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Clinical trials for XM22

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    7 result(s) found for: XM22. Displaying page 1 of 1.
    EudraCT Number: 2007-005349-39 Sponsor Protocol Number: XM22-02-INT Start Date*: 2008-04-09
    Sponsor Name:BioGeneriX AG
    Full Title: Dose-finding of a fixed dose XM22 in patients with breast cancer receiving 4 cycles of chemotherapy versus 6 mg Neulasta®
    Medical condition: Neutropenia in patients with high risk stage II, stage III or stage IV breast cancer receiving cancer chemotherapy.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Completed) HU (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-004742-18 Sponsor Protocol Number: XM22-07 Start Date*: 2012-04-04
    Sponsor Name:Merckle GmbH, a member of the ratiopharm group, a subsidiary of Teva Pharmaceutical Industries Ltd. Germany
    Full Title: Multicenter, Open-label Study to Assess the Pharmacokinetics, Pharmacodynamics, Efficacy, Safety, Tolerability, and Immunogenicity of a Single, Subcutaneous Dose of 100μg/kg XM22 in 21 Children wit...
    Medical condition: Children with Ewing Family of Tumors or Rhabdomyosarcoma receiving cytotoxic Chemotherapy for malignancy inducing neutropenia
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2009-016000-22 Sponsor Protocol Number: XM22-04 Start Date*: 2010-03-22
    Sponsor Name:BioGeneriX AG
    Full Title: Efficacy and safety of XM22 in patients with non small cell lung cancer receiving cisplatin / etoposide chemotherapy. A multinational, multicentre, randomised, double-blind placebo-controlled study
    Medical condition: Non Small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    12.0 10025054 Lung cancer non-small cell stage IIIB LLT
    12.0 10025055 Lung cancer non-small cell stage IV LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2009-015999-10 Sponsor Protocol Number: XM22-03 Start Date*: 2010-03-02
    Sponsor Name:BioGeneriX AG
    Full Title: Efficacy and Safety of XM22 compared to pegfilgrastim in patients with breast cancer receiving chemotherapy. A multinational, multicentre, randomised, double-blind controlled study
    Medical condition: Breast cancer high risk stage II, III or IV according to AJCC classification
    Disease: Version SOC Term Classification Code Term Level
    12.0 10006200 Breast cancer stage II PT
    12.0 10006201 Breast cancer stage III PT
    12.0 10006202 Breast cancer stage IV PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2015-000087-34 Sponsor Protocol Number: XM22-08 Start Date*: 2015-06-05
    Sponsor Name:Merckle GmbH
    Full Title: An Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Lipegfilgrastim 100 μg/kg B...
    Medical condition: Neutropenia in pediatric patients diagnosed with Ewing family of Tumors or rhabdomyosarcoma receiving chemotherapy
    Disease: Version SOC Term Classification Code Term Level
    19.0 10005329 - Blood and lymphatic system disorders 10029354 Neutropenia PT
    19.0 10005329 - Blood and lymphatic system disorders 10016288 Febrile neutropenia PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) LT (Completed) SK (Completed) CZ (Completed) BG (Completed) DE (Ongoing) ES (Completed) RO (Completed) PL (Completed) BE (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2013-001284-23 Sponsor Protocol Number: XM22-ONC-305 Start Date*: 2013-12-10
    Sponsor Name:Merckle GmbH
    Full Title: A randomized, phase IIIB, open-label, two-arm, multicenter, comparatiVe study on efficacy and safety of lipegfilgrastim (Lonquex, TEVA) in comparison to pegfilgrastim (Neulasta®, Amgen) in elderly ...
    Medical condition: The study population includes patients with aggressive B cell Non-Hodgkin Lymphoma (NHL) planned to receive systemic anti-cancer therapy with at least 6 cycles of R-CHOP-21, according to local stan...
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004864 10066481 Hematological malignancy LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-005096-85 Sponsor Protocol Number: XM22-ONC-40041 Start Date*: 2015-05-25
    Sponsor Name:Merckle GmbH
    Full Title: Safety and Efficacy of LONQUEX® (Lipegfilgrastim) in Comparison to Pegfilgrastim (Neulasta®, Amgen Inc.) and Placebo in Patients with Non-Small-Cell Lung Cancer Receiving First-Line Chemotherapy
    Medical condition: Advanced squamous or non-squamous non-small-cell lung cancer (NSCLC) Stage IIIB/IV
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029521 Non-small cell lung cancer stage IIIB PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) HU (Completed) LV (Completed) PL (Prematurely Ended) GR (Completed) BG (Completed) ES (Completed) HR (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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