Ibrutinib and Lenalidomide in Treating Patients With Myelodysplastic Syndrome
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Myelodysplastic Syndrome
- Previously Treated Myelodysplastic Syndrome
- Refractory High Risk Myelodysplastic Syndrome
- Secondary Myelodysplastic Syndrome
- Therapy-Related Myelodysplastic Syndrome
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: To determine the recommended Phase II dose (RP2D) for ibrutinib in combination with lenalidomide in patients with myelodysplastic syndrome (MDS). SECONDARY OBJECTIVES: To do an early assessment of the activity of the combination of ibrutinib and lenalidomide in patients with MDS....
PRIMARY OBJECTIVES: To determine the recommended Phase II dose (RP2D) for ibrutinib in combination with lenalidomide in patients with myelodysplastic syndrome (MDS). SECONDARY OBJECTIVES: To do an early assessment of the activity of the combination of ibrutinib and lenalidomide in patients with MDS. TERTIARY OBJECTIVES: To examine the pharmacodynamic and biological effects of the combination of ibrutinib and lenalidomide in MDS.
Tracking Information
- NCT #
- NCT03359460
- Collaborators
- Pharmacyclics LLC.
- Celgene
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Brian Jonas University of California, Davis
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