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Number of records: 123
Title of the trial Diagnosis
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 Myelogenous Leukemia
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 Myeloid leukemia
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 Transplant (HSCT) Consolidation. Myeloid leukemia
A Phase 3, Multicenter, Open-label, Randomized Study Comparing the Efficacy and Safety of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects with Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation. Myeloid leukemia
International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010 acute lymphoblastic leukemia
A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton?s Tyrosine Kinase Inhibitor Ibrutinib in Combination with Obinutuzumab versus Chlorambucil in Combination with Obinutuzumab in Subjects with Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma chronic lymphocytic leukemia
A Phase 2, Single Arm Study Evaluating the Efficacy and Safety of Idelalisib in Combination with Rituximab in Patients with Previously Untreated Chronic Lymphocytic Leukemia with 17p Deletion chronic lymphocytic leukemia
A Multicenter Phase 3 Randomized, Open-Label Study of Bosutinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia chronic Myelogenous Leukemia
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib in Combination with Bendamustine and Rituximab for Previously Untreated Chronic Lymphocytic Leukemia Leukemia
Allogenic stem cell transplantation in children and adolescents with acute lymphoblastic leukaemia lymphoblastic leukaemia
An Open-label Extension of Study HGT-MLD-070 Evaluating Long Term Safety and Efficacy of Intrathecal Administration of HGT-1110 in Patients with Metachromatic Leukodystrophy metachromatic leukodystrophy
Treatment optimization of newly diagnosed Ph/BCR-ABL positive patients with chronic myeloid leukemia (CML) in chronic phase with nilotinib vs. nilotinib plus interferon alpha induction and nilotinib or interferon alpha maintenance therapy. chronic myeloid leukemia
International randomized phase III study on the treatment of children and adolescents with refractory or relapsed acute myeloid leukemia Leukemia
A Phase 3, Randomized, Open Label Study Investigating the Efficacy of the BiTE? Antibody Blinatumomab Versus Standard of Care Chemotherapy in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (TOWER Study) Leukemia
International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010 leukemia Acute lymphoblastic leukemia
A confirmatory multicenter, single-arm study to assess the efficacy, safety, and tolerability of the BiTE? antibody blinatumomab in adult patients with minimal residual disease (MRD) of B-precursor acute lymphoblastic leukemia lymphoblastic leukemia
A phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare Efficacy and Safety of Oral Azacitidine plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects with Acute Myeloid Leukemia in Complete Remission Acute Myeloid Leukemia
Multicenter trial estimating the persistance of molecular remission in chronic myeloid leukaemia after stopping TKI chronic myeloid leukaemia
Randomized, double-blind, placebo-controlled phase 3 stuy of Ibrutinib,a Bruton´s Tyrosine Kinase (BTK) inhibitor, in combination with Bendamustine and Rituximab (BR) in subjects with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma chronic lymphatic leukemia

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Pursuant to Section 99 par. 1 indent f) (2) of Act No. 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals) as amended, the State Institute for Drug Control publishes information about clinical trials approved in the Czech Republic.
Database included clinical trials approved since the effect of the Act on Pharmaceuticals. Information about clinical trials from the year 2004 – 2007 are being supplemented continuously.
Database, according to Act, doesn´t include bioequivalence trials and clinical trials in phase I (i.e. first-in-man trials, the first stage of testing in human subjects).

Glossary of clinical trials terms:
Sponsor = An individual, company, institution or organization which takes responsibility for the initiation, management and/or financing of a clinical trial.
Study code / Protocol number = trial identifying number for sponsor
EudraCT number = EU trial identifying number
Subject = an individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control; patient or healthy volunteer.
MEK = Ethics Committee for Multicentric Clinical Trials
Double-blind study = A clinical trial design in which neither the participating individuals (subjects) nor the study staff knows which participants are receiving the investigational drug and which are receiving a placebo or another therapy.
Randomized trial = A study in which participants/subjects are randomly (i.e. by chance) assigned to one of two or more treatment arms of a clinical trial.
Multicentric trial = a clinical trial conducted according to a single protocol but at more than one site and therefore, carried out by more than one investigator.
Placebo = an inactive pill, liquid, or powder that has no treatment value.
Last database change: 17. May 2022 at 05:11