CELTIC-1: A Phase 2B Study of Cerdulatinib in Patients With Relapsed/Refractory Peripheral T-Cell… (NCT04021082) | Clinical Trial Compass
WithdrawnPhase 2/3
CELTIC-1: A Phase 2B Study of Cerdulatinib in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)
Stopped: Sponsor decision to not initiate the trial
0Started 2019-11-15
Plain-language summary
This is an open-label, multinational study of cerdulatinib in patients with relapsed/refractory PTCL dosed with cerdulatinb, designed to (1) Evaluate tumor response, (2) Assess the safety and tolerability of cerdulatinib, (3) Evaluate duration of response (DUR), progression free survival (PFS) and overall survival(OS), (4) Determine the PK properties of cerdulatinib, (5) Evaluate the efficacy endpoints based on Lugano criteria per IRC and (6)To assess the relationship between target expression (e.g., spleen tyrosine kinase \[SYK\], Janus kinase \[JAK\]) and relevant anomalies (e.g., SYK-ITK translocation, mutations in the JAK/STAT pathway) with clinical response.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Ability to give informed consent.
✓. A histologically confirmed diagnosis, per the WHO 2016 classification \[45\], of any PTCL subtype listed for study. Patients may be entered on the basis of local pathology. Local pathology slides must be available for central pathology review.
✓. Prior therapy consisting of at least one systemic regimen that involved at least two cycles of treatment.
✓. In patients with ALCL, prior treatment with brentuximab vendotin unless, in the judgment of the Investigator, such treatment was otherwise contraindicated.
✓. Relapsed/refractory disease after prior therapy:
✓. Age ≥ 18 years.
✓. A life expectancy of \> 3 months.
✓. An Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
✕. Allogeneic or autologous stem cell transplantation within 90 days of study drug initiation or active immunosuppressive therapy for graft-versus-host disease (GVHD) or GVHD prophylaxis within 8 weeks of study drug initiation.
✕. Prior cancer therapy with an SYK or JAK inhibitor.
✕. The need for chronic treatment with a strong inhibitor, sensitive substrate, or inducer of CYP3A4.
✕. Known active lymphoma involvement of the central nervous system.
✕. Persistent unresolved toxicity associated with prior treatment that is of Grade ≥ 2 severity (per v5.0 of the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\]) and is also clinically significant in the judgement of the Investigator. Exceptions are alopecia, erectile impotence, hot flashes, diminished libido, and neuropathy.
✕. Other treatment for the PTCL subtype within 3 weeks of study drug initiation.
✕. Known infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) or known HBV or HCV carrier status.