Ruxolitinib in the Treatment of Chronic Lymphocytic Leukemia

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if Ruxolitinib, an inhibitor of cytokine-signaling, is effective in the treatment of patients with Chronic Lymphocytic Leukemia for whom conventional chemotherapy is either too toxic or ineffective.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunnybrook Health Sciences Centre
• Collaborator: Novartis

Criteria

Inclusion Criteria:

1. Age greater than 65 years unless a 17p deletion is present in more than 20% of circulating tumor cells, in which case age can be younger than 65 years.

2. Diagnosis of CLL meeting published diagnostic criteria.

3. CLL requiring treatment on the basis of National Cancer Institute (NCI) working group criteria.

4. Not previously treated with cytotoxic drugs or antibodies but may have received glucocorticoid monotherapy, local radiation, or splenectomy.

5. Unfit for full dose FCR chemotherapy.

6. Platelets >50x10**9/L. Neutrophils>.75x10**9/L.

7. At least 1 lymph node >1.5 cm or splenomegaly as detected by CT scan.

Exclusion Criteria:

1. Fit for full-dose FCR as initial treatment.

2. Progressive multifocal leukoencephalopathy (PML).

3. Clinically significant bacterial, fungal, parasitic or viral infection, which require therapy.

4. Richter's transformation or prolymphocytic leukemia.

5. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura.

6. Prior exposure to chemotherapy for CLL with the exception of glucocorticoids, local radiation, or splenectomy.

7. History of prior malignancy, with the exception of the following: i. Malignancy treated with curative intent and with no evidence of active disease for more than 2 years. ii. Adequately treated skin cancer. iii. Adequately treated cervical carcinoma in situ.

8. Currently active clinically significant cardiovascular disease.

9. History of stroke or intracranial hemorrhage within 6 months prior to enrollment.

10. Renal failure requiring dialysis and patients with moderate and severe renal impairment with platelet counts less than 100,000/ml.

11. Hepatic impairment.