Nintedanib + Azacitidine for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

Overseen byJessica Altman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Northwestern University

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to find the appropriate dose of the study drug nintedanib when combined with azacitidine and the associated side effects of the combination in older adults with AML characterized by HOX gene overexpression who are not interested in or not considered fit for standard intensive chemotherapy. The use of the study drug nintedanib in this study is investigational. Investigational means that this medication has not yet been approved by the FDA to treat this type of cancer. Azacitidine received FDA Approval in 2004 for myelodysplastic syndrome (a blood cancer related to AML) and has a National Comprehensive Cancer Network (NCCN) guideline recommendation for treatment of older adults who are not candidates for or decline intensive remission induction therapy. We expect participation to continue in this study based on each participant's response to the drug, and ability to tolerate treatment. Participants may continue to receive study treatments for 6 cycles (one cycle is 28 days long). If the 6 cycles of treatment is completed, participants may be moved on to a maintenance phase of treatment. Treatment will continue until the participant's leukemia gets worse, or they experience serious side effects, have a break in treatment for more than 56 days or the study doctor feels it is best for study treatments to stop.

Eligibility Criteria

This trial is for adults with Acute Myeloid Leukemia (AML) showing HOX gene overexpression, FLT3-ITD, or specific genetic changes. Suitable candidates are those unfit for intensive chemotherapy, have an ECOG performance status of 0-3, and acceptable organ function tests. Women must not be pregnant and participants should agree to use contraception.

Inclusion Criteria

Total bilirubin ? 1.5 x of institutional ULN within14 days prior to registration

Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SPGT]) 1.5 X institutional upper limit of normal (ULN) within14 days prior to registration

NOTE: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

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Exclusion Criteria

Exceptions for prior treatments are:

Patients with hypersensitivity to mannitol are not eligible; patients who have known hypersensitivity to peanut or soya, any other trial drug, or their excipients, or to contrast media are not eligible

I do not have active hepatitis, HIV, or a history of substance abuse.

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Participant Groups

The study is testing the combination of Nintedanib (not yet FDA-approved for AML) with Azacitidine (approved for a related blood cancer). The goal is to determine the right dose and side effects over six 28-day cycles, possibly followed by maintenance treatment unless adverse events occur.

1Treatment groups

Experimental Treatment

Group I: Treatment (nintedanib, azacitidine)Experimental Treatment3 Interventions

Participants receive nintedanib PO BID on days 1-28 and azacitidine IV or SC on days 1-7. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, participants may discontinue treatment, receive nintedanib every 4-8 weeks, or receive nintedanib and azacitidine every 4-8 weeks.

Azacitidine is already approved in European Union, United States, Canada, Japan, Australia for the following indications:

🇪🇺 Approved in European Union as Vidaza for: