® (Ipilimumab) or with Zelboraf® (Vemurafenib) in Subjects with Advanced or Recurrent Solid Tumors or Lymphomas

The primary objectives of the study are:For Parts A through C:1. Evaluate the safety and tolerability of multiple doses of CX-072, administered as monotherapy or in combination with ipilimumab or vemurafenib to patients with metastatic or locally…

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).

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…

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…