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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 07/10/2020.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 07/10/2020.

Low-dose AZA, Pioglitazone, ATRA Versus Standard-dose AZA in Patients >=60 Years With Refractory AML

Clinicaltrials.gov identifier NCT02942758

Recruitment Status Recruiting

First Posted October 24, 2016

Last update posted October 11, 2018

Study Description

Brief summary:

Diagnosis: Acute myeloid leukemia refractory to intensive induction chemotherapy; Age ≥ 60 years, no upper age limit; Study drug: low-dose azacitidine, pioglitazone, ATRA; Safety Run-In Phase; randomized Phase II, open-label - Safety Run-In Phase: Based on a 3 + 3 modified design, the tolerable dose of ATRA for the randomized phase II is defined. - Phase II: Experimental Arm: low-dose azacitidine, pioglitazone, ATRA; Standard Arm: standard-dose azacitidine; in both arms patients can receive further cycles (with no limit to the number given) as long as clinically appropriate

  • Condition or Disease:Acute Myeloid Leukemia
  • Intervention/Treatment: Drug: low-dose Azacitidine
    Drug: Pioglitazone
    Drug: ATRA
    Drug: standard-dose AZA
  • Phase: Phase 2
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 94 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Randomized Phase II Trial With Safety run-in Phase Evaluating Low-dose AZA, ATRA and Pioglitazone Versus Standard Dose Azacitidine in Patients >=60 Years With AML Who Are Refractory to Standard Induction Chemotherapy
  • Actual Study Start Date: April 2017
  • Estimated Primary Completion Date: February 2020
  • Estimated Study Completion Date: February 2020
Arms and interventions
Arm Intervention/treatment
Experimental: low-dose AZA / ATRA / Pioglitazone
low-dose azacitidine (75 mg/d), ATRA, pioglitazone
Drug: low-dose Azacitidine
Azacitidine 75 mg/d s.c. for 7 days, repeated 28-day treatment cycle

Drug: Pioglitazone
Pioglitazone 45 mg p.o. continuously from day 1

Drug: ATRA
ATRA *45 mg/m² p.o. from day 1 to 28, 15 mg/m² from day 29 continuously; *this regimen will be chosen for the first dose to be evaluated.
Active Comparator: standard-dose AZA
standard-dose azacitidine (75mg/m²/d)
Drug: standard-dose AZA
Azacitidine 75 mg/m²/d s.c. for 7 days, repeated 28-day treatment cycle
Outcome Measures
  • Primary Outcome Measures: 1. overall Survival [ Time Frame: 3 years ]
  • Secondary Outcome Measures: 1. complete remission (CR) rate [ Time Frame: 3 years ]
  • 2. complete remission with incomplete blood count recovery (CRi) rate [ Time Frame: 3 years ]
  • 3. partial remission (PR) rate [ Time Frame: 3 years ]
  • 4. hematological improvement (HI) rate [ Time Frame: 3 years ]
  • 5. cumulative incidence of relapse (CIR) [ Time Frame: 3 years ]
  • 6. cumulative incidence of death (CID) [ Time Frame: 3 years ]
  • 7. cumulative incidence of relapse event free survival (EFS) [ Time Frame: 3 years ]
  • 8. event free survival (EFS) [ Time Frame: 3 years ]
  • 9. Quality of Life (QLQ-C30) [ Time Frame: 3 years ]
  • 10. Incidence and intensity of adverse events (AEs) [ Time Frame: 3 years ]
Eligibility Criteria
  • Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

1. Patients with confirmed diagnosis of acute myeloid leukemia (AML) who are refractory*
to induction therapy and not eligible for further intensive induction therapy based on
documented medical reasons (e.g. disease characteristics or patient characteristics),
or

2. Patients with confirmed diagnosis of acute myeloid leukemia (AML) who are refractory*
to induction therapy and not immediate candidates for allogeneic HSCT (bridge to
transplant is allowed)

*refractory to induction therapy is defined as no CR, no CRi and no PR (according to
standard criteria, see Section 11.2.3) after at least one intensive induction therapy
including at least 5 days of cytarabine 100-200 mg/m² continuously or an equivalent
regimen with cytarabine with total dose not less than 500 mg/m² per cycle and at least
2 days of an anthracycline (e.g. daunorubicin, idarubicin).

3. Age ≥ 60; no upper age limit

4. ECOG performance status of ≤ 2 at screening

5. To control hyperleukocytosis or extramedullary involvement, medication with
hydroxyurea is allowed up to 24h before start of study treatment. In case of
hyperleukocytosis hydroxyurea should be given and start of study treatment should be
delayed until leukocyte counts are 2

5. Inadequate cardiac, hepatic and/or renal function at Screening Visit defined as:

1. heart failure NYHA II-IV

2. unstable angina pectoris

3. total bilirubin, ALT, AST > 2.5 x upper normal serum level

4. Creatinine > 1.5 x upper normal serum level

6. Active central nervous system involvement

7. Uncontrolled infection

8. Uncontrolled diabetes mellitus

9. Patients with a "currently active" second malignancy requiring active therapy other
than non-melanoma skin cancers (except for hormonal/antihormonal treatment, e.g. in
prostate or breast cancer)

10. Patients with "currently active" bladder cancer or bladder cancer in their history,
patients with risk factors for bladder cancer (e.g. exposure to aromatic amines or
heavy tobacco smoker), or macrohematuria of unknown origin

11. Severe neurological or psychiatric disorder interfering with ability of giving an
informed consent

12. Known or suspected active alcohol or drug abuse

13. Known positive for HIV, active HBV or HCV infection

14. No consent for registration, storage and processing of the individual disease
characteristics and course as well as information of the family physician and/or other
physicians involved in the treatment of the patient about study participation.

15. Treatment with any other clinical study drug within 14 days before the first
administration of the investigational drugs or at any time during the study

16. Breast feeding woman or women with a positive pregnancy test at Screening Visit

17. Male patients with a female partner of childbearing potential not willing to abstain
from sexual intercourse or to the use of at least two effective contraceptive methods
(e.g., synthetic condoms with spermicide, etc) at screening and throughout the course
of the study and for 3 months following the last study treatment.

Contacts and Locations
Contacts

Contact: Simone Thomas, PD Dr. +49-941-9440 simone.thomas@ukr.de

Locations

Germany
University Hospital Regensburg
Regensburg

Sponsors and Collaborators

University Hospital Regensburg

Anticancer Fund, Belgium

Celgene

Investigators

Principal Investigator: Simone Thomas, Dr. University Hospital Regensburg

More Information
  • Responsible Party: University Hospital Regensburg
  • ClinicalTrials.gov Identifier: NCT02942758 History of Changes
  • Other Study ID Numbers: AMLSG26-16
  • First Posted: October 24, 2016 Key Record Dates
  • Last Update Posted: October 11, 2018
  • Last Verified: October 2018
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No