Status:
ACTIVE_NOT_RECRUITING
Venetoclax and Decitabine Assessment in Patients (≥60 - <75 Years) with Newly Diagnosed AML Eligible for Allo-SCT
Lead Sponsor:
Gruppo Italiano Trapianto di Midollo Osseo
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
60-75 years
Phase:
PHASE2
Brief Summary
This trial is a no profit, prospective, phase II, multicentre, non-randomised, uncontrolled, single group assignment, open label study to evaluate the safety and efficacy of the "chemo-free" combinati...
Detailed Description
This trial is a no profit, prospective, phase II, multicentre, non-randomised, uncontrolled, single group assignment, open label study to evaluate the proportion of elderly (≥60 - \<75 years) patients...
Eligibility Criteria
Inclusion
- • Patients \>60 \<75 years of age
- Diagnosis of AML eligible for allo-SCT from any donor
- High- and Intermediate-Risk ELN
- WBC \<25x109/L (Hydroxyurea is permitted to meet this criterion)
- adequate hepatic function (bilirubin ≤2 UNL; ALT/AST ≤2,5 UNL)
- adequate renal function (creatinine clearance ≥50 ml/min)
- ECOG Performance Status \< 2
- Males enrolled in the study with partners who are women of childbearing potential, must be willing to use an acceptable barrier contraceptive method during the trial.
- Women of childbearing potential must use highly effective contraception for at least 1 month after the last dose of VEN and for however long the EU SmPC says for DEC
- Willing and able to comply with all of the requirements and visits in the protocol.
- Written and signed informed consent.
Exclusion
- • Previous treatment for AML (Hydroxyurea is allowed) or for an antecedent Myelodysplastic Syndrome (MDS).
- Absence of informed consent
- AML patients with t(15;17); t(8;21); inv(16)
- Subject has known active CNS involvement with AML.
- Low Risk ELN
- grade \>2 NCI-CTCAE (v. 5) adverse events at the time of enrollment
- Serious organ dysfunction: left ventricular ejection fraction \< 40%, FEV1, FVC, DLCO (diffusion capacity) \<40% of predicted, LFT \> 5 times the upper limit of normal, or creatinine clearance \< 40 ml/min.
- The evidence of HBV or HCV active infection (HBV DNA HCV RNA positive test).
- Patients with HIV infection
- Current uncontrolled infections
- Patients with other life-threatening concurrent disease
- Subjects with known hypersensitivity to any of the component medication
- Subject has a history of other malignancies within 2 years prior to study entry, with the exception of:
- Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;
- Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
- Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent. • Participation in another clinical trial within 1 month before the start of this trial
Key Trial Info
Start Date :
December 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04476199
Start Date
December 9 2019
End Date
June 30 2025
Last Update
January 6 2025
Active Locations (25)
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1
USD, Trapianti di Midollo osseo, Azienda Spedali Civili di Brescia
Brescia, Brescia, Italy, 25100
2
Unità Terapia Intensiva Ematologica e terapia cellulari - casa della sofferenza
San Giovanni Rotondo, Foggia, Italy, 71100
3
UO Ematologia e TMO - Ospedale C. Panico
Tricase, Lecce, Italy
4
Ospedale San Gerardo
Monza, Monza, Italy, 20900