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Number of records: 123
Title of the trial Diagnosis
A prospective phase II clinical trial evaluating the effectiveness and safety of withdrawal of tyrosine kinase inhibitors after a previous two-step dose reduction in patients with chronic myeloid leukemia in deep molecular remission chronic myeloid leukemia
IntReALL HR 2010International Study for Treatment of High Risk Childhood Relapsed ALL2010 Leukemia
A Phase 3, Randomized, Open-Label, Crossover Study of ASTX727 (Cedazuridine and Decitabine Fixed-Dose Combination) versus IV Decitabine in Subjects with Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), and Acute Myeloid Leukemia (AML) Leukemia
Single cycle of blinatumomab followed by high-dose chemotherapy in the induction therapy for Ph-negative acute lymphoblastic leukemia in adults. acute lymphoblastic leukemia
B-NHL 2013 - Treatment protocol of the NHL-BFM and the NOPHO study groups for mature aggressive B-cell lymphoma and leukemia in children and adolescents B-cell lymphoma and leukemia
AIEOP-BFM ALL 2017 - International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia children and adolescents with acute lymphoblastic leukemia
A Phase 3, Randomized Study of Zanubrutinib (BGB-311) Compared with Ibrutinib in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Chronic Lymphocytic Leukemia
A Randomized, Open-label, Phase 3 study of the Combination of Ibrutinib plus Venetoclax versus Chlorambucil plus Obinutuzumab for the First-line Treatment of Subjects with Chronic Lymphocytic Leukemia (CLL) /Small Lymphocytic Lymphoma (SLL) Chronic Lymphocytic Leukemia (CLL)
International phase 3 trial in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) testing imatinib in combination with two different cytotoxic chemotherapy backbones lymphoblastic leukemia
A Phase 2 Study of Inotuzumab Ozogamicin (INO) Combined to Chemotherapy in Older Patients with Philadelphia Chromosome-negative CD22+ B-cell Precursor Acute Lymphoblastic Leukemia Lymphoblastic Leukemia
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. lymphoblastic leukemia
A phase III, randomized, double-blind study of chemotherapy with daunorubicin or idarubicin and cytarabine for induction and intermediate dose cytarabine for consolidation plus midostaurin (PKC412) or chemotherapy plus placebo in newly diagnosed patients with FLT-3 mutation negative acute myeloid leukemia (AML) Myeloid leukemia
A Phase II, open-label, single arm study to evaluate the safety, efficacy, and pharmacokinetics of twice daily midostaurin (PKC412) combined with standard chemotherapy and as a single agent post-consolidation therapy in children with untreated FLT3-mutated AML Myeloid leukemia
Carfilzomib and lenalidomide-based treatment for younger and elderly newly diagnosed primary plasma cell leukemia patients Primary plasma cell leukemia
Phase III Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of the Addition of Crenolanib to Salvage Chemotherapy Versus Salvage Chemotherapy Alone in Subjects - 75 Years of Age with Relapsed/Refractory FLT3 Mutated Acute Myeloid Leukemia Refractory FLT3 Mutated Acute Myeloid Leukemia
A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of Venetoclax in Combination with Azacitidine Versus Azacitidine in Treatment Na?ve Subjects with Acute Myeloid Leukemia who are Ineligible for Standard Induction Therapy Acute Myeloid Leukemia
Adoptive transfer of haploidentical ex-vivo expanded NK cells in patients with refractory or relapsed acute myeloid leukemia followed by hematopoietic cell transplantation from haploidentical related donor after sequential conditioning regimen. A monocentric, single-dose escalation, open-label phase IIa study. acute myeloid leukemia
A Randomized, Double-Blind, Placebo Controlled Study of Venetoclax Co-Administered with Low Dose Cytarabine Versus Low Dose Cytarabine in Treatment Na?ve Patients with Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy Acute Myeloid Leukemia
A Phase III, Double-Blind, Placebo-Controlled, Multicenter, Randomized Study Of Pracinostat In Combination With Azacitidine In Patients ?18 Years With Newly Diagnosed Acute Myeloid Leukemia Unfit For Standard Induction Chemotherapy Acute Myeloid 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: 25. May 2022 at 05:11