Palbociclib Combination Therapy for Refractory Leukemia

Palo Alto (17 mi)

Overseen byTapan M Kadia

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase I trial studies the side effects and best dose of palbociclib when given alone and in combination with sorafenib, decitabine, or dexamethasone in treating patients with leukemia that has come back (recurrent) or that does not respond to previous treatment (refractory). Palbociclib, sorafenib, and decitabine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving palbociclib alone and in combination with sorafenib, decitabine, or dexamethasone may work better in treating patients with recurrent or refractory leukemia.

Eligibility Criteria

This trial is for adults with relapsed or refractory acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL), who have no standard treatment options left. They should not have received leukemia therapy in the last 14 days, must be physically stable with certain organ function levels maintained, and women of childbearing age need a negative pregnancy test and agree to use contraception.

Inclusion Criteria

My leukemia has returned or didn't respond to treatment, and no standard treatments are expected to work.

I can take care of myself but might not be able to do heavy physical work.

I have relapsed or refractory acute lymphoblastic leukemia.

Exclusion Criteria

I do not have active, uncontrolled leukemia in my brain or spinal cord.

I do not have any severe illnesses that could interfere with the study.

I do not have a history of serous retinopathy.

I have been treated with palbociclib before.

I am not pregnant or breastfeeding.

Treatment Details

The study is testing palbociclib alone and combined with sorafenib, decitabine, or dexamethasone to see which works best for stopping tumor growth in recurrent or resistant leukemia. It's looking at side effects and the best doses for these drugs.

3Treatment groups

Experimental Treatment

Group I: Arm III (palbociclib, dexamethasone)Experimental Treatment2 Interventions

Patients receive palbociclib as in Arm I. Patients also receive dexamethasone PO QD or IV over 15-30 minutes on days 1-4 and 15-18 beginning on cycle 2. Treatment repeats every 28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (palbociclib, decitabine)Experimental Treatment2 Interventions

Patients receive palbociclib as in Arm I. Beginning cycle 2, patients receive palbociclib PO QC on days 1-7 and decitabine IV QD over 1 hour on days 8-17 of cycle 2 and days 8-12 of cycles 3-8. Treatment repeats every 28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

Group III: Arm I (palbociclib, sorafenib)Experimental Treatment2 Interventions

Patients receive palbociclib PO QD on days 1-28. Patients also receive sorafenib PO QD on days 1-28 beginning on cycle 2. Treatment repeats every 28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

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

🇪🇺 Approved in European Union as Dacogen for: