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TKI and Interferon Alpha Evaluation Initiated by the German Chronic Myeloid Leukemia Study Group - the TIGER Study (TIGER)

Primary Purpose

Chronic Myeloid Leukemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Peginterferon α2b
Nilotinib
Sponsored by
University of Jena
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Myeloid Leukemia focused on measuring CML, Tasigna, Nilotinib, Interferon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female patients with diagnosis of CP-CML with cytogenetic confirmation of Ph chromosome [t(9;22)(q34;q11)]
  • Ph negative cases or patients with variant translocations who are BCR-ABL positive in multiplex PCR (Cross, et al 1994) are eligible as well
  • ECOG performance status of < 2
  • Pretreatment with hydroxyurea for 6 months and imatinib or nilotinib for a duration of up to 6 weeks is permitted
  • Age ≥ 18 years old (no upper age limit given)
  • Normal serum levels ≥ LLN (lower limit of normal) of potassium, magnesium, total calcium corrected for serum albumin, or corrected to within normal limits with supplements
  • ASAT and ALAT ≤ 2.5 x ULN (upper limit of normal) or ≤ 5.0 x ULN if considered due to leukemia
  • Alkaline phosphatase ≤ 2.5 x ULN unless considered due to leukemia
  • Total bilirubin ≤ 1.5 x ULN, except known Mb. Gilbert
  • Serum lipase and amylase ≤ 1.5 x ULN
  • Serum creatinine ≤ 2 x ULN
  • Written informed consent prior to any study procedures being performed

Exclusion Criteria:

  • Known impaired cardiac function, including any of the following:

    • Left ventricular ejection fraction (LVEF) < 45%
    • Congenital long QT syndrome
    • History of or presence of clinically significant ventricular or atrial tachyarrhythmias
  • Clinically significant resting bradycardia (< 50 beats per minute)
  • QTc > 450 msec on screening ECG. If QTc > 450 ms and electrolytes are not within normal ranges before nilotinib dosing, electrolytes should be corrected and then the patient rescreened for QTc criterion
  • Myocardial infarction within 12 months prior to starting therapy
  • Other clinical significant heart disease (e.g. unstable angina, congestive heart failure, uncontrolled hypertension)
  • History of acute (i.e., within 1 year of starting study medication) or chronic pancreatitis
  • Acute or chronic viral hepatitis with moderate or severe hepatic impairment (Child-Pugh scores > 6), even if controlled
  • Other concurrent uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infections, acute or chronic liver and renal disease) that could cause unacceptable safety risks or compromise compliance with the protocol
  • Impaired gastrointestinal function or disease that may alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting and diarrhea, malabsorption syndrome, small bowel resection or gastric by-pass surgery)
  • Concomitant medications with potential QT prolongation
  • Concomitant medications known to be strong inducers or inhibitors of the CYP450 isoenzyme CYP3A4
  • Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
  • Patients who are pregnant or breast feeding, or women of reproductive potential not employing an effective method of birth control. (Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to administration of nilotinib). Post menopausal women must be amenorrheic for at least 12 months in order to be considered of non-childbearing potential. Female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug
  • Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)
  • Active autoimmune disorder, including autoimmune hepatitis
  • Known serious hypersensitivity reactions to peginterferon alfa-2b or interferon alfa-2b or drug excipients
  • Known serious hypersensitivity reactions to nilotinib
  • Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
  • Patients unwilling or unable to comply with the protocol

Sites / Locations

  • University Hospital and Masaryk University Brno
  • Universitätsklinikum Aachen Medizinische Klinik IV
  • Gesundheitszentrum St. Marien GmbH, Onkologie/ Hämatologie Onkologisches Zentrum
  • MVZ am Klinikum Arnsberg GmbH, Hämatologie - Internistische Onkologie
  • Studienzentrum Drs. Klausmann
  • Klinikum Augsburg
  • Klinikum Bayreuth GmbH
  • Vivantes Netzwerk für Gesundheit GmbH, Klinikum Neukölln, Klinik für Innere Medizin - Hämatologie und Onkologie
  • Charité CVK, CC14, Klinik für Hämatologie und Onkologie
  • Evangelisches Klinikum Bethel
  • Universitätsklinikum Bonn Med. Klinik und Poliklinik III, Hämatologie
  • Zentrum für Ambulante Hämatologie und Onkologie
  • Städtisches Klinikum Braunschweig gGmbh, Medizinische Klinik III - Hämatologie
  • Klinikum Bremen-Mitte gGmbH
  • DIAKO Ev. Diakonie-Krankenhaus gGmbH, Medizinische Klinik II
  • Klinikum Chemnitz gGmbH Klinik für Innere Medizin III
  • Onkologische Schwerpunktpraxis
  • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
  • Onkologisch-Hämatologische Schwerpunktpraxis
  • Dr. med. Ulrich Hauch
  • Onkologische Schwerpunktpraxis Erlangen, Onkologie, Hämatologie
  • Universitätsklinikum Erlangen Medizinische Klinik 5 - Hämatologie und int. Onkologie
  • St.-Antonius-Hospital, Klinik für Hämatologie Onkologie
  • Klinik für Hämatologie Universitätsklinikum Essen
  • Klinikum der Goethe Universität
  • Universitätsklinikum Freiburg Abteilung Innere Medizin I - Hämatologie und Onkologie
  • MVZ-Osthessen GmbH Klinikum Fulda Tumorklinik
  • Praxis Dr. med. Schmitt
  • Dr. med. Hans Werner Tessen, Facharzt für Innere Medizin
  • Universitätsmedizin Greifswald, Klinik und Poliklinik für Innere
  • Georg-August Universität Göttingen Abteilung Hämatologie und Onkologie
  • Internistische Gemeinschaftspraxis
  • Katholisches Krankenhaus Hagen gem. GmbH, Klinik für Hämatologie und
  • Universitätsklinikum Halle (Saale)
  • Gemeinschaftspraxis Hämatologie und internistische
  • Asklepios Klinik St. Georg, Abteilung Hämatologie, Onkologie, Stammzelltransplantation
  • Universitätsklinikum Hamburg- Eppendorf, Medizinische Klinik 2
  • Evangelisches Krankenhaus Hamm
  • St. Barbara-Klinik, Standort St. Josef
  • Mediprojekt, Gesellschaft für Medizinstatistik und Projektentwicklung
  • Medizinische Hochschule Hannover, Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
  • Universitätsklinikum Heidelberg Innere Medizin V: Hämatologie, Onkologie und Rheumatologie
  • Internistische Gemeinschaftspraxis Heilbronn
  • St. Bernward Krankenhaus Hildesheim
  • Universitätsklinikum des Saarlandes Klinik für Innere Medizin I
  • Klinikum Idar-Oberstein GmbH, Innere Medizin I (Hämatologie/Onkologie)
  • MVZ Onkologie Ingolstadt
  • Universitätsklinikum Jena, Klinik für Innere Medizin II, Abt. Hämatologie und internistische Onkologie
  • Westpfalz-Klinikum GmbH Innere 1
  • Städtisches Klinikum Karlsruhe gGmbH, Medizinische Klinik III: Hämatologie/Onkologie
  • St. Vincentius-Kliniken Karlsruhe
  • Klinikum Kempten Oberallgäu gGmbH
  • Universitätsklinikum Schleswig-Holstein, II. Medizinische Klinik und Poliklinik im Städtischen Krankenhaus Kiel
  • InVO, Institut für Versorgungsforschung in der Onkologie
  • Onkologische Gemeinschaftspraxis Dr. M. Neise u. Dr. A. Lollert
  • Onkologische Schwerpunktpraxis
  • Universitätsklinikum Köln
  • Onkologisches Zentrum Gemeinschaftspraxis für Hämato-/ Onkologie, Abt. für Hämato-/ Onkologie im Caritas Krankenhaus
  • Onkologisches Schwerpunktpraxis
  • Universitätsklinikum Leipzig, Department für Innere Medizin
  • Dr. Aldaoud - Dr. Schwarzer Forschungsgesellschaft mbH
  • Krankenhausgesellschaft St. Vincenz mbH Limburg
  • Gemeinschaftspraxis Uhle, Müller, Kröning, Jentsch-Ullrich
  • Internistische Gemeinschaftspraxis Onkologie/Hämatologie
  • Universitätsmedizin der Johannes- Gutenberg Universität Mainz, III. Medizinische Klinik und Poliklinik, Hämatologie, internistische Onkologie und Pneumologie
  • Mannheimer Onkologie Praxis
  • Universitätsmedizin Mannheim III. Medizinische Klinik
  • Klinikum der Philipps-Universität Marburg, Klinik für Innere Medizin, Schwerpunkt Hämatologie, Onkologie und Immunologie
  • Johannes Wesling Klinikum Minden, Mühlenkreikliniken (AöR), Hämatologie/Onkologie
  • Drs. Schmidt/Schauenberg Onkologie
  • Stauferklinikum Schwäbisch Gmünd, Zentrum Innere Medizin
  • Hämatologisch-Onkologische Gemeinschaftspraxis
  • Gemeinschaftspraxis Hämatologie/ Onkologie
  • MHP Münchener Hämatologie Praxis
  • Universitätsklinikum Grosshadern LMU München
  • Klinikum rechts der Isar, III. Medizinische Klinik und Poliklinik
  • Hämatologisch-Onkologische Schwerpunktpraxis
  • Onkologische und hämatologische Schwerpunktpraxis
  • MVZ I des Klinikums Nürnberg
  • Klinikum Oldenburg Klinik für Onkologie und Hämatologie / Innere Medizin II
  • Brüderkrankenhaus St. Josef Paderborn
  • Klinikum Passau, II. Medizinische Klinik
  • MVZ für Blut- und Krebserkrankungen
  • Klinikum Vest, Behandlungszentrum Recklinghausen, Medizinische Klinik III
  • Krankenhaus Barmherzige Brüder Regensburg, Klinik für Onkologie und Hämatologie
  • Universitätsklinikum Regensburg Abteilung für Hämatologie und internistische Onkologie
  • Kreiskliniken Reutlingen GmbH, Klinikum am Steinenberg, Medizinische Klinik I
  • Universitätsmedizin Rostock, ZIM II Klinik für Hämatologie, Onkologie und
  • Agaplesion Diakonieklinikum Rotenburg
  • Leopoldina-Krankenhaus
  • Diakonie-Klinikum Schwäbisch Hall gGmbH, Innere Medizin III: Sektion für Onkologie und Hämatologie
  • Klinikverbund Südwest, Kliniken Sindelfingen-Böblingen gGmbH
  • Diakonie Klinikum Stuttgart, Medizinische Klinik
  • Klinikum Mutterhaus der Borromäerinnen
  • Medizinische Universitätsklinik, Department für Innere Medizin GCP Studienzentrale der Abteilung 2
  • Universitätsklinikum Ulm Klinik für Innere Medizin III
  • Medizinisches Versorgungszentrum GmbH
  • Dres. med. T. Kamp - R. Eckert Innere/Hämatologie/Onkologie
  • Rems-Murr-Klinik Winnenden
  • Onkologische Gemeinschaftspraxis Würselen und Stolberg
  • Universitätsklinikum Würzburg Medizinische Klinik und Poliklinik II
  • Heinrich-Braun-Klinikum gGmbH
  • Kantonspital Aarau AG
  • Kantonspital Baden
  • Universitätsspital Basel
  • IOSI; Oncology Institute of Southern Switzerland
  • Inselspital Bern
  • Hopitaux Universitaires de Genève
  • Département d'oncologie UNIL-CHUV
  • Kantonsspital Baselland
  • Luzerner Kantonsspital
  • Universitätsspital Zürich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nilotinib+IFN

Nilotinib

Arm Description

Patients will receive nilotinib 300 mg BID given as two 150 mg capsules twice daily with Peginterferon α2b at a starting target dose of 30μg/week.

Patients will receive nilotinib 300 mg BID given as two 150 mg capsules twice daily.

Outcomes

Primary Outcome Measures

MMR rate at 18 months of nilotinib monotherapy versus nilotinib+pegylated interferon alpha
rate of MMR 18 months after randomization for each study treatment
rate of continuous MMR after discontinuation of nilotinib versus pegylated interferon alpha
rate of patients with molecular relapse (loss of MMR) 12 months after discontinuation of any treatment for CML

Secondary Outcome Measures

rate of CCyR and MMR
Time to CCyR, MMR, MR4 and MR4.5
this time to-event endpoints give an impression of the velocity of drug response and of the time until a certain remission should be waited for
rate of MR4 and MR4.5 during maintenance therapy and after discontinuation
Progression-Free Survival (PFS)
Rate of patients off treatment for at least 6 months
all patients and comparison of treatment arms
safety and tolerability profile of nilotinib in comparison with nilotinib+pegylated interferon alpha and pegylated interferon alpha
the time of risk is the time while receiving the therapy plus 28 days thereafter
patients compliance to nilotinib based therapies
quality of life during induction therapy with ilotinib versus nilotinib+pegylated interferon alpha and during maintenance therapy with nilotinib versus pegylated interferon alpha
pharmacoeconomics of the treatment strategies
Overall Survival (OS)

Full Information

First Posted
July 9, 2012
Last Updated
May 9, 2023
Sponsor
University of Jena
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1. Study Identification

Unique Protocol Identification Number
NCT01657604
Brief Title
TKI and Interferon Alpha Evaluation Initiated by the German Chronic Myeloid Leukemia Study Group - the TIGER Study
Acronym
TIGER
Official Title
Treatment Optimization of Newly Diagnosed Ph/BCR-ABL Positive Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase With Nilotinib vs. Nilotinib Plus Interferon Alpha Induction and Nilotinib or Interferon Alpha Maintenance Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 24, 2012 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jena

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Advances in Chronic Myeloid Leukemia (CML) therapy led to an expected survival prolongation of > 20 years after diagnosis. So far, discontinuation of tyrosine kinase inhibitors led to recurrence of disease in the majority of patients. The trial aims to improve treatment strategies in CML by improving induction therapy and deescalating maintenance therapy using low dose IFN as inducer of immunosurveillance. The trial will provide important data on the duration of active therapy in CML patients. Considering the rapidly increasing prevalence of CML this is of individual but also socioeconomic importance.
Detailed Description
Objectives Primary: Evaluation of the major molecular response (MMR) rate at 18 months of nilotinib compared to nilotinib+pegylated Interferon alpha (IFN) in adult patients with newly diagnosed Ph/BCR-ABL CML in chronic phase. Evaluation of the feasibility to discontinue drug therapy in stable deep molecular response (MR4) after nilotinib versus IFN maintenance therapy. Secondary: Evaluation of the efficacy and tolerability of IFN added to nilotinib 2x300 mg/day. Evaluation of the efficacy and tolerability of a maintenance therapy with nilotinib versus IFN after stable MMR after at least 24 months of nilotinib therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia
Keywords
CML, Tasigna, Nilotinib, Interferon

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
717 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nilotinib+IFN
Arm Type
Experimental
Arm Description
Patients will receive nilotinib 300 mg BID given as two 150 mg capsules twice daily with Peginterferon α2b at a starting target dose of 30μg/week.
Arm Title
Nilotinib
Arm Type
Active Comparator
Arm Description
Patients will receive nilotinib 300 mg BID given as two 150 mg capsules twice daily.
Intervention Type
Drug
Intervention Name(s)
Peginterferon α2b
Other Intervention Name(s)
Redipen
Intervention Description
Patients will receive nilotinib 300 mg BID given as two 150 mg capsules twice daily with at a starting target dose of 30μg/week. After confirmed MMR or at least 24 mo. after start of therapy, maintenance therapy (nilotinib will be discontinued) will start for a study duration of up to 5 years.
Intervention Type
Drug
Intervention Name(s)
Nilotinib
Other Intervention Name(s)
Tasigna
Intervention Description
Patients will receive nilotinib 300 mg BID given as two 150 mg capsules twice daily for a study duration of up to 5 years.
Primary Outcome Measure Information:
Title
MMR rate at 18 months of nilotinib monotherapy versus nilotinib+pegylated interferon alpha
Description
rate of MMR 18 months after randomization for each study treatment
Time Frame
at least 18 months after start of study treatment
Title
rate of continuous MMR after discontinuation of nilotinib versus pegylated interferon alpha
Description
rate of patients with molecular relapse (loss of MMR) 12 months after discontinuation of any treatment for CML
Time Frame
at least 12 months after stopping all therapy
Secondary Outcome Measure Information:
Title
rate of CCyR and MMR
Time Frame
at 12, 18 and 24 months after start of treatment
Title
Time to CCyR, MMR, MR4 and MR4.5
Description
this time to-event endpoints give an impression of the velocity of drug response and of the time until a certain remission should be waited for
Time Frame
date of randomization until time to endpoints or end of study duration (at least 36 months)
Title
rate of MR4 and MR4.5 during maintenance therapy and after discontinuation
Time Frame
start of maintenance therapy (after at least 24 months of treatment) until end of study duration (at least 36 months)
Title
Progression-Free Survival (PFS)
Time Frame
at 12, 24 and 60 months after start of treatment
Title
Rate of patients off treatment for at least 6 months
Description
all patients and comparison of treatment arms
Time Frame
at 60 months after start of treatment
Title
safety and tolerability profile of nilotinib in comparison with nilotinib+pegylated interferon alpha and pegylated interferon alpha
Description
the time of risk is the time while receiving the therapy plus 28 days thereafter
Time Frame
time of first study treatment until 28 days after stop of study treatment (expected 36 months)
Title
patients compliance to nilotinib based therapies
Time Frame
until stop of study treatment (at least 36 months)
Title
quality of life during induction therapy with ilotinib versus nilotinib+pegylated interferon alpha and during maintenance therapy with nilotinib versus pegylated interferon alpha
Time Frame
during induction therapy (until at least 24 months), during maintenance therapy (until at least 36 months)
Title
pharmacoeconomics of the treatment strategies
Time Frame
after end of study (expected in December 2020) (up to 8 years)
Title
Overall Survival (OS)
Time Frame
at 12, 24 and 60 months after start of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients with diagnosis of CP-CML with cytogenetic confirmation of Ph chromosome [t(9;22)(q34;q11)] Ph negative cases or patients with variant translocations who are BCR-ABL positive in multiplex PCR (Cross, et al 1994) are eligible as well ECOG performance status of < 2 Pretreatment with hydroxyurea for 6 months and imatinib or nilotinib for a duration of up to 6 weeks is permitted Age ≥ 18 years old (no upper age limit given) Normal serum levels ≥ LLN (lower limit of normal) of potassium, magnesium, total calcium corrected for serum albumin, or corrected to within normal limits with supplements ASAT and ALAT ≤ 2.5 x ULN (upper limit of normal) or ≤ 5.0 x ULN if considered due to leukemia Alkaline phosphatase ≤ 2.5 x ULN unless considered due to leukemia Total bilirubin ≤ 1.5 x ULN, except known Mb. Gilbert Serum lipase and amylase ≤ 1.5 x ULN Serum creatinine ≤ 2 x ULN Written informed consent prior to any study procedures being performed Exclusion Criteria: Known impaired cardiac function, including any of the following: Left ventricular ejection fraction (LVEF) < 45% Congenital long QT syndrome History of or presence of clinically significant ventricular or atrial tachyarrhythmias Clinically significant resting bradycardia (< 50 beats per minute) QTc > 450 msec on screening ECG. If QTc > 450 ms and electrolytes are not within normal ranges before nilotinib dosing, electrolytes should be corrected and then the patient rescreened for QTc criterion Myocardial infarction within 12 months prior to starting therapy Other clinical significant heart disease (e.g. unstable angina, congestive heart failure, uncontrolled hypertension) History of acute (i.e., within 1 year of starting study medication) or chronic pancreatitis Acute or chronic viral hepatitis with moderate or severe hepatic impairment (Child-Pugh scores > 6), even if controlled Other concurrent uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infections, acute or chronic liver and renal disease) that could cause unacceptable safety risks or compromise compliance with the protocol Impaired gastrointestinal function or disease that may alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting and diarrhea, malabsorption syndrome, small bowel resection or gastric by-pass surgery) Concomitant medications with potential QT prolongation Concomitant medications known to be strong inducers or inhibitors of the CYP450 isoenzyme CYP3A4 Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy Patients who are pregnant or breast feeding, or women of reproductive potential not employing an effective method of birth control. (Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to administration of nilotinib). Post menopausal women must be amenorrheic for at least 12 months in order to be considered of non-childbearing potential. Female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory) Active autoimmune disorder, including autoimmune hepatitis Known serious hypersensitivity reactions to peginterferon alfa-2b or interferon alfa-2b or drug excipients Known serious hypersensitivity reactions to nilotinib Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention Patients unwilling or unable to comply with the protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Hochhaus, Prof. MD
Organizational Affiliation
Jena University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital and Masaryk University Brno
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Facility Name
Universitätsklinikum Aachen Medizinische Klinik IV
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Gesundheitszentrum St. Marien GmbH, Onkologie/ Hämatologie Onkologisches Zentrum
City
Amberg
ZIP/Postal Code
92224
Country
Germany
Facility Name
MVZ am Klinikum Arnsberg GmbH, Hämatologie - Internistische Onkologie
City
Arnsberg
ZIP/Postal Code
56755
Country
Germany
Facility Name
Studienzentrum Drs. Klausmann
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Klinikum Augsburg
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Facility Name
Klinikum Bayreuth GmbH
City
Bayreuth
ZIP/Postal Code
95445
Country
Germany
Facility Name
Vivantes Netzwerk für Gesundheit GmbH, Klinikum Neukölln, Klinik für Innere Medizin - Hämatologie und Onkologie
City
Berlin
ZIP/Postal Code
12351
Country
Germany
Facility Name
Charité CVK, CC14, Klinik für Hämatologie und Onkologie
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Evangelisches Klinikum Bethel
City
Bielefeld
ZIP/Postal Code
33611
Country
Germany
Facility Name
Universitätsklinikum Bonn Med. Klinik und Poliklinik III, Hämatologie
City
Bonn
ZIP/Postal Code
53111
Country
Germany
Facility Name
Zentrum für Ambulante Hämatologie und Onkologie
City
Bonn
ZIP/Postal Code
53113
Country
Germany
Facility Name
Städtisches Klinikum Braunschweig gGmbh, Medizinische Klinik III - Hämatologie
City
Braunschweig
ZIP/Postal Code
38114
Country
Germany
Facility Name
Klinikum Bremen-Mitte gGmbH
City
Bremen
ZIP/Postal Code
28177
Country
Germany
Facility Name
DIAKO Ev. Diakonie-Krankenhaus gGmbH, Medizinische Klinik II
City
Bremen
ZIP/Postal Code
28239
Country
Germany
Facility Name
Klinikum Chemnitz gGmbH Klinik für Innere Medizin III
City
Chemnitz
ZIP/Postal Code
09113
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Onkologisch-Hämatologische Schwerpunktpraxis
City
Eisenach
ZIP/Postal Code
99817
Country
Germany
Facility Name
Dr. med. Ulrich Hauch
City
Erfurt
ZIP/Postal Code
99084
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis Erlangen, Onkologie, Hämatologie
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
Facility Name
Universitätsklinikum Erlangen Medizinische Klinik 5 - Hämatologie und int. Onkologie
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
St.-Antonius-Hospital, Klinik für Hämatologie Onkologie
City
Eschweiler
ZIP/Postal Code
52249
Country
Germany
Facility Name
Klinik für Hämatologie Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Klinikum der Goethe Universität
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitätsklinikum Freiburg Abteilung Innere Medizin I - Hämatologie und Onkologie
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
MVZ-Osthessen GmbH Klinikum Fulda Tumorklinik
City
Fulda
ZIP/Postal Code
36043
Country
Germany
Facility Name
Praxis Dr. med. Schmitt
City
Gerlingen
ZIP/Postal Code
70839
Country
Germany
Facility Name
Dr. med. Hans Werner Tessen, Facharzt für Innere Medizin
City
Goslar
ZIP/Postal Code
38642
Country
Germany
Facility Name
Universitätsmedizin Greifswald, Klinik und Poliklinik für Innere
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Georg-August Universität Göttingen Abteilung Hämatologie und Onkologie
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis
City
Güstrow
ZIP/Postal Code
18273
Country
Germany
Facility Name
Katholisches Krankenhaus Hagen gem. GmbH, Klinik für Hämatologie und
City
Hagen
ZIP/Postal Code
58095
Country
Germany
Facility Name
Universitätsklinikum Halle (Saale)
City
Halle (Saale)
ZIP/Postal Code
06120
Country
Germany
Facility Name
Gemeinschaftspraxis Hämatologie und internistische
City
Halle
ZIP/Postal Code
06110
Country
Germany
Facility Name
Asklepios Klinik St. Georg, Abteilung Hämatologie, Onkologie, Stammzelltransplantation
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Universitätsklinikum Hamburg- Eppendorf, Medizinische Klinik 2
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Evangelisches Krankenhaus Hamm
City
Hamm
ZIP/Postal Code
59063
Country
Germany
Facility Name
St. Barbara-Klinik, Standort St. Josef
City
Hamm
ZIP/Postal Code
59075
Country
Germany
Facility Name
Mediprojekt, Gesellschaft für Medizinstatistik und Projektentwicklung
City
Hannover
ZIP/Postal Code
30171
Country
Germany
Facility Name
Medizinische Hochschule Hannover, Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Heidelberg Innere Medizin V: Hämatologie, Onkologie und Rheumatologie
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis Heilbronn
City
Heilbronn
ZIP/Postal Code
74072
Country
Germany
Facility Name
St. Bernward Krankenhaus Hildesheim
City
Hildesheim
ZIP/Postal Code
31134
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes Klinik für Innere Medizin I
City
Homburg/ Saar
ZIP/Postal Code
66421
Country
Germany
Facility Name
Klinikum Idar-Oberstein GmbH, Innere Medizin I (Hämatologie/Onkologie)
City
Idar-Oberstein
ZIP/Postal Code
55743
Country
Germany
Facility Name
MVZ Onkologie Ingolstadt
City
Ingolstadt
ZIP/Postal Code
85049
Country
Germany
Facility Name
Universitätsklinikum Jena, Klinik für Innere Medizin II, Abt. Hämatologie und internistische Onkologie
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
Westpfalz-Klinikum GmbH Innere 1
City
Kaiserslautern
ZIP/Postal Code
67655
Country
Germany
Facility Name
Städtisches Klinikum Karlsruhe gGmbH, Medizinische Klinik III: Hämatologie/Onkologie
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Facility Name
St. Vincentius-Kliniken Karlsruhe
City
Karlsruhe
ZIP/Postal Code
76137
Country
Germany
Facility Name
Klinikum Kempten Oberallgäu gGmbH
City
Kempten
ZIP/Postal Code
87439
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, II. Medizinische Klinik und Poliklinik im Städtischen Krankenhaus Kiel
City
Kiel
ZIP/Postal Code
24116
Country
Germany
Facility Name
InVO, Institut für Versorgungsforschung in der Onkologie
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
Facility Name
Onkologische Gemeinschaftspraxis Dr. M. Neise u. Dr. A. Lollert
City
Krefeld
ZIP/Postal Code
47805
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis
City
Kronach
ZIP/Postal Code
96317
Country
Germany
Facility Name
Universitätsklinikum Köln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Onkologisches Zentrum Gemeinschaftspraxis für Hämato-/ Onkologie, Abt. für Hämato-/ Onkologie im Caritas Krankenhaus
City
Lebach
ZIP/Postal Code
66822
Country
Germany
Facility Name
Onkologisches Schwerpunktpraxis
City
Leer
ZIP/Postal Code
26789
Country
Germany
Facility Name
Universitätsklinikum Leipzig, Department für Innere Medizin
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Dr. Aldaoud - Dr. Schwarzer Forschungsgesellschaft mbH
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Krankenhausgesellschaft St. Vincenz mbH Limburg
City
Limburg An Der Lahn
ZIP/Postal Code
65549
Country
Germany
Facility Name
Gemeinschaftspraxis Uhle, Müller, Kröning, Jentsch-Ullrich
City
Magdeburg
ZIP/Postal Code
39104
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis Onkologie/Hämatologie
City
Mainz
ZIP/Postal Code
55122
Country
Germany
Facility Name
Universitätsmedizin der Johannes- Gutenberg Universität Mainz, III. Medizinische Klinik und Poliklinik, Hämatologie, internistische Onkologie und Pneumologie
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Mannheimer Onkologie Praxis
City
Mannheim
ZIP/Postal Code
68161
Country
Germany
Facility Name
Universitätsmedizin Mannheim III. Medizinische Klinik
City
Mannheim
ZIP/Postal Code
68169
Country
Germany
Facility Name
Klinikum der Philipps-Universität Marburg, Klinik für Innere Medizin, Schwerpunkt Hämatologie, Onkologie und Immunologie
City
Marburg
ZIP/Postal Code
35032
Country
Germany
Facility Name
Johannes Wesling Klinikum Minden, Mühlenkreikliniken (AöR), Hämatologie/Onkologie
City
Minden
ZIP/Postal Code
32429
Country
Germany
Facility Name
Drs. Schmidt/Schauenberg Onkologie
City
Muhr am See
ZIP/Postal Code
91735
Country
Germany
Facility Name
Stauferklinikum Schwäbisch Gmünd, Zentrum Innere Medizin
City
Mutlangen
ZIP/Postal Code
73557
Country
Germany
Facility Name
Hämatologisch-Onkologische Gemeinschaftspraxis
City
München
ZIP/Postal Code
80638
Country
Germany
Facility Name
Gemeinschaftspraxis Hämatologie/ Onkologie
City
München
ZIP/Postal Code
81241
Country
Germany
Facility Name
MHP Münchener Hämatologie Praxis
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Universitätsklinikum Grosshadern LMU München
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Klinikum rechts der Isar, III. Medizinische Klinik und Poliklinik
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Hämatologisch-Onkologische Schwerpunktpraxis
City
München
ZIP/Postal Code
81679
Country
Germany
Facility Name
Onkologische und hämatologische Schwerpunktpraxis
City
Neumarkt
ZIP/Postal Code
92318
Country
Germany
Facility Name
MVZ I des Klinikums Nürnberg
City
Nürnberg
ZIP/Postal Code
90419
Country
Germany
Facility Name
Klinikum Oldenburg Klinik für Onkologie und Hämatologie / Innere Medizin II
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
Facility Name
Brüderkrankenhaus St. Josef Paderborn
City
Paderborn
ZIP/Postal Code
33098
Country
Germany
Facility Name
Klinikum Passau, II. Medizinische Klinik
City
Passau
ZIP/Postal Code
94032
Country
Germany
Facility Name
MVZ für Blut- und Krebserkrankungen
City
Potsdam
ZIP/Postal Code
14467
Country
Germany
Facility Name
Klinikum Vest, Behandlungszentrum Recklinghausen, Medizinische Klinik III
City
Recklinghausen
ZIP/Postal Code
45657
Country
Germany
Facility Name
Krankenhaus Barmherzige Brüder Regensburg, Klinik für Onkologie und Hämatologie
City
Regensburg
ZIP/Postal Code
93049
Country
Germany
Facility Name
Universitätsklinikum Regensburg Abteilung für Hämatologie und internistische Onkologie
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Kreiskliniken Reutlingen GmbH, Klinikum am Steinenberg, Medizinische Klinik I
City
Reutlingen
ZIP/Postal Code
72764
Country
Germany
Facility Name
Universitätsmedizin Rostock, ZIM II Klinik für Hämatologie, Onkologie und
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Agaplesion Diakonieklinikum Rotenburg
City
Rotenburg
ZIP/Postal Code
27356
Country
Germany
Facility Name
Leopoldina-Krankenhaus
City
Schweinfurt
ZIP/Postal Code
97422
Country
Germany
Facility Name
Diakonie-Klinikum Schwäbisch Hall gGmbH, Innere Medizin III: Sektion für Onkologie und Hämatologie
City
Schwäbisch Hall
ZIP/Postal Code
74523
Country
Germany
Facility Name
Klinikverbund Südwest, Kliniken Sindelfingen-Böblingen gGmbH
City
Sindelfingen
ZIP/Postal Code
71065
Country
Germany
Facility Name
Diakonie Klinikum Stuttgart, Medizinische Klinik
City
Stuttgart
ZIP/Postal Code
70176
Country
Germany
Facility Name
Klinikum Mutterhaus der Borromäerinnen
City
Trier
ZIP/Postal Code
54290
Country
Germany
Facility Name
Medizinische Universitätsklinik, Department für Innere Medizin GCP Studienzentrale der Abteilung 2
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsklinikum Ulm Klinik für Innere Medizin III
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Medizinisches Versorgungszentrum GmbH
City
Weiden
ZIP/Postal Code
92637
Country
Germany
Facility Name
Dres. med. T. Kamp - R. Eckert Innere/Hämatologie/Onkologie
City
Wendlingen
ZIP/Postal Code
73240
Country
Germany
Facility Name
Rems-Murr-Klinik Winnenden
City
Winnenden
ZIP/Postal Code
71334
Country
Germany
Facility Name
Onkologische Gemeinschaftspraxis Würselen und Stolberg
City
Würselen
ZIP/Postal Code
52146
Country
Germany
Facility Name
Universitätsklinikum Würzburg Medizinische Klinik und Poliklinik II
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Heinrich-Braun-Klinikum gGmbH
City
Zwickau
ZIP/Postal Code
08060
Country
Germany
Facility Name
Kantonspital Aarau AG
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
Kantonspital Baden
City
Baden
ZIP/Postal Code
5404
Country
Switzerland
Facility Name
Universitätsspital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
IOSI; Oncology Institute of Southern Switzerland
City
Bellinzona
ZIP/Postal Code
6500
Country
Switzerland
Facility Name
Inselspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Hopitaux Universitaires de Genève
City
Geneve
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Département d'oncologie UNIL-CHUV
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Kantonsspital Baselland
City
Liestal
ZIP/Postal Code
4410
Country
Switzerland
Facility Name
Luzerner Kantonsspital
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
Facility Name
Universitätsspital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

TKI and Interferon Alpha Evaluation Initiated by the German Chronic Myeloid Leukemia Study Group - the TIGER Study

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