EUCTR2018-003025-28-DEActive, not recruitingPhase 1
Phase-I/II trial for relapsed or refractory AML patients combining cytarabine and mitoxantrone with venetoclax - RELAX
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 54
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Signed Informed consent
- •AML according to WHO criteria, excluding APL
- •Relapsed after first or second CR, including relapse after allogeneic stem cell transplantation (dose escalation and expansion phase)
- •Only expansion phase: Primary refractory after 1-2 cycles of standard induction chemotherapy (100 to 200 mg/m2 cytarabine over 7-10 days plus anthracycline or mitoxantrone over 3 days) or equivalent treatment (e.g. CPX351)
- •Note: Primary refractory disease is defined by either = 20% myeloid blasts on early response assessment around day 15 after start of the most recent induction, or by = 5% myeloid blasts after blood count recovery after start of the most recent induction, respectively.
- •Age 18-75 years
- •Fit for intensive chemotherapy, defined by
- •- ECOG 0-2, life expectancy > 3 months
- •- Adequate hepatic function (ALAT/ASAT/Bilirubin =2.5 x ULN )
- •- Adequate renal function assessed by creatinine < 1.5 x ULN OR creatinine clearance (by Cockcroft Gault Formula) = 50 mL/min
- •Patient is afebrile and hemodynamically stable for at least 72 hours at the time of study medication initiation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 54
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 54
Exclusion Criteria
- •Acute promyelocytic leukemia
- •CNS involvement or subjects with extramedullary disease only
- •Known hypersensitivity to any agent given in association with this study including cytarabine or mitoxantrone
- •relapse within 90 days after last cytarabine dose
- •Intended hematopoietic stem cell transplantation planned as early conditioning from aplasia without previous blood count recovery
- •Cumulative previous exposure to anthracyclines of >410 mg/m2 doxorubicin equivalents
- •Acute GVHD = grade 2, extensive chronic GVHD or requiring systemic immunosuppressive therapy
- •HIV infection (due to potential drug-drug interactions between antiretroviral medications and venetoclax, as well as anticipated venetoclax mechanism based lymphopenia that may potentially increase the risk of opportunistic infections)
- •Inability to swallow oral medications
- •Any malabsorption condition
- •Cardiovascular disability status of New York Heart Association Class = 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or anginal pain.
- •Chronic respiratory disease that requires continuous oxygen use.
- •White blood cell count > 25 × 109/L. Note: Hydroxyurea is permitted to meet this criterion.
- •AML relapse treatment with any investigational or commercial drug within 10 days before enrolment. Hydroxyurea is allowed until enrolment to control peripheral WBC counts.
- •Substance abuse, medical, psychological, or social conditions that may interfere with the subject’s cooperation with the requirements of the trial or evaluation of the study results
- •Acute non-hematologic toxicities from any prior anti-leukemia therapy or from previous investigational drugs that have not resolved to Grade <2 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
- •History of active or chronic infectious hepatitis unless serology demonstrates clearance of infection (Occult or prior hepatitis B virus (HBV) infection (defined as negative hepatitis B surface antigen and positive total hepatitis B core antibody) may be included if HBV DNA is undetectable, provided that they are willing to undergo monthly DNA testing. Patients who have protective titers of hepatitis B surface antibody after vaccination or prior but cured hepatitis B are eligible. Patients positive for hepatitis C virus antibody are eligible provided PCR is negative for HCV RNA)
- •History of clinically significant liver cirrhosis (e.g., Child-Pugh class B and C).
- •Pregnant or breastfeeding patients
Investigators
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