ENDURE - Efficacy and Safety of AOP2014 With CML Patients in Remission

  • STATUS
    Recruiting
  • End date
    Dec 25, 2024
  • participants needed
    214
  • sponsor
    Philipps University Marburg Medical Center
Updated on 25 January 2021

Summary

A randomized, open-label assessor blinded, multi-center, controlled phase II 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).

Description

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, and 4 deal with probabilities of molecular relapse-free survival 7, 13, and 25 months after randomisation, respectively; arms A and B are compared with the uncorrected chi-square test. Null hypothesis 3 investigates molecular relapse-free survival as a time-to-event variable; the two arms are compared with the log-rank test

Details
Condition Chronic Myeloid Leukemia in Remission
Treatment AOP2014 / Pegylated-Proline-interferon alpha-2b, Surveillance, Surveillance
Clinical Study IdentifierNCT03117816
SponsorPhilipps University Marburg Medical Center
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Chronic Myeloid Leukemia in Remission?
Do you have any of these conditions: Do you have Chronic Myeloid Leukemia in Remission??
Signed written informed consent form
Capability and willingness to comply with study procedures and ability to self-administration of the study drug
Male or female aged 18 years
At least three years of TKI therapy
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
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
Adequate organ function
especially total bilirubin, lactate dehydrogenase [LDH], aspartate
aminotransferase [AST], alanine aminotransferase [ALT] and coagulation
parameters 2 upper limit of normal (ULN)
\. 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
\. 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
\. Negative serum pregnancy test in women of childbearing potential
\. Date of diagnosis of CML confirmed by laboratory PCR must be known

Exclusion Criteria

Rare variants of BCR-ABL not quantifiable by RT-PCR according to the international scale (IS)
Current or previous autoimmune diseases requiring treatment
Immunosuppressive treatment of any kind; transplant recipients
Prior allogeneic stem cell transplantation
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
History of TKI resistance within the last 4 years of TKI therapy
History of accelerated phase or blast crisis
Hypersensitivity/allergy to the active substance or excipients of the formulation
Severe hepatic dysfunction or decompensated cirrhosis
End stage renal disease (GFR <15 ml/min)
Thyroid disease that cannot be controlled by conventional therapy
Uncontrolled diabetes mellitus
Epilepsy or other disorders of the central nervous system
Severe cardiac disease history including unstable or uncontrolled cardiac disease in the previous 6 months
Uncontrolled hypertension
Any history of retinopathy e.g. retinal detachment, degeneration or thromboembolic events
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)
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
Active or uncontrolled infections at the time of randomization
Pregnant and/or nursing women
Use of antibiotic therapy within the last 2 weeks prior to randomization
Concurrent use of molecular targeted therapy
Tested HIV sero-positivity or tested active hepatitis B or C infection
Participation in another clinical study with other investigational drugs within 14 days prior to randomization
Vaccination within 1 month prior to randomization
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
Drug and/or alcohol abuse
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