Hamm, Germany Clinical Trials

The DELTA-trial is designed as a two-arm, double-blind, multicenter randomized-controlled phase- II study of EPAG or placebo in combination with standard-dose DAC treatment as concomitant medication in subjects at least 65 years of age with AML not eligible for intensive chemotherapy and planned therapy with Decitabine (DAC). Patients will be ...

In the first part of the trial, patients will be randomly assigned to receive either 90 mg/m2 or 60 mg/m2 daunorubicin in the first induction cycle in addition to standard dosed cytarabine. Assuming a superiority of 90 mg/m2, 436 patients will be recruited. In the second part of the trial, ...

The purpose of the protocol is to demonstrate that Eziclen/Izinova, an osmotic sulphate-based laxative preparation given on the day before colonoscopy has non-inferior efficacy to Klean-Prep (polyethylene glycol (PEG)-electrolytes) on colon cleansing in adolescents aged 12 to 17 years (inclusive) with a body weight >40 kg, scheduled to undergo a ...

Four hypotheses are tested in hierarchical order. To avoid inflation of type 1 error (false rejection of a null hypothesis), further confirmatory testing has to be stopped as soon as a null hypothesis could not be rejected. All four hypotheses are tested at significance level 0.05. Null hypotheses 1, 2, ...

This is a phase 3, randomized, double-blind, placebo-control global study. The purpose of this study is to compare the effect of quizartinib versus placebo (administered with standard induction and consolidation chemotherapy, then administered as maintenance therapy for up to 12 cycles) on event-free survival in subjects with FLT3-internal tandem duplication ...

Chemoimmunotherapy is the standard of care in first-line treatment of CLL patients without del17p or TP 53 mutation; physically fit patients are treated with fludarabine, cyclophosphamide and rituximab (FCR)1. Due to the high risk of severe neutropenias and infections with FCR, bendamustine and rituximab (BR) must be considered in patients ...

This study aims to assess the optimal duration of nilotinib 300 mg BID consolidation treatment, in order that patients remain in treatment-free remission (MR4.0) 12 months after starting the Treatment-Free Remission (TFR) phase of the study. Rationale CP-CML patients who have received 2 or more calendar years of first-line imatinib ...

This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that over express c-Met (c-Met+) best suited for telisotuzumab vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate efficacy in the selected population(s) (Stage ...

Evaluation of remission status will take place 4 months after treatment. In addition, it will be tested whether patients with non-optimal response will have a benefit from a second cycle of cladribine. Non-optimal response is: patients with detectable residual disease; achievement of partial remission or detectable residual infiltration in the ...

Trastuzumab (T)-containing neoadjuvant chemotherapy has been reported to increase the probability of pathological complete response (pCR) in HER2 positive disease up to 67 %. Large trials revealed pCR rates (no remaining invasive and in situ components) of about 30-40 %, if anthracyclines/taxane based polychemotherapy was applied or about 40-45 % ...