Experimental combo offers hope for Tough-to-Treat leukemias
NCT ID NCT03132454
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a drug called palbociclib, given alone or with other medicines, in people whose leukemia has returned or stopped responding to standard treatments. The main goal is to find the safest dose and understand side effects. About 32 adults with acute myeloid or lymphoblastic leukemia will take part.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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32 people
The number who actually took part.
- Started
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Jul 2017
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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15 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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. 2. Only participants with R/R ALL will be eligible for cohort C 3. Age \>/= 15 years. 4. 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. 5. Adequate organ function as defined below: * liver function (bilirubin \< 2mg/dL, AST and/or ALT \<3 x ULN - or \<5 x ULN if related to leukemic involvement) * kidney function (creatinine \< 1.5 x ULN ). * known cardiac ejection fraction of \> or = 45% within the past 3 months 6. ECOG performance status of ≤ 2. 7. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial. 8. 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: 1. Participants women are excluded from this study because the agent used in this study has the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided. 2. Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 3. Participant with documented hypersensitivity to any of the components of the therapy program. 4. Participants with active, uncontrolled CNS leukemia will not be eligible. 5. Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation. 6. Participants with known history of serous retinopathy will not be eligible. 7. Prior treatment with palbociclib,
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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