Status:
ACTIVE_NOT_RECRUITING
Pilot Study of CC 486 (Oral Azacitidine) Plus BSC as Maintenance After sc Azacitidine in Elderly HR-IPSS-R MDS Patients
Lead Sponsor:
University of Florence
Conditions:
MDS
CMML
Eligibility:
All Genders
65-100 years
Phase:
PHASE2
Brief Summary
Treatment of higher-risk (intermediate, high and very high) Myelodysplastic Syndromes (MDS) according to the revised International Prognostic Scoring System (IPSS-R) who obtained a stable hematologica...
Detailed Description
Azacitidine therapy is effective in prolonging survival in higher risk MDS patients provided therapy is administered at 28 day-cycles until progression or loss of response. A study conducted several ...
Eligibility Criteria
Inclusion
- Subjects must satisfy the following criteria to be enrolled in the study:
- Male or female subjects ≥ 65 years of age at the time of signing the ICD;
- Diagnosed, histologically confirmed at inclusion,
- Int-2 or High according to IPSS, or
- Very High, High or Intermediate according to IPSS-R, or
- Hypoplastic AML (20-30% BM blasts, previosuly considered MDS RAEB-T)
- myelodysplastic CMML (included in IPSS scoring, WBC \< 13.x 109/L);
- Should have undergone therapy with subcutaneous azacitidine for at least 4-6 cycles ( + 2 cycles)
- Must have achieved CR/CRi, PR or SD with HI status, as evidenced by IWG Criteria 2006 ( APPENDIX E):
- ECOG performance status of 0, 1, 2 (Appendix C);
- Adequate bone marrow function based on ANCs ≥ 1.0 x 109/L and platelet counts ≥ 70 x 109/L.
- Adequate organ function, defined as:
- Serum bilirubin ≤1.5 times the upper limit of normal (ULN); Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the ULN; Serum creatinine ≤ 2.5 times the ULN; 8.Male subjects with a female partner of childbearing potential must agree to practice abstinence or to the use of a physician-approved contraceptive method throughout the course of the study and avoid fathering a child during the course of the study and for 3 months following the last dose of azacitidine; 10. Understand and voluntarily sign an ICD prior to any study related assessments/procedures are conducted; 11. Able to adhere to the study visit schedule and other protocol requirements; 12. Ability to swallow study medication.
Exclusion
- Absence of confirmed hematological response ( IWG HI/PR/CR) after at least 4 to 6 months of azacitidine sc and maintenance of response for 2 additional cycles.
- Inability to provide a valid informed consent.
- Eligibility for HSCT
- Active infection
- Serum creatinine \> 2 x ULN at screening.
- ECOG performance status \> 2
- Left ventricular ejection fraction \< 50% by echocardiography
- A history of repeated hospitalization for severe infections Systemic diseases that would prevent study treatment (e.g. uncontrolled hypertension, cardiovascular, renal, hepatic, metabolic, etc.)
- Clinical or laboratory evidence of chronic Hepatitis B or Hepatitis C (definition of
- chronic hepatitis follows EASL 2017 criteria).
- History of HIV positive test result (ELISA or Western blot).
- ALT or AST over 3 times superior to ULN at screening.
- Total bilirubin over 1.5 times superior to ULN at screening (patients with Gilbert syndrome are allowed to enter the study)
- Patients participating in another clinical trial other than an observational registry study.
- Patients with a history of another malignancy within the past 3 years, with the exception of basal skin carcinoma or cervical carcinoma in situ or completely resected colonic polyps carcinoma in situ.
- History of non-compliance to medical regimens, or patients who are considered potentially unreliable and/or not cooperative.
- Presence of a surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drug.
- History of drug or alcohol abuse within the 12 months prior to enrollment.
Key Trial Info
Start Date :
March 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04806906
Start Date
March 24 2021
End Date
December 1 2024
Last Update
May 8 2024
Active Locations (1)
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1
AOU Careggi- University of Florence
Florence, Italy, 50134