AZD1775 in Advanced Acute Myeloid Leukemia, Myelodysplastic Syndrome and Myelofibrosis

Phase 2

Terminated

• Conditions: Myelofibroses; Acute Myeloid Leukemia; Myelodysplastic Syndromes
• Interventions: Drug: Combination AZD1775 with AraC; Drug: AZD1775 only

• Registration Number: NCT03718143
• Lead Sponsor: NYU Langone Health

Brief Summary

A phase II study testing the efficacy of combined AZD1775 with AraC or single agent activity of AZD1775 in three arms: Arm A has subjects age 60 years or older who are newly diagnosed with AML receiving the combination of the drugs; Arm B has subjects who are have relapsed/refractory AML and HMA failure MDS patients being allocated to either the combination Arm B or single agent AZD1775 Arm C.

Detailed Description

A phase II study testing the clinical efficacy of combined AZD1775 with AraC or single agent activity of AZD1775 in three patient strata: Elderly(\> 60 years) newly diagnosed AML patients (Arm A) will only receive the combination; whereas relapsed/refractory AML patients and HMA failure MDS patients will be allocated to either the combination (Arm B) or single agent AZD1775 (Arm C). The study will have a run in safety cohort of six patients in each of the three arms to determine the safe use of combined AraC /AZD1775 or single agent AZD1775 in the patient populations. This will be followed by an expansion phase of up to 20 and 21 eligible patients in each arm respectively where elderly patients with newly diagnosed AML will receive a combination of AZD1775 and AraC (Arm A) while patients with relapsed or refractory AML or HMA failure MDS will be allocated to receive either AZD1775 with AraC (Arm B) or AZD1775 alone (Arm C). An early toxicity check will be conducted to determine safety and tolerability. If indicated, dose levels will be reduced. The study will continue to enroll the rest of the patients at the tolerated dose.

Study Timeline

• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-22
• Study First Posted: 2018-10-24
• Study Start: 2019-05-08
• Primary Completion: 2019-09-27
• Study Completion: 2019-09-27
• Status Verified: 2020-05
• Results First Submitted: 2020-05-07
• Results First Submitted QC: 2020-05-20
• Last Update Submitted: 2020-05-20
• Results First Posted: 2020-06-02
• Last Update Posted: 2020-06-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: Elderly Newly diagnosed AML	Combination AZD1775 with AraC	Combination AZD1775 with AraC Elderly, newly diagnosed AML
Arm B:Relapsed AML and MDS	Combination AZD1775 with AraC	Combination AZD1775 with AraC Relapsed/Refractory AML \& HMA failure AML/ MDS
Arm C: Relapsed AML, MDS and MF	AZD1775 only	AZD1775 only Relapsed/Refractory AML \& HMA failure AML/ MDS and Relapsed/Refractory Primary \& Secondary MF

Primary Outcome Measures

Name	Time	Method
Complete Remission (CR) Rate	4 months	Less than 5% blasts in a non-hypocellular marrow with a granulocyte count ≥ 1.0, and a platelets count of ≥ 100 with complete resolution of extramedullary disease and absence of peripheral blood blasts.

Secondary Outcome Measures

Name	Time	Method
Complete Cytogenetic Remission (CCyR)	4 Months	The absence of chromosome abnormalities (if present at diagnosis) on conventional cytogenetic study using G-banding (at least 10 metaphases present).
Incomplete Measure of Complete Remission (CRi)	4 months	is called if patient meets all CR criteria except for residual neutropenia (ANC\<1 x109/L) or thrombocytopenia (platelets\<100 x109/L)

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States