EUCTR2015-001767-40-IT
Active, not recruiting
Phase 1
A phase II study testing the efficacy of combined azacitidine and lenalidomide for non-M3 acute myeloid leukemia (AML) patients aged between 60 and 70 years, fit, relapsed or refractory: the AZALEA study - AZALEA
AZIENDA OSPEDALIERA OSPEDALI RIUNITI MARCHE NORD0 sites66 target enrollmentSeptember 10, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ACUTE MYELOID LEUKEMIA
- Sponsor
- AZIENDA OSPEDALIERA OSPEDALI RIUNITI MARCHE NORD
- Enrollment
- 66
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of relapsed AML. A prior CR duration of at least 2 months is required to met the definition of relapsed AML. Patients must have not received more than 1 re\-induction course prior to enter the study.
- •Diagnosis of resistant AML. Patients must have received, at the upmost, 2 courses of therapy (first induction and first salvage course) before entering the study, in order to be eligible for enrolment.
- •Patients relapsing after stem cell transplantation, both autologous and allogeneic, are eligible.
- •HIV negativity.
- •Male and female patients aged \= 60 and \= 70 years.
- •Signed informed consent
- •Morphologically confirmed diagnosis of non\-M3 acute myeloid leukemia (AML) in first or subsequent relapse by bone marrow aspiration
- •WBC count \= 30,000/mm³. A pretreatment with single dose vinblastine in order to reduce the white blood cell count is allowed within 7 days from the start of therapy. Cytoreduction with hydroxyurea is not allowed.
- •Patient must be not eligible for or not interested in conventional salvage therapies.
- •Fertile male patients must use a condom during sexual contact with a pregnant female or a FCBP while taking lenalidomide, during dose interruptions and for at least 28 days after the last dose of lenalidomide, even if he has undergone a successful vasectomy.
Exclusion Criteria
- •Acute promyelocytic leukemia (FAB M3\)
- •Cytoreduction with hydroxyurea
- •Male and female patients aged \<60 years and \>70 years
- •Patients with resistant AML who have received more than 2 courses or more of reinduction chemotherapy
- •Blastic transformation of chronic myeloid leukemia
- •Absence of patient’s written informed consent
- •Active opportunistic infections
- •HIV infection
- •Active second malignancy
- •Intercurrent organ damage or medical problems that would interfere with therapy
Outcomes
Primary Outcomes
Not specified
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