A Dose Finding Study of IDH305 With Standard of Care in IDH1 Mutant Acute Myeloid Leukemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-26

Study Completion Date

2016-11-29

Brief Summary

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The purpose of this study is to evaluate the safety, tolerability and potential efficacy of IDH305 with standard treatments for newly diagnosed IDH1R132 mutant acute myeloid leukemia (AML).

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Detailed Description

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Conditions

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Acute Myeloid Leukemia (AML)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1: Medically fit for induction

IDH305 + Standard of care for patients that are medically fit for induction.

Group Type EXPERIMENTAL

IDH305

Intervention Type DRUG

Arm 2 Medically unfit for induction

IDH305 + Standard of care for patients that are medically unfit for induction.

Group Type EXPERIMENTAL

IDH305

Intervention Type DRUG

Interventions

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IDH305

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\-- Previously untreated AML. Patients with untreated, high or very high risk MDS (according to rIPSS or equivalent) are also permitted in Arm 2.

* Documentation of IDH1R132 mutation of tumor
* ECOG performance status ≤ 2
* Clinically fit for standard of care medication per protocol.

Exclusion Criteria

* Prior treatment for AML or MDS
* Any severe or uncontrolled medical conditions that would prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures such as the presence of other clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological disease.
* Acute Promyelocytic Leukemia
* Women who are pregnant or lactating

Other protocol-defined Inclusion/Exclusion may apply

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No