Phase 2
N=1
Ruxolitinib Phosphate in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma · Untreated Chronic Lymphocytic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT03041636 ↗Enrolled (actual)
1
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Participants With a Clinical Response — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ruxolitinib (Drug); Ruxolitinib Phosphate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With a Clinical Response |
— | — |
| PRIMARY Number of Participants With Change of Tumor Burden |
— | — |
| PRIMARY Participants With a Response |
— | — |
| PRIMARY Time to Next Treatment |
— | — |
Summary
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.
Eligibility Criteria
Inclusion:
- Subjects who are able to understand and sign an informed consent document.
- Subjects 18 years of age or older.
- Subjects must be diagnosed with CLL/SLL and do not meet the IWCLL criteria for treatment
- Patients should be previously untreated or have only been treated with single agent ibrutinib therapy for a period of 2.5x Upper limit of normal (ULN). B) Modification of Diet in Renal Disease (MDRD) calculated GFR < 30 mL/min
- Subjects with active uncontrolled infection or who are HIV positive (Subjects with acute infections requiring treatment should delay screening/enrollment until the course of therapy has been completed and the event is considered controlled).
- Subjects with a history of or a current malignancy except for treated basal or squamous carcinomas of the skin completely resected.
- Subjects with clinically significant uncontrolled cardiac disease.
- Subjects being treated concurrently with any prohibited medications, including investigational medication, rifampin, St. John's wort, and potent CYP3A4 inhibitors (excluding ketoconazole) unless continuation of such medications are determined by the investigator to be in the best interest of the patient. Refer to protocol section 2.2.12 for more details.
- Subjects who have previously received JAK inhibitor therapy
- Subjects with active alcohol or drug addiction that would interfere with their ability to comply with the study requirements.
- Subjects with any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the subject or compliance with the protocol.
- Subjects who have unknown transfusion history.
- Patients who cannot comply with the study requirements.
Data sourced from ClinicalTrials.gov (NCT03041636). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.