Trials / Completed
CompletedNCT01994382
Phase 1/2a Dose Escalation Study in Participants With CLL, SLL, or NHL
A Phase 1/2a Open-Label, Multi-Dose, Multi-Center Escalation and Exploratory Study of Cerdulatinib (PRT062070) in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) or B-Cell or T-Cell Non-Hodgkin Lymphoma (NHL)
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 260 (actual)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will identify the highest dose, and assess the safety, of cerdulatinib (PRT062070) that may be given in participants with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma or non-hodgkin lymphoma.
Detailed description
This is an open-label, Phase 1/2a, multi-dose, multi-center trial of orally administered cerdulatinib assessing safety, tolerability, and pharmacokinetic (PK) parameters conducted in 2 phases: * Phase 1: Dose-escalation portion, during which participants will be enrolled to receive a single-agent cerdulatinib at their assigned dose level starting at 15 milligrams (mg) once daily (QD), administered in increasing doses until the maximum tolerated dose (MTD)/maximum administered dose (MAD) is identified. * Phase 2a: Consisting of planned cohorts based on cancer type. The participants will receive single agent cerdulatinib at a starting dose of 35, 30, or 20 mg twice daily (BID) for 28-day cycles except for one of the cohorts, the participants will receive cerdulatinib plus intravenous (IV) rituximab at 375 mg/square meter (m\^2) for 28-day cycles.
Conditions
- Follicular Lymphoma (FL/Indolent NHL)
- Aggressive NHL (a NHL)
- Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)
- T-cell Lymphoma (PTCL and CTCL)
- B-cell Non Hodgkin Lymphoma (NHL)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cerdulatinib | Oral capsule |
| BIOLOGICAL | Rituximab | IV infusion |
Timeline
- Start date
- 2013-08-30
- Primary completion
- 2020-12-15
- Completion
- 2020-12-15
- First posted
- 2013-11-25
- Last updated
- 2022-04-05
- Results posted
- 2022-04-05
Locations
23 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01994382. Inclusion in this directory is not an endorsement.