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Proteasome Inhibitor

Bortezomib + Sorafenib for Acute Myeloid Leukemia

Phase 3

Waitlist Available

Led By Richard Aplenc

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Biopsy proven isolated myeloid sarcoma (myeloblastoma; chloroma, including leukemia cutis)

Patients with previously untreated primary AML who meet the customary criteria for AML with >= 20% bone marrow blasts as set out in the 2008 World Health Organization (WHO) Myeloid Neoplasm Classification are eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial looks at a new combination therapy for acute myeloid leukemia, which may be more effective than current treatments.

Who is the study for?

This trial is for patients newly diagnosed with acute myeloid leukemia (AML) who haven't had any previous antileukemic therapy, except hydroxyurea, ATRA, corticosteroids, or IT cytarabine at diagnosis. Eligible participants include those with >=20% bone marrow blasts or certain genetic abnormalities characteristic of AML. Pregnant or breastfeeding women and individuals with other malignancies or specific syndromes are excluded.Check my eligibility

What is being tested?

The study tests the effectiveness of bortezomib and sorafenib tosylate combined with chemotherapy in treating new cases of AML. It aims to see if these drugs can stop cancer growth by inhibiting enzymes needed for cell division. The trial includes a pharmacological study and assessments of quality-of-life impacts.See study design

What are the potential side effects?

Potential side effects may include reactions related to organ inflammation due to enzyme inhibition, typical chemotherapy-related issues such as nausea, fatigue, hair loss, increased risk of infection and bleeding disorders due to low blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a confirmed diagnosis of myeloid sarcoma.

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I have AML with more than 20% bone marrow blasts, as per WHO guidelines.

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My AML has specific genetic changes.

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I have been recently diagnosed with acute myelogenous leukemia for the first time.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

EFS for Patients on Arm C, Cohort 1

EFS for Patients on Arm C, Cohort 2

EFS for Patients on Arm C, Cohort 3

+1 more

Secondary outcome measures

Bortezomib Clearance

Change in Ejection Fraction

Change in Shortening Fraction

+12 more

Other outcome measures

Course Duration

Incidence of Treatment-related Mortality

Length of Hospitalization

+3 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: Arm DExperimental Treatment7 Interventions

See Detailed Description. May reassigned to Arm C.

Group II: Arm C (Cohort 3)Experimental Treatment10 Interventions

See Detailed Description. Different dose.

Group III: Arm C (Cohort 2)Experimental Treatment10 Interventions

See Detailed Description.

Group IV: Arm C (Cohort 1)Experimental Treatment10 Interventions

See Detailed Description

Group V: Arm BExperimental Treatment10 Interventions

See Detailed Description

Group VI: Arm AExperimental Treatment9 Interventions

See Detailed Description

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mitoxantrone Hydrochloride

2016

Completed Phase 3

~650

Etoposide

2010

Completed Phase 3

~2440

Cytarabine

2016

Completed Phase 3

~3310

Sorafenib Tosylate

2005

Completed Phase 3

~4010

Daunorubicin Hydrochloride

2011

Completed Phase 3

~5070

Bortezomib

2005

Completed Phase 2

~1140

Asparaginase

2005

Completed Phase 4

~5000

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,931,508 Total Patients Enrolled

Richard AplencPrincipal InvestigatorChildren's Oncology Group

3 Previous Clinical Trials

590 Total Patients Enrolled

Media Library

Bortezomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01371981 — Phase 3

Acute Myeloid Leukemia Research Study Groups: Arm C (Cohort 3), Arm D, Arm C (Cohort 2), Arm A, Arm B, Arm C (Cohort 1)

Acute Myeloid Leukemia Clinical Trial 2023: Bortezomib Highlights & Side Effects. Trial Name: NCT01371981 — Phase 3

Bortezomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01371981 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other similar studies that have used Arm C (Cohort 2)?

"Arm C (Cohort 2) was first studied in the year 1997 at City of Hope Comprehensive Cancer Center. So far, there have been 2541 completed trials. There are 815 active clinical trials at the moment, and a large quantity of these are taking place in Cincinnati, Ohio."

Answered by AI

If this research is successful, how many areas could it potentially expand to?

"This clinical trial is enrolling patients at major children's hospitals in Ohio, Indiana, and Texas. Additionally, there are 100 other sites where patients can enroll in the trial."

Answered by AI

What are the goals that this group of test subjects are hoping to achieve?

"This study's primary objective is to assess the event-free survival (EFS) for patients on Arm C, Cohort 1 over the course of 3 years. Secondary objectives include estimating the 3-year overall survival (OS) rate for patients on Arm C, Cohort 2 and Arm C, Cohort 3 using the Kaplan-Meier method, as well as measuring the relapse rate for patients without high allelic ratio FLT3/ITD+ mutations."

Answered by AI

How many people fit the eligibility requirements for this experiment?

"This particular trial is not taking new patients at the moment, however, there are 1588 other clinical trials for granulocytic sarcoma and 815 for Arm C (Cohort 2) that are."

Answered by AI

Could you explain the typical purpose of Arm C (Cohort 2)?

"Arm C (Cohort 2) is a common treatment plan for small cell lung cancer patients. However, it has also been effective in treating leukemia, myelocytic, acute, lymphoma, and neuroblastoma (nb)."

Answered by AI

Are there any patients needed for this clinical trial at the moment?

"This study is not presently looking for patients to enroll. The clinical trial was originally posted on 6/20/2011 and was most recently edited on 9/16/2022. If you are seeking other studies, there are presently 1588 clinical trials actively enrolling patients with granulocytic sarcoma and 815 studies for Arm C (Cohort 2) actively looking for participants."

Answered by AI