Can a cancer drug slow down a rare leukemia?
NCT ID NCT03722407
First seen Jun 25, 2026 · Last updated Jul 02, 2026 · Updated 4 times
Summary
This study tests the drug ruxolitinib (Jakafi) in 29 people with chronic myelomonocytic leukemia (CMML), a rare blood cancer. The goal is to see if the drug can improve blood counts, shrink the cancer, or delay its turning into a more aggressive leukemia. Researchers are also checking how safe the drug is and how long any benefits last.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ruxolitinib (also known as Jakafi)
- What this could lead to
- If successful, this could offer a new treatment option to control CMML and delay its progression to acute leukemia.
- What could go wrong
- This is a small, early-phase trial with only 29 participants, so results may not apply broadly. The drug may not work or could cause side effects.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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29 people
The number who actually took part.
- Started
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Aug 2019
- Expected to finish
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May 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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18 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: * Confirmed diagnosis of Chronic Myelomonocytic Leukemia (CMML)using the World Health Organization (WHO) classification. * 18 years of age or older at the time of obtaining informed consent. * Must be able to adhere to the study visit schedule and other protocol requirements. * Participants must be able to provide adequate BM aspirate and biopsy specimens for histopathological analysis and standard cytogenetic analysis during the screening procedure. * An Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 is required. * Women of childbearing potential must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. * Must understand and voluntarily sign an informed consent form. * Must have a life expectancy of greater than 3 months at time of screening. * Must have symptomatic splenomegaly and/or an Myeloproliferative Neoplasms Symptom Assessment Form Total Symptom Score \>17. Exclusion Criteria: * Any of the following lab abnormalities: Platelet count of less than 35,000/uL, Absolute Neutrophil Count (ANC) less than 250/uL, Serum Creatinine ≥ 2.0, Serum total bilirubin \>1.5x ULN * Use of cytotoxic chemotherapeutic agents, or experimental agents (agents that are not commercially available) for the treatment of CMML within 28 days of the first day of study drug treatment. * Prior history of metastatic malignancy in past 2 years * Any serious medical condition or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he/she participates in the study. * Concurrent use of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF). Granulocyte Colony Stimulating Factor (G-CSF) could be used for the short-term management of neutropenic infection. Stable doses of erythropoietin stimulating agents that were started \>8 weeks from first ruxolitinib dose or corticosteroids that were being administered prior to screening are allowed. * Uncontrolled current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study because ruxolitinib has not been studied in pregnant participants. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ruxolitinib, breastfeeding should be discontinued if the mother is treated with ruxolitinib.
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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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Cleveland Clinic
Cleveland, Ohio, 44195, United States
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Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
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Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231, United States
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Weill Medical College of Cornell University
New York, New York, 10021, United States
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