ENDURE - Efficacy and Safety of AOP2014 With CML Patients in Remission
NCT ID: NCT03117816
Last Updated: 2023-03-31
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
214 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-05-04
Study Completion Date
2022-12-12
Brief Summary
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A randomized, open-label assessor blinded, multi-center, controlled phase III Trial to evaluate the efficacy of AOP2014 administered bi-weekly subcutaneously (s.c.) in preventing molecular relapse (loss of MMR) in CML patients, who discontinue ABL tyrosine kinase inhibitor therapy (TKI) in deep molecular remission of MR4 or better (MR4.5, or MR5).
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Detailed Description
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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 hypothesis 1 is the primary endpoint and investigates molecular relapse-free survival as a time-to-event variable; the two arms are compared with the log-rank test. Null hypotheses 2, 3, and 4 deal with probabilities of molecular relapse-free survival 7, 13, and 25 months after randomization, respectively; arms A and B are compared with the uncorrected chi-square test.
All four hypotheses are tested at significance level 0.05. Null hypothesis 1 is the primary endpoint and investigates molecular relapse-free survival as a time-to-event variable; the two arms are compared with the log-rank test. Null hypotheses 2, 3, and 4 deal with probabilities of molecular relapse-free survival 7, 13, and 25 months after randomization, respectively; arms A and B are compared with the uncorrected chi-square test.
Conditions
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Chronic Myeloid Leukemia in Remission
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
SINGLE
Outcome Assessors
A randomized, open-label assessor blinded, multi-center, controlled phase III trial
Study Groups
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investigational arm A
There will be an overlapping treatment with AOP2014 and TKI for one month. After one month, the TKI therapy will be stopped and patient will receive only AOP2014 treatment for the next 14 months.
Group Type
EXPERIMENTAL
AOP2014 / Pegylated-Proline-interferon alpha-2b
Intervention Type
DRUG
AOP2014 as pre-filled auto-injection pen for subcutaneous injection, containing 250 µg AOP2014 / 0.5 ml. The solution also contains inactive ingredients (sodium chloride, polysorbate 80, benzyl alcohol, sodium acetate, and acetic acid). The solution is colorless to light yellow.
surveillance arm B
This is an open-label study with a "surveillance" group as comparator arm. Similar as in the arm A, patient will discontinue TKI therapy one month after randomization. From then on patient will receive no further CML treatment.
Group Type
OTHER
Surveillance
Intervention Type
OTHER
For patients randomized into this treatment arm stopp their standard treatment and will just be under observation.
Interventions
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AOP2014 / Pegylated-Proline-interferon alpha-2b
AOP2014 as pre-filled auto-injection pen for subcutaneous injection, containing 250 µg AOP2014 / 0.5 ml. The solution also contains inactive ingredients (sodium chloride, polysorbate 80, benzyl alcohol, sodium acetate, and acetic acid). The solution is colorless to light yellow.
Intervention Type
DRUG
Surveillance
For patients randomized into this treatment arm stopp their standard treatment and will just be under observation.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
1. Signed written informed consent form.
2. Capability and willingness to comply with study procedures and ability to self-administration of the study drug.
3. Male or female aged ≥ 18 years.
4. At least three years of TKI therapy.
5. BCR-ABL-positive, chronic phase CML patients with a transcript level according to the international scale (IS) of at least MR4, or better (MR4.5, MR5). MR4 is defined as (i) detectable disease ≤0.01% BCR-ABL IS or (ii) undetectable disease in cDNA with ≥10,000 ABL or ≥24,000 GUS transcripts for at least one year. There have to be at least three consecutive PCR-results with MR4 or better within the last year (+ months) before study entry. The latest of these PCRs must be a confirmatory MR4 measurement prior to randomization by the EUTOS-certified Study Reference Laboratories for PCR (BCR-ABL mRNA). No PCR-results in the last year before randomisation can be worse than MR4. If the last PCR was not done within two months from baseline (day 0) in an EUTOS-certified study Reference Laboratory; the PCR sample must be sent to an EUTOS-certified study Reference Laboratory at screening.
6. Patients who had failed to discontinue TKI in a prior discontinuation attempt are eligible for this protocol, if they fulfil criterion 5 after retreatment with TKI. A prior TKI discontinuation failure must be specifically indicated at inclusion and documented.
7. Adequate organ function:
especially total bilirubin, lactate dehydrogenase \[LDH\], aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\] and coagulation parameters ≤ 2 × upper limit of normal (ULN)
8. Adequate hematological parameters:
platelet count ≥ 100 × 1000000000/L; white blood cell count ≥ 2.5 × 1000000000/L; lymphocytes ≥ 1.0 × 1000000000/L; hemoglobin ≥ 9.0 g/dL or 5.59 mmol/L.
9. Female patients with reproductive potential must agree to maintain highly effective methods of contraception by practicing abstinence or by using at least two methods of birth control from the date of consent through the end of the study. If abstinence could not be practiced, a combination of hormonal contraceptive (oral, injectable, or implants) and a barrier method (condom, diaphragm with a vaginal spermicidal agent) has to be used. Male patients must agree to use condoms during study participation.
10. Negative serum pregnancy test in women of childbearing potential.
11. Date of diagnosis of CML confirmed by laboratory PCR must be known.
2. Capability and willingness to comply with study procedures and ability to self-administration of the study drug.
3. Male or female aged ≥ 18 years.
4. At least three years of TKI therapy.
5. BCR-ABL-positive, chronic phase CML patients with a transcript level according to the international scale (IS) of at least MR4, or better (MR4.5, MR5). MR4 is defined as (i) detectable disease ≤0.01% BCR-ABL IS or (ii) undetectable disease in cDNA with ≥10,000 ABL or ≥24,000 GUS transcripts for at least one year. There have to be at least three consecutive PCR-results with MR4 or better within the last year (+ months) before study entry. The latest of these PCRs must be a confirmatory MR4 measurement prior to randomization by the EUTOS-certified Study Reference Laboratories for PCR (BCR-ABL mRNA). No PCR-results in the last year before randomisation can be worse than MR4. If the last PCR was not done within two months from baseline (day 0) in an EUTOS-certified study Reference Laboratory; the PCR sample must be sent to an EUTOS-certified study Reference Laboratory at screening.
6. Patients who had failed to discontinue TKI in a prior discontinuation attempt are eligible for this protocol, if they fulfil criterion 5 after retreatment with TKI. A prior TKI discontinuation failure must be specifically indicated at inclusion and documented.
7. Adequate organ function:
especially total bilirubin, lactate dehydrogenase \[LDH\], aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\] and coagulation parameters ≤ 2 × upper limit of normal (ULN)
8. Adequate hematological parameters:
platelet count ≥ 100 × 1000000000/L; white blood cell count ≥ 2.5 × 1000000000/L; lymphocytes ≥ 1.0 × 1000000000/L; hemoglobin ≥ 9.0 g/dL or 5.59 mmol/L.
9. Female patients with reproductive potential must agree to maintain highly effective methods of contraception by practicing abstinence or by using at least two methods of birth control from the date of consent through the end of the study. If abstinence could not be practiced, a combination of hormonal contraceptive (oral, injectable, or implants) and a barrier method (condom, diaphragm with a vaginal spermicidal agent) has to be used. Male patients must agree to use condoms during study participation.
10. Negative serum pregnancy test in women of childbearing potential.
11. Date of diagnosis of CML confirmed by laboratory PCR must be known.
Exclusion Criteria
1. Rare variants of BCR-ABL not quantifiable by RT-PCR according to the international scale (IS).
2. Current or previous autoimmune diseases requiring treatment.
3. Immunosuppressive treatment of any kind; transplant recipients
4. Prior allogeneic stem cell transplantation.
5. Prior pegylated IFN therapy. Prior low dose conventional IFN treatment with ≤ 3 x 3 Mio I.E. / week for less than 1 year is acceptable.
6. History of TKI resistance within the last 4 years of TKI therapy.
7. History of accelerated phase or blast crisis.
8. Hypersensitivity/allergy to the active substance or excipients of the formulation.
9. Severe hepatic dysfunction or decompensated cirrhosis.
10. End stage renal disease (GFR \<15 ml/min)
11. Thyroid disease that cannot be controlled by conventional therapy.
12. Uncontrolled diabetes mellitus
13. Epilepsy or other disorders of the central nervous system.
14. Severe cardiac disease history including unstable or uncontrolled cardiac disease in the previous 6 months.
15. Uncontrolled hypertension
16. Any history of retinopathy e.g. retinal detachment, degeneration or thromboembolic events.
17. Clinically significant concomitant diseases or conditions, which, in the opinion of the investigator, would lead to an unacceptable risk for the patient to participate in the study (please refer also to the actual Investigator Brochure).
18. Other malignancy, except adequately treated superficial bladder cancer, basal or squamous cell carcinoma of the skin, or other cancer(s) for which the patient has been disease free for more than 3 years.
19. Active or uncontrolled infections at the time of randomization.
20. Pregnant and/or nursing women.
21. Use of antibiotic therapy within the last 2 weeks prior to randomization
22. Concurrent use of molecular targeted therapy.
23. Tested HIV sero-positivity or tested active hepatitis B or C infection.
24. Participation in another clinical study with other investigational drugs within 14 days prior to randomization.
25. Vaccination within 1 month prior to randomization.
26. Any medical, mental, psychological or psychiatric condition (particularly severe depression, suicidal ideation or suicide attempt) that in the opinion of the investigator would not permit the patient to complete the study or comply to study procedures.
27. Drug and/or alcohol abuse.
2. Current or previous autoimmune diseases requiring treatment.
3. Immunosuppressive treatment of any kind; transplant recipients
4. Prior allogeneic stem cell transplantation.
5. Prior pegylated IFN therapy. Prior low dose conventional IFN treatment with ≤ 3 x 3 Mio I.E. / week for less than 1 year is acceptable.
6. History of TKI resistance within the last 4 years of TKI therapy.
7. History of accelerated phase or blast crisis.
8. Hypersensitivity/allergy to the active substance or excipients of the formulation.
9. Severe hepatic dysfunction or decompensated cirrhosis.
10. End stage renal disease (GFR \<15 ml/min)
11. Thyroid disease that cannot be controlled by conventional therapy.
12. Uncontrolled diabetes mellitus
13. Epilepsy or other disorders of the central nervous system.
14. Severe cardiac disease history including unstable or uncontrolled cardiac disease in the previous 6 months.
15. Uncontrolled hypertension
16. Any history of retinopathy e.g. retinal detachment, degeneration or thromboembolic events.
17. Clinically significant concomitant diseases or conditions, which, in the opinion of the investigator, would lead to an unacceptable risk for the patient to participate in the study (please refer also to the actual Investigator Brochure).
18. Other malignancy, except adequately treated superficial bladder cancer, basal or squamous cell carcinoma of the skin, or other cancer(s) for which the patient has been disease free for more than 3 years.
19. Active or uncontrolled infections at the time of randomization.
20. Pregnant and/or nursing women.
21. Use of antibiotic therapy within the last 2 weeks prior to randomization
22. Concurrent use of molecular targeted therapy.
23. Tested HIV sero-positivity or tested active hepatitis B or C infection.
24. Participation in another clinical study with other investigational drugs within 14 days prior to randomization.
25. Vaccination within 1 month prior to randomization.
26. Any medical, mental, psychological or psychiatric condition (particularly severe depression, suicidal ideation or suicide attempt) that in the opinion of the investigator would not permit the patient to complete the study or comply to study procedures.
27. Drug and/or alcohol abuse.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Deutsche Krebshilfe e.V., Bonn (Germany)
OTHER
Sponsor Role
collaborator
AOP Orphan Pharmaceuticals AG
INDUSTRY
Sponsor Role
collaborator
Philipps University Marburg
OTHER
Sponsor Role
lead
Responsible Party
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Kerstin Balthasar
KKS Marburg Sponsor representative
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Andreas Burchert, Prof. Dr.
Role: STUDY_DIRECTOR
Philipps University Marburg
Franck E Nicoloni, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Léon Bérard, Lyon
Locations
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Institut Bergonié
Bordeaux, , France
Site Status
Centre Léon Bérard
Lyon, , France
Site Status
CHRU de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, , France
Site Status
03 Universitätsklinikum Aachen, Hämatologie/Onkologie
Aachen, , Germany
Site Status
18 Studienzentrum Aschaffenburg
Aschaffenburg, , Germany
Site Status
06 Universitätsmedizin Berlin Charite- Campus Virchow Klinikum, Klinik für Hämatologie und Onkologie
Berlin, , Germany
Site Status
19 Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III
Bonn, , Germany
Site Status
16 Klinikum Bremen Mitte, Medizinische Klinik I
Bremen, , Germany
Site Status
22 BAG / Onkologische Gemeinschaftspraxis
Dresden, , Germany
Site Status
05 Universitätsklinikum Düsseldorf, Klinik für Hämatologie, Onkologie und Klinische Immunologie
Düsseldorf, , Germany
Site Status
07 Universitätsklinikum Erlangen, Medizinische Klinik 5
Erlangen, , Germany
Site Status
20 Universitätsklinikum Essen, Klinik für Hämatologie
Essen, , Germany
Site Status
17 Klinikum der Goethe Universität, Medizinische Klinik II
Frankfurt A. Main, , Germany
Site Status
21 Universitätsklinikum Hamburg Eppendorf, Klinik für Onkologie, Hämatologie und KMT
Hamburg, , Germany
Site Status
23 Evangelische Krankenhaus Hamm gGmbH, Klinik für Hämatologie, Onkologie und Palliativmedizin
Hamm, , Germany
Site Status
02 Universitätsklinikum Jena, linik für Innere Medizin II Abt. für Hämatologie und Internistische Onkologie
Jena, , Germany
Site Status
24 Institut für Versorgungsforschung in der Onkologie GbR
Koblenz, , Germany
Site Status
13 Universitätsklinikum Leipzig, Abteilung für Hämatologie u. Internistische Onkologie
Leipzig, , Germany
Site Status
14 Johannes-Gutenberg-Universität III. Medizinische Klinik
Mainz, , Germany
Site Status
04 Universitätsmedizin Mannheim, III. Medizinische Klinik
Mannheim, , Germany
Site Status
01 Universitätsklinikum Gießen und Marburg GmbH, Standort Marburg, Klinik für Hämatologie, Onkologie und Immunologie
Marburg, , Germany
Site Status
10 Technische Universität München (TUM) Klinikum rechts der Isar, III. Medizinische Klinik und Poliklinik
Munich, , Germany
Site Status
08 Universitätsklinikum Münster, Medizinische Klinik, Innere Medizin A
Münster, , Germany
Site Status
09 Universitätsklinikum Tübingen, Medizinische Klinik
Tübingen, , Germany
Site Status
12 Universitätsklinikum Ulm, Klinik für Innere Medizin III
Ulm, , Germany
Site Status
15 Universitätsklinikum Würzburg, Zentrum für Innere Medizin
Würzburg, , Germany
Site Status
Countries
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France
Germany
References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016-001030-94
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
KKS-227
Identifier Type: -
Identifier Source: org_study_id
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