Phase 2
Completed N=263
Phase 1/2a Dose Escalation Study in Participants With CLL, SLL, or NHL
Source: ClinicalTrials.gov NCT01994382 ↗Enrolled (actual)
263
Serious AEs
49.4%
Results posted
Apr 2022
Primary outcomePrimary: Phase 1: Number of Participants With a Dose Limiting Toxicity (DLT) — 0; 0; 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1: Number of Participants With a Dose Limiting Toxicity (DLT) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Phase 2a: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator |
12; 6; 15; 5; 14; 0 | — |
| SECONDARY Phase 1: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator |
0; 1; 1; 0; 0; 0 | — |
| SECONDARY Phase 1: Number of Participants Achieving Clinical Benefit |
2; 4; 4; 1; 1; 0 | — |
| SECONDARY Phase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE) |
3; 6; 7; 3; 3; 3 | — |
| SECONDARY Phase 1: Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC0-12) of Cerdulatinib |
709.6; 1040; 1826; 601.4; 2064; 674.5 | — |
| SECONDARY Phase 2a: Median Time to Progression-Free Survival (PFS) |
12.68; 3.61; 18.33; NA; 4.57; 1.18 | — |
| SECONDARY Phase 2a: Number of Participants Achieving Clinical Benefit |
19; 8; 16; 10; 17; 2 | — |
| SECONDARY Phase 2a: Number of Participants Achieving Dominant Mass Response (DMR) |
14; 5; 14; 7; 15; 1 | — |
Eligibility Criteria
Inclusion Criteria
Phase 1 Inclusion
- Participant at least 18 years of age with histologically confirmed CLL/SLL or B-cell non-Hodgkin lymphoma (diffuse large B-cell lymphoma [DLBCL], FL, mantle cell lymphoma [MCL], marginal zone lymphoma [MZL], lymphoplasmacytic lymphoma).
Phase 2a Inclusion
- Histological evidence: FL Grade 1-3A, with relapsed or refractory disease; aggressive NHL (aNHL), defined as DLBCL, FL Grade 3B, MCL, and transformed NHL with relapsed disease; CLL/SLL, peripheral T-cell lymphoma (PTCL), or cutaneous T-cell lymphoma (CTCL) (with mycosis fungoides [MF]/Sézary Syndrome [SS]) with relapsed or refractory disease
- Received B-cell receptor (BCR) and/or BCL2 inhibitors and were intolerant or had relapsed/refractory disease afterwards
- Prior treatment for lymphoid malignancy for progressive /refractory disease
- ≥1 prior regimen (minimum 2 cycles) with antibody conjugate/cytotoxic chemotherapy.
- Measurable disease defined as: ≥1 lesion that measures ≥1.5 centimeter (cm) single dimension via computed tomography (CT), CT/positive-emission tomography (PET) with nodal or mass lesions; quantifiable circulating tumor cells; and for CTCL: Modified Severity Weighted Assessment Tool (mSWAT) >0
- Ability to provide diagnostic reports
General Inclusion
- Eastern Cooperative Oncology Group (ECOG) Score of 0 or 1
- Hematologic absolute neutrophil count (ANC) >1000/microliter (uL) and platelet >75,000/uL
- Creatinine levels as specified by Investigator
- Bilirubin 20 mg QD prednisone (or equivalent)
- Breastfeeding or pregnant (intention to become) females or participation in other clinical trials
Data sourced from ClinicalTrials.gov (NCT01994382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.