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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
Must not have
Juvenile myelomonocytic leukemia (JMML)
Any other known bone marrow failure syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with juvenile myelomonocytic leukemia.
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I have a condition that affects my bone marrow's ability to produce blood cells.
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I am not pregnant.
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I have Fanconi anemia.
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I have another type of cancer at the same time.
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My cancer diagnosis is not listed among the excluded types.
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My leukemia developed from a previous blood disorder.
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My leukemia is Philadelphia chromosome positive.
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I have been diagnosed with acute promyelocytic leukemia.
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My leukemia is classified as biphenotypic or bilineal.
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I am a woman able to have children and have a negative pregnancy test.
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I am using effective birth control during the study.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Bortezomib Clearance
Change in Ejection Fraction
Change in Shortening Fraction
+12 more
Other study objectives
Course Duration
Incidence of Treatment-related Mortality
Length of Hospitalization
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
Sorafenib Tosylate
2005
Completed Phase 3
~4010
Mitoxantrone Hydrochloride
2016
Completed Phase 3
~650
Cytarabine
2016
Completed Phase 3
~3330
Etoposide
2010
Completed Phase 3
~2960
Daunorubicin Hydrochloride
2011
Completed Phase 3
~5330
Bortezomib
2005
Completed Phase 3
~1410
Asparaginase
2005
Completed Phase 4
~5220

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,920 Previous Clinical Trials
41,015,289 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
~114 spots leftby Nov 2025
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