18 and older, any sex, with Myeloproliferative Diseases. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Participants With Objective ResponsePrimary· 3 cycles (28 days each) up to 3 months
To determine the efficacy of the combination of Ruxolitinib + Lenalidomide in patients with Myelofibrosis (MF). Objective response rate equals Complete and Partial Response, and Clinical Improvement as defined by International Working Group for Myelofibrosis Research and Treatment (IWG-MRT). Objective response rate (ORR), defined as a clinical improvement (CI), partial remission (PR), and complete remission (CR) according to the International Working Group (IWG) Criteria. Complete remission (CR): bone marrow blasts \<5%, hemoglobin \>/= 10, absolute neutrophil count (ANC) \>/= 1000, platelets
Group
Value
95% CI
Ruxolitinib + Lenalidomide
7
Adverse events — posted to ClinicalTrials.gov
Time frame: 6 years, 5 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Ruxolitinib + Lenalidomide
Serious: 19/31 (61%)
Deaths: 2/31
Serious adverse events (27 terms)
Reaction
System
Ruxolitinib + Lenalidomide
Lung Infection
Infections and infestations
—
Skin Infection
Infections and infestations
—
Fever
General disorders
—
Thromboembolic event
Vascular disorders
—
Neutropenic Fever
Infections and infestations
—
Anemia
Blood and lymphatic system disorders
—
Multi-Organ Failure
General disorders
—
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
—
Superior Vena Cava Syndrome
Vascular disorders
—
Chest pain
Cardiac disorders
—
Duodenal Infection
Infections and infestations
—
Myocardial Infarction
Cardiac disorders
—
Unspecified neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The goal of this clinical research study is to learn if the combination of ruxolitinib and lenalidomide can help to control MF. The safety of this study drug combination will also be studied.
Ruxolitinib is designed to stop certain proteins (called JAK1 and JAK2) that are found in MF cells from sending signals that may lead to the growth of cancer cells.
Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may decrease the growth of cancer cells.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07498205 — Comparing Momelotinib and Ruxolitinib in People With Untreated Myelofibrosis and Low Blood Cell Counts
· Phase 4
· not yet recruiting
NCT07249346 — Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease (
· Phase 2
· recruiting
NCT07311746 — Phase Ib/II Trial of Cladribine/Ruxolitinib/Venetoclax in Patients With Relapsed/Refractory T-cell Prolymphocytic Leukem
· Phase 1, PHASE2
· not yet recruiting
NCT07340138 — Study of Pelabresib add-on to Ruxolitinib in Japanese Adult Patients With Myelofibrosis
· Phase 1
· not yet recruiting
NCT07424222 — Ruxolitinib for Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (RISE)
· Phase 1
· not yet recruiting
Other M.D. Anderson Cancer Center trials
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
Last refreshed: 8 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01375140.