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Number of records: 115
Title of the trial Diagnosis
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
A Randomized, Multicenter, Open-label, Phase 3 Study of theBruton?s Tyrosine Kinase Inhibitor PCI-32765 versusChlorambucil in Patients 65 Years or Older with Treatment-naiveChronic Lymphocytic Leukemia or Small LymphocyticLymphoma Chronic lymphocytic Leukemia
An Open-label Extension Study in Patients 65 Years or Older withChronic Lymphocytic Leukemia (CLL) or Small LymphocyticLymphoma (SLL) Who Participated in Study PCYC-1115-CA(PCI-32765 versus Chlorambucil) Chronic Lymphoma Leukemia
An open label, randomized (2:1) Phase 2b study of Dasatinib vs. Imatinib in patients with Chronic Phase Chronic Myeloid Leukemia who have not achieved an optimal response to 3 months of therapy with 400 mg Imatinib Chronic Myeloid Leukemia
A Phase 3 Randomized, Open-Label Study of Ponatinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase Chronic Myeloid Leukemia in Chronic Phase
An Open-label, Randomized Phase 3 Study of Inotuzumab Ozogamicin Compared to a Defined Investigators Choice in Adult Patients with Relapsed or Refractory CD-22 positive acute Lymphoblastic Leukemia (ALL) in Adult Patients with Relapsed or Refractory CD-22 positive acute Lymphoblastic Leukemia (ALL)
A phase III randomised, double-blind, controlled, parallel group study of intravenous volasertib in combination with subcutaneous low-dose cytarabine vs. placebo + low-dose cytarabine in patients ? 65 years with previously untreated acute myeloid leukaemia, who are ineligible for intensive remission induction therapy. myeloid leukaemia
A phase 3 Study to Evaluate the Efficacy and Safety of Dinaciclib or Ofatumumab in Subjects with Refractory Chronic Lymphocytic Leukemia (CLL) Refractory Chronic Lymphocytic Leukemia
An open label, multicenter study investigating the safety and efficacy of ofatumumab therapy versus physicians´choice in patients with bulky fludarabine refractory chronic lymphocytic leukaemia (CLL) chronic lymphocytic 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: 31. July 2021 at 05:11