Active — Not RecruitingPhase 1

Palbociclib and Sorafenib, Decitabine, or Dexamethasone in Treating Patients With Recurrent or Refractory Leukemia

United States32 participantsStarted 2017-07-25

Plain-language summary

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.

Who can participate

Age range15 Years

SexALL

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Inclusion criteria

✓. Participants with a diagnosis of histologically confirmed relapsed or refractory (R/R) acute myeloid leukemia or R/R acute lymphoblastic leukemia for which no available standard therapies are indicated or anticipated to result in a durable response.
✓. Only participants with R/R ALL will be eligible for cohort C
✓. Age \>/= 15 years.
✓. Participants must not have had leukemia therapy for 14 days prior to starting palbociclib. However, participants with rapidly proliferative disease may receive hydroxyurea as needed until 24 hours prior to starting therapy on this protocol and starting the first cycle of study.
✓. Adequate organ function as defined below:
✓. ECOG performance status of ≤ 2.
✓. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.
✓. Participants must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the participants or his legally authorized representative is required prior to their enrollment on the protocol.

Exclusion criteria

What they're measuring

Maximum tolerated dose (MTD) as determined by dose limiting toxicity (DLT)

Timeframe: Up to cycle 2 (each cycle is 28 days)

Trial details

NCT IDNCT03132454

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

View on ClinicalTrials.gov More Recurrent Acute Lymphoblastic Leukemia trials