18 and older, any sex, with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Untreated Chronic Lymphocytic Leukemia. 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 a Clinical ResponsePrimary· Up to 6 months after initiation of therapy
Clinical response will be assessed based on physical examination, complete blood count (CBC), a bone marrow aspiration, a whole body CT scan to be done at screening and 6 + 2 months in accordance with the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines (Hallek et al., 2008)
Group
Value
95% CI
Treatment (Ruxolitinib Phosphate)
0
Number of Participants With Change of Tumor BurdenPrimary· 6 months after initiation of therapy
Tumor burden will be assessed by bone marrow aspiration, whole body CT scan at screening and 6 months.
Group
Value
95% CI
Treatment (Ruxolitinib Phosphate)
0
Participants With a ResponsePrimary· Up to 30 days
Response Rate is Complete Response (CR) or Partial Response (PR). CR is absence of Lymphadenopathy, Hepatomegaly or Splenomegaly, lymphocytes \< 4000/ul, normocellular, \<30% lymphocytes, no B-lymphoid nodules, Platelets \> 100,000/ul, hemoglobin \>11.0 g/dl and Neutrophils \>1500/ul.
PR is \>/= 50% decrease in lymphadenopathy, hepatomegaly, splenomegaly and Blood Lymphocytes from baseline, 50% reduction in marrow infiltrate or B-lymphoid nodules. Platelet count \> 100,000/ul, Hemoglobin \> 11 g/dl and Neutrophils \>1500/ul or increase \>/= 50% of all over base.
Group
Value
95% CI
Treatment (Ruxolitinib Phosphate)
0
Time to Next TreatmentPrimary· Up to 30 days
Number of months to subsequent therapy per patient.
Group
Value
95% CI
Treatment (Ruxolitinib Phosphate)
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 3 years.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase II trial studies how well ruxolitinib phosphate works in treating patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma. Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Publications & conference data
3 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 recruiting trials for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Currently open trials in the same condition.
NCT06859008 — Zanubrutinib in Combination With Sonrotoclax for the Treatment of Underrepresented Ethnic and Racial Minorities With Rel
· Phase 1
· recruiting
NCT06978088 — LP-168 and Obinutuzumab for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and Variants of This
· Phase 2
· recruiting
NCT06757647 — Acalabrutinib for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
· Phase 2
· recruiting
NCT05643235 — Implanted Loop Recorders for Detection and Management of Arrhythmia With Bruton Tyrosine Kinase Inhibitors
· NA
· recruiting
NCT05294731 — Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Deg
· Phase 1, PHASE2
· recruiting
Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem
· Phase 1, PHASE2
· not yet recruiting
NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and
· Phase 1
· not yet recruiting
NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che
· Phase 2
· not yet recruiting
NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca
· Phase 2
· not yet recruiting
NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar
· Phase 1
· not yet recruiting
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: 21 April 2021
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/NCT03041636.