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Number of records: 109
Title of the trial Diagnosis
A randomised, phase 3 study in previously untreated patients with biological high-risk CLL: fludarabin + cyclophosphamide (FC) versus FC + low-dose alemtuzumab chronic lymphocytic leukemia
A randomised, open-label stud y of 400 mg versus 800 mg of Gleevec/Glivec (imatinib mesylate) in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP) using molecular endpoints chronic myeloid leukamia
A randomised, phase 2 trial with infliximab (Remicade) in patients with myelodysplastic syndrome and a relatively low risk of developing acute leukemia acute leukemia
A phase 3 trial of combined immunochemotherapy with fludarabine, cyclophosphamide and rituximab (FCR) versus chemotherapy with fludarabine and cyclophosphamide (FC) alone in patients with previously untreated chronic lymphocytic leukaemia chronic lymphocytic leukaemia
An open-label, multi-center, expanded access study of oral AMN107 in adult patients with imatinib- (Glivec(R)/Gleevec(R)) -resistant or -intolerant chronic myeloid leukemia in blast crisis, accelerated phase or chronic phase chronic myeloid leukemia
A pivotal, randomised study of lonafarnib (SCH 66336) versus placebo in the treatment of subjects with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) who are platelet transfusion dependent, with or without anemia myelodysplastic syndrome or chronic myelomonocytic leukemia
A Randomized Two-by-Two, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 50 mg or 70 mg Twice Daily or 100 mg or 140 mg Once Daily in Subjects with Chronic Phase Philadelphia Chromosome or BCR-ABL Positive Chronic Myelogenous Leukemia Who are Resistant or Intolerant to Imatinib Mesylate (Gleevec(R)) myelogenous leukemia
A Randomized Two-Arm, Multicenter, Open-Label Phase II Study of BMS-354825 Administered Orally at a Dose of 70 mg Twice Daily or 140 mg Once Daily in Subjects with Chronic Myeloid Leukemia in Accelerated Phase or in Myeloid or Lymphoid Blast Phase or with Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia who are Resistant or Intolerant to Imatinib Mesylate (Gleevec) myeloid leukemia
GvHD prophylaxis with ATG-Fresenius S in allogeneic stem cell transplantation from matched unrelated donors: a randomised phase III multi-center trial comparing a standard GvHD prophylaxis with cyclosporine A and methotrexate with additional transplant ATG-Fresenius S acute lymphoblastic/myeloid leukemia, myelodysplastic syndrome

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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