A Phase 1/2, Open-label Study of Valemetostat in Combination With Rituximab and Lenalidomide in Relapsed or Refractory Follicular Lymphoma
Part of paid clinical trials in Houston, Texas.
- Sponsor
- M.D. Anderson Cancer Center
- Study ID
- NCT05683171
- Phase
- PHASE1/PHASE2
- Status
- Active Not Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Rituximab — DRUGGiven by IV (vein)
- Lenalidomide — DRUGGiven by PO
- Valemetostat — DRUGGiven by PO
Study Details
To find a recommended dose of valemetostat that can be given in combination with rituximab and lenalidomide to patients with follicular lymphoma. The safety and effects of this drug combination will also be studied
Key Dates
- First listed
- Jan 13, 2023
- Start date
- May 19, 2023
- Status verified
- Jun 2026
- Primary completion
- Sep 30, 2027
- Completion
- Sep 30, 2027
Study Design
- Enrollment
- 16 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Phase 1 Dose EscalationThe dose escalation phase will assess the safety/tolerability of escalating doses of valemetostat and lenalidomide when combined with rituximab
Primary Outcome Measure
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: through study completion; an average of 1 year. ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | - |
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