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

First listed

Nov 25, 2013

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)