NCT03722407 · REGISTRY CONDITION SEARCH

Ruxolitinib for the Treatment of Chronic Myelomonocytic Leukemia (CMML): A Phase 2 Expansion

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: ACTIVE NOT RECRUITING
Registry last update: 2026-07-01

This study is to find out if treating Chronic Myelomonocytic Leukemia (CMML) with a study drug (ruxolitinib) can improve outcomes of patients with CMML.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Response

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outcome · POSTED

Time to Acute Myeloid Leukemia (AML) Transformation

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outcome · POSTED

Overall Survival

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outcome · POSTED

Duration of Response

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
All patients will be given their first dose of oral Ruxolitinib, 20 mg at first scheduled visit. After that dose and on all other days patients will self-administer oral Ruxolitinib at a dose of 40 mg daily divided into two equal doses approximately 12 hours apart. Patients will be treated for a total of 16 weeks. After treatment, patients will be followed monthly.
intervention Names
Drug: Ruxolitinib
label
Ruxolitinib
type
EXPERIMENTAL

interventions

arm Group Labels
Ruxolitinib
description
Ruxolitinib 5 mg tablets, 4 per dose
name
Ruxolitinib
other Names
Jakafi
type
DRUG

Study design

allocation

intervention Model

SEQUENTIAL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 29
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Number of participants achieving clinical benefit defined as hematologic improvement, complete remission, partial remission, or stable disease by the International Working Group Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) Criteria.
measure
Overall Response
time Frame
At week 16

secondary Outcomes

description
Time to AML transformation according to World Health Organization (WHO) Critieria
measure
Time to Acute Myeloid Leukemia (AML) Transformation
time Frame
Every 6 months after conclusion of treatment until end of study (40.3 months)
description
Overall survival will be from first dose of study drug until failure or death from any cause.
measure
Overall Survival
time Frame
Up to 2 years
description
Duration of response measured using time to AML transformation according to WHO Critieria
measure
Duration of Response
time Frame
Up to 2 years

Full study description

brief Summary: This study is to find out if treating Chronic Myelomonocytic Leukemia (CMML) with a study drug (ruxolitinib) can improve outcomes of patients with CMML.

Source references