Bortezomib + Sorafenib for Acute Myeloid Leukemia

Recruiting at232 trial locations

Overseen by Richard Aplenc

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies how well bortezomib and sorafenib tosylate work in treating patients with newly diagnosed acute myeloid leukemia. Bortezomib and sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib and sorafenib tosylate together with combination chemotherapy may be an effective treatment for acute myeloid leukemia.

Research Team

Richard Aplenc

Principal Investigator

Children's Oncology Group

Eligibility Criteria

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.

Inclusion Criteria

My physical condition does not limit my eligibility for this trial.

I've only had specific treatments like hydroxyurea or ATRA for my leukemia, and I've stopped them before starting this trial.

I've tried or cannot safely undergo a bone marrow test but can provide a blood sample with specific testing conditions.

Exclusion Criteria

I have been diagnosed with juvenile myelomonocytic leukemia.

I have a condition that affects my bone marrow's ability to produce blood cells.

I am not pregnant.

Treatment Details

Interventions

• Bortezomib (Proteasome Inhibitor)
• Sorafenib Tosylate (Tyrosine Kinase Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Arm D Experimental Treatment 7 Interventions

See Detailed Description. May reassigned to Arm C.

Group II: Arm C (Cohort 3) Experimental Treatment 10 Interventions

See Detailed Description. Different dose.

Group III: Arm C (Cohort 2) Experimental Treatment 10 Interventions

See Detailed Description.

Group IV: Arm C (Cohort 1) Experimental Treatment 10 Interventions

See Detailed Description

Group V: Arm B Experimental Treatment 10 Interventions

See Detailed Description

Group VI: Arm A Experimental Treatment 9 Interventions

See Detailed Description

Bortezomib is already approved in Canada, Japan for the following indications:

Approved in Canada as Velcade for:

• Multiple myeloma
• Mantle cell lymphoma

Approved in Japan as Velcade for:

• Multiple myeloma
• Mantle cell lymphoma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School