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Number of records: 109
Title of the trial Diagnosis
A Phase 3, Randomized, Controlled, Double-Blind, Multinational Clinical Study of the Efficacy and Safety of Vosaroxin and Cytarabine Versus Placebo and Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia (VALOR) Acute myeloid leukemia
International collaborative treatment protocol for children and adolescents with acute lymphoblasatic leukemia acute myphoblastic leukemia
Phase III trial of combined immunochemotherapy with Fludarabine, Cyclophosphamide and Rituximab (FCR) versus Bendamustine and Rituximab (BR) in patients with previously untreated chronic lymphocytic leukemia. chronic lymphocytic leukemia
A phase III, open label, randomized, multicenter trial of ofatumumab maintenance treatment versus no further treatment in subjects with relapsed chronic lymphocytic leukemia (CLL) who have responded to induction therapy chronic lymphocytic leukemia (CLL)
A Phase I/II Pharmacokinetic Study of Intravenous and Oral Forodesine in Children with Relapsed or Refractory T-cell or B-cell Precursor Acute Lymphoblastic Leukaemia or T-cell Non- Hodgkin´s Lymphoma Acute Lymphoblastic Leukemia
A phase 3, multicenter, randomized, open-label, parallel-group study of the efficacy and safety of lenalidomide (Revlimid) versus chlorambucil as first-line therapy for previously untreated elderly patients with B-cell chronic lymphocytic leukemia (the origin trial) B-cell chronic lymphocytic leukemia
A Phase IIB, Randomized, Double-Blinded, Placebo-Controlled Study of Low Dose Cytarabine and Lintuzumab Compared to Low Dose Cytarabine and Placebo in Patients 60 Years of Age and Older with Previously Untreated AML. acute myeloid leukaemia
A phase III randomized, double-blind study of induction (daunorubicin/cytarabine) and consolidation (high-dose cytarabine) chemotherapy + midostaurin (PKC 412) (IND # 10161) or placebo in newly diagnosed patients < 60 years of age with FLT3 mutated acute myeloid leukemia (AML). Acute Myeloid Leukemia With FL3 Mutation
A phase 3, multi-center, randomised, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of lenalidomide (Revlimid) as maintenance therapy for patients with b-cell chronic lymphocytic leukemia following second-line therapy (the continuum trial) B-cell chronic lymphocytic leukemia
A Single-Arm, International, Multi-Center Trial Investigating the Efficacy and Safety of Ofatumumab Retreatment and Maintenance Treatment in Patients with B-Cell Chronic Lymphocytic Leukemia who Progressed Following Response or Stable Disease after Ofatumumab Treatment in Hx-CD20-406 B-cell chronic lymphocytic leukemia
A phase III, open label, randomized, multicenter trial of Ofatumumab added to Chlorambucil vs. Chlorambucil monotherapy in previously untreated patients with chronic lymphocytic leukemia Chronic Lymphocytic Leukemia
A randomized, open-label, multicenter, phase II/III study to evaluate the safety and efficacy of Lumiliximab in combination with Fludarabine, Cyclophosphamide and Rituximab versus Fludarabine, Cyclophosphamide and Rituximab alone in subjects with relapsed chronic lymphocytic leukemia. relapsed chronic lymphocytic leukemia
Phase III open-label randomized study of amonafide L-maleate in combination with cytarabine compared to daunorubicin in combination with cytarabine in patients with secondary acute myeloid leukemia (AML) secondary acute myeloid leukemia
A prospective, randomised trial of immediate treatment with Campath versus deferred therapy in patients with previously untreated Binet stage A B-cell chronic lymphocytic leukemia at high risk for disease progression Chronic lymphocytic leukemia
Phase II trial to evaluate the efficacy and safety of subcutaneously administered Alemtuzumab (CAMPATH, MabCampath) in patients with previously treated B cell chronic lymphotic leukemia Chronic lymphocytic leukemia
A phase III multi-center, open label, randomised study of imatinib versus nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP) chronic myelogenous leukemia
Open-label, randomized, multicenter, phase III trial of dasatinib (SPRYCEL) vs. standard dose imatinib (400 mg) in the treatment of subjects with newly diagnosed chronic phase phildelphia chromosome positive chronic myeloid leukemia Chronic Myeloid Leukemia
A phase III, multi-center, open-label, randomised study of the efficacy of nilotinib versus imatinib in adult patients with Philadelphia chromosome positive Ph+ chronic myelogenous leukemia in chronic phase (CML-CP) who have suboptimal cytogenetic response (CyR) on imatinib Myelogenous leukemia
A randomised, phase 3 trial of decitabine versus patient's choice with physician's advice of either supportive care or low-dose cytarabine for the treatment of older patients with newly diagnosed acute myeloid leukemia acute myeloid leukemia
A single-arm, international, multi-center trial of HuMax-CD20, a fully human monoclonal anti-CD20 antibody, in patients with B-cell chronic lymphocytic leukemia who have failed fludarabine and alemtuzumab B-cell 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: 27. November 2020 at 05:11