Phase 1/2a Dose Escalation Study in Participants With CLL, SLL, or NHL

Conditions

• Aggressive NHL (a NHL)
• B-cell Non Hodgkin Lymphoma (NHL)
• Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)
• Follicular Lymphoma (FL/Indolent NHL)
• T-cell Lymphoma (PTCL and CTCL)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cerdulatinib — DRUG
  Oral capsule
• Rituximab — BIOLOGICAL
  IV infusion

Study Details

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.

Key Dates

Start date

Aug 30, 2013

Status verified

Apr 2022

Primary completion

Dec 15, 2020

Completion

Dec 15, 2020

Study Design

Enrollment

260 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Phase 1 Cerdulatinib
  During Phase 1, participants will receive oral cerdulatinib on Day 1 and then starting on Day 4 at doses of 15 mg up to 100 mg QD or oral cerdulatinib at doses of 15 mg up to 45 mg BID in 28-day cycles (except Cohort 1 will have a 21-day cycle starting on Day 1) for up to 10 cycles.
• Experimental: Phase 2a Cerdulatinib
  During Phase 2a, participants in cohorts based on cancer type will receive oral cerdulatinib at starting doses of 35, 30, or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib can be reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
• Experimental: Phase 2a Cerdulatinib plus Rituximab
  During Phase 2a, participants in this cohort will receive oral cerdulatinib at their applicable dose and an IV injection of rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10.

Primary Outcome Measure

Phase 1: Number of Participants With a Dose Limiting Toxicity (DLT) [ Time Frame: Baseline up to Day 28 of Cycle 1 (cycle = 21 days or 28 days) ]

Locations (23)