Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase 1/1b Open-Label Study to Determine the Safety and Tolerability of ALRN-6924 Alone and in Combination With Cytarabine (Ara-C) in Patients With Relapsed/Refractory Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome With Wild-Type TP53
Verified date | November 2019 |
Source | Aileron Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Phase 1/1b, open label, multi-center dose escalation and dose expansion study designed to evaluate safety, tolerability, PK (pharmacokinetics), PD (pharmacodynamics) and anti-tumor effects of ALRN-6924 alone or in combination with cytarabine in patients with relapsed/refractory acute myeloid leukemia or advanced myelodysplastic syndrome with wild-type (WT) TP53
Status | Completed |
Enrollment | 55 |
Est. completion date | August 2019 |
Est. primary completion date | April 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Relapsed or refractory acute myeloid leukemia or IPSS-R intermediate/high/very high-risk MDS patients - Confirmed or anticipated wild-type TP53 - ECOG (Eastern Cooperative Oncology Group) performance status 0-2 - Adequate hepatic and renal function - Acceptable coagulation function - Negative serum or urine pregnancy test within 7 days prior to the first dose of ALRN-6924 for women of child-bearing potential - Sufficient wash out from prior therapies and recovery from all significant toxicities Exclusion Criteria: - Patients are eligible for available approved standard therapies - Prior treatment with MDM2 inhibitor, with protocol specified exceptions - Patients with history of allogeneic stem cell transplantation - Leukemic blast counts of >25,000/µl - Deletion of chromosome 17, or del(17p) - Patients with evidence of current central nervous system leukemic involvement - Known hypersensitivity to any study drug component - History of coagulopathy - Prior specified cardiovascular risk factors - Clinically significant gastrointestinal bleeding within 6 months - Clinically significant third-space fluid accumulation - Pregnant or lactating females - Evidence of any serious and/or unstable pre-existing medical condition that would interfere with patient safety ability to provide informed consent - Active uncontrolled infection, including HIV/AIDS or Hepatitis B or C - Second malignancy within one year, with protocol specified exceptions |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Aileron Therapeutics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate the safety and tolerability of ALRN-6924 alone and in combination with cytarabine | Number of participants with treatment-related adverse events as assessed by CTCAE v.4.0 | From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle is 28 days) | |
Primary | Determine maximum tolerated dose (MTD) | Determine the dose limiting toxicities (DLT) and the maximum tolerated dose (MTD) or the optimal biological dose (OBD) of ALRN-6924 in adult patients with AML or MDS | From the first dose until the end of Cycle 2 (each cycle is 28 days) | |
Secondary | Determine PK parameters of ALRN-6924 when administered to patients with acute myeloid leukemia (AML) or advanced myelodysplastic syndrome (MDS) | Peak Plasma Concentration (Cmax) | First 2 cycles (each cycle is 28 days) | |
Secondary | Determine PK parameters of ALRN-6924 when administered to patients with acute myeloid leukemia (AML) or advanced myelodysplastic syndrome (MDS) | Area under the plasma concentration versus time curve [AUC] | First 2 cycles (each cycle is 28 days) | |
Secondary | Determine immunogenicity of ALRN-6924 | Incidence of anti-ALRN-6924 antibodies | Approximately 16 weeks | |
Secondary | Determine best overall response, duration of response, morphologic leukemia-free state, leukemia free survival, percentage of MDA patients who have achieved hematologic improvement, changes in transfusion rate and early death rate | International Working Group (IWG) Criteria (Cheson et al, 2006) | Approximately 16 weeks | |
Secondary | Determine best overall response, duration of response, morphologic leukemia-free state, leukemia free survival, percentage of MDA patients who have achieved hematologic improvement, changes in transfusion rate and early death rate | AML response criteria (Dohner et al, 2010) | Approximately 16 weeks | |
Secondary | Determine best overall response, duration of response, morphologic leukemia-free state, leukemia free survival, percentage of MDA patients who have achieved hematologic improvement, changes in transfusion rate and early death rate | International Working Group (IWG) Criteria for hematological improvement in MDS (Cheson et al, 2000) | Approximately 16 weeks |
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