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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…

Skeletal complications of prophylactic ciprofloxacin in the treatment of pediatric ALL

To determine the musculoskeletal safety of standard prophylactic treatment with ciprofloxacin and co-administered glucocorticoids in pediatric patients with ALL.

A Phase 1 Trial to Assess the Mass Balance, Absolute Bioavailability, and Pharmacokinetics of 14C ASTX660 in Healthy Volunteers

The purpose of this study is to investigate how safe the new compound ASTX660 is and how well it is tolerated when it is administered to healthy volunteers. ASTX660 has been administered to humans before. It has also been previously tested in the…

A phase 1, open-label, randomized, 2-period, 2-sequence, crossover study to evaluate the bioequivalence of Bosutinib pediatric capsule and the commercial tablet formulations in healthy participants under fed condition

The purpose of this study is to investigate how quickly and to what extent bosutinib is absorbed and eliminated from the body (this is called pharmacokinetics). The pharmacokinetics of bosutinib administered as a capsule will be compared to the…

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…

A Prospective, Open-Label, Single-Arm, Phase 2, Multicenter Study Evaluating the Efficacy of
Venetoclax Plus Ibrutinib in Subjects with T-Cell Prolymphocytic Leukemia

The primary objective is to demonstrate the efficacy in subjects with R/R T-PLL treated with venetoclax plus ibrutinib.

AN OPEN-LABEL BOSUTINIB TREATMENT EXTENSION STUDY FOR SUBJECTS WITH CHRONIC MYELOID LEUKEMIA (CML) WHO HAVE PREVIOUSLY PARTICIPATED IN BOSUTINIB STUDIES B1871006 OR B1871008

The objectives of the current study are:1. To allow long term bosutinib treatment in patients with chronic or advanced phases of Ph+ CML who received bosutinib in a previous Pfizer sponsored CML study (i.e., studies B1871006 and B1871008) and who…

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PHASE III STUDY OF IDASANUTLIN, AN MDM2 ANTAGONIST, WITH CYTARABINE VERSUS CYTARABINE PLUS PLACEBO IN PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML).

The primary objective for this study is as follows:Within the TP53 wild-type populationTo compare overall survival (OS) in patients with relapsed or refractory AML who havebeen randomized to idasanutlin in combination with cytarabine versus those…

A phase II trial in patients with myelofibrosis (primary, post-ET or post PV-MF) treated with the selective JAK2 inhibitor Pacritinib before reduced-intensity conditioning allogeneic stem cell transplantation

Improve allo-SCT transplant outcome using a uniform conditioning regimen and pacritinib pretreatment by means of the proportion of patients with a failure within 6 months post-transplant. Events that are considered a failure are: primary graft…

A multi-center, open label, non-controlled phase II study to evaluate efficacy and safety of oral nilotinib in pediatric patients with newly diagnosed Ph+ chronic myelogenous leukemia (CML) in chronic phase (CP) or with Ph+ CML in CP or accelerated phase (AP) resistant or intolerant to either imatinib or dasatinib

Primary objectives:* To assess efficacy of nilotinib in pediatric patients with Ph+ CML CPresistant or intolerant to either imatinib or dasatinib.* To assess efficacy of nilotinib in pediatric patients with Ph+ CML APresistant or intolerant to…

Vincristine-induced peripheral neuropathy in children with childhood cancer: comparing one-hour infusions with short-term infusions (the VINCA-study)

This study aims to investigate whether the administration of VCR in children with acute lymphoblastic leukemia, nephroblastoma, low-grade glioma, Hodgkin lymphoma and rhabdomyosarcoma by one-hour infusions, resulting in lower peak plasma…

A Phase II Study of Dasatinib Therapy in Children and Adolescents with Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia or with Ph+ Leukaemias Resistant or Intolerant to Imatinib

The main objective of this study is to estimate the rate of response to dasatinib in children and adolescents with certain types of Ph+ leukaemia either whose disease is resistant to, intolerant to or relapsed after previous imatinib therapy or are…

An open label, multi-center nilotinib roll-over protocol for patients who have completed a previous Novartis-sponsored nilotinib study and are judged by the investigator to benefit from continued nilotinib treatment

The purpose of this study is to allow continued use of nilotinib in patients who are on nilotinib treatment in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study and are benefiting from the treatment…

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…

A Phase 1/2, open-label, single arm, multicohort, multicenter trial to evaluate the safety and efficacy of JCAR017 in pediatric subjects with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin lymphoma (B-NHL) (TRANSCEND PEDALL)

Phase 1:To identify the recommended Phase 2 dose (RP2D) of JCAR017 in pediatric subjects withCD19+ r/r B-ALL.Phase 2:To evaluate the following efficacy endpoints of the JCAR017 RP2D identified in Phase 1, in the following three diseasecohorts:•…

Allogeneic Stem Cell Transplantation (SCT) for children and adolescents with acute lymphoblastic Leukaemia (ALL)

This study has been transitioned to CTIS with ID 2024-512657-24-00 check the CTIS register for the current data. Stratum 1:To show that a non total body irradiation (TBI) containing conditioning (Flu/Thio/ivBu) results in a non inferior survival as…

Phase 1b/2 Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia

The Primary Objectives of the Phase 1b are: • To assess the safety and tolerability of carfilzomib, alone and in combination with induction chemotherapy, for the treatment of children with relapsed or refractory ALL • To determine the maximum…

A Phase II randomized multicenter study to assess the efficacy of lenalidomide with or without erythropoietin and granulocyte-colony stimulating factor in patients with low and intermediate-1 risk myelodysplastic syndrome

Primary objective- To evaluate the efficacy of lenalidomide (RevlimidTM) in low/int-1 risk MDS with or without a treatment with Epo (NeoRecormonTM)/G-CSF (NeupogenTM) in terms of hematological improvement (HI) as defined by the modified response…

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…