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Volasertib + Decitabine in Patients With Acute Myeloid Leukemia (AML) | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Volasertib + Decitabine in Patients With Acute Myeloid Leukemia (AML)

An Open Label, Phase I, Dose Escalation Trial to Investigate the Maximum Tolerated Dose, Safety, Pharmacokinetics, and Efficacy of Volasertib in Combination With Decitabine in Patients >= 65 Years With Acute Myeloid Leukemia

NCT02003573•Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

Dose Escalation (MTD Finding) Phase: To investigate the maximum tolerated dose (MTD), safety and pharmacokinetics of different volasertib administration schedules in combination with decitabine in previously untreated AML patients \>= 65 years of age who are considered ineligible for standard intensive therapy, or patients with relapsed or refractory AML regardless of prior treatment status. MTD Extension Phase: To collect additional data on safety, efficacy and pharmacokinetics of volasertib in combination with decitabine in previously untreated patients with AML \>= 65 years of age and considered ineligible for standard intensive therapy.

Eligibility

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Dose Escalation Phase: patients with previously untreated AML, relapsed or refractory AML regardless of prior treatment status.
•2. MTD Extension Phase: previously untreated AML (prior treatment for Myelodysplastic Syndrome(MDS) is allowed).
•3. Age \>= 65 years.
•4. Previously untreated patients must be ineligible for receiving standard intensive therapy at the time of enrolment, in the opinion of the investigator and based on documented medical reasons.
•5. Histologically or cytologically confirmed AML (except for APL, FAB (French-American-British)subtype M3) according to the World Health Organisation classification.
•6. Eastern co-operative oncology group (ECOG) performance score =\< 1 at screening.
•7. Signed and dated written informed consent by start date of Screening Visit in accordance with Good Clinical Practice and local legislation.

Exclusion Criteria

•1. MTD Extension Phase: Prior chemotherapy for AML (except for hydroxyurea). Patients can receive treatment with hydroxyurea in order to reduce high White Blood Cells count for no more than 28 days (cumulative); discontinuation of hydroxyurea at least one day prior to the study treatment is required. Please note that any prior therapy for MDS is allowed.
•2. Acute promyelocytic leukemia (APL, FAB subtype M3), according to World Health Organisation classification.
•3. Hypersensitivity to the trial drugs.
•4. Other malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment, e.g. in prostate or breast cancer).
•5. Known clinical central nervous system (CNS) symptoms deemed by the investigator to be related to leukemic CNS involvement.
•6. QTcF (QT interval corrected for heart rate by the Fridericia formula) \> 470 ms, calculated as the mean value of the triplicates taken at least 2 minutes apart at baseline or QTcF prolongation deemed clinically relevant by the investigator.
•7. Baseline Left Ventricular Ejection Fraction of \< 45% or below the lower limit of institutional normal range.
•8. Aspartate amino transferase (AST) or alanine amino transferase (ALT) \> 2.5 x the upper limit of normal (ULN). Patients with elevated liver enzyme(s) due to leukemic involvement are allowed up to = 5 x the ULN.
•9. Total bilirubin \> 1.5 x ULN. For patients with Gilbert's syndrome or elevation due to hepatic infiltrate, total bilirubin must be \<4 x ULN.
•10. Creatinine clearance (CLcr) \< 30 ml/min (estimated creatinine clearance by the Cockcroft-Gault (C-G) equation.
+10 more criteria

Locations (3)

Yale Cancer Center

New Haven, Connecticut, United States

Washington School of Medicine

St Louis, Missouri, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

January 29, 2014

Primary Completion Date

January 6, 2015

Completion Date

May 15, 2016

Last Updated

January 31, 2019

Enrollment

ACTUAL participants

Conditions

Leukemia, Myeloid, Acute

Interventions

decitabine iv

DRUG

volasertib iv infusion

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 31, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Volasertib + Decitabine in Patients With Acute Myeloid Leukemia (AML)

Inclusion Criteria

Exclusion Criteria

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