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Peripheral T-Cell Lymphoma (PTCL NOS)Phase 2/3NCT04021082

CELTIC-1: A Phase 2B Study of Cerdulatinib in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)

A Phase 2/3 study testing Cerdulatinib in people with Peripheral T-Cell Lymphoma (PTCL NOS) and Nodal Lymphomas of T Follicular Helper (TFH), run by Portola Pharmaceuticals.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cerdulatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
15 Nov 2019to 1 Jun 2023
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Refractory is defined as progression during treatment or recurrence/progression of disease within ≤ 6 months of completing a treatment regimen that resulted in either SD, a PR, or a CR.
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  • Relapse is defined as progression or recurrence of disease after a prior documented response (CR or PR) and > 6 months since last treatment.
  • Age ≥ 18 years.
  • A life expectancy of > 3 months.
  • An Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
  • Adequate bone marrow reserve, defined as an ANC ≥ 1,000/µL and a platelet count ≥ 75,000/µL. The ANC must be without growth factor support for 7 days, and the platelet count must be without transfusion support within 7 days of study drug initiation. Patients with evidence of marrow involvement must have a platelet count ≥ 50,000/μL.
  • NOTE: There are no limits on ANC or platelet count for patients with HSTCL as long as cytopenia, if present, is secondary to disease.
  • Adequate renal function, defined as a creatinine clearance of ≥ 30 mL/min calculated using the Cockcroft-Gault equation or based on a 24-hour urine specimen.
  • Adequate hepatic function, defined as: i) a serum bilirubin level ≤ 1.5 × ULN; and ii) serum AST/ALT levels ≤ 2.5 × the ULN for the reference lab. A serum bilirubin level ≤ 2.5 mg/dL is permissible if it is clearly due to Gilbert's syndrome. In patients with lymphoma and documented hepatic involvement, adequate hepatic function is defined as: i) total bilirubin level ≤ 2 × ULN; and ii) AST/ALT levels ≤ 3 × ULN.
  • Measurable disease for a given tumor type, defined as the presence of ≥ 1 lesion measurable per RECIL criteria (≥ 15 mm) as assessed by CT or, in patients with nodal or mass lesions, by CT/PET.
  • Female patients of childbearing potential and male patients must agree to abstain from sexual intercourse or to use an effective method of contraception during the study, for 90 days after the last dose of study drug. Examples of effective methods of contraception include oral contraceptives or double barrier methods such as a condom plus spermicide or a condom plus a diaphragm.

Who cannot join

  • A diagnosis of any one of the following PTCL subtypes: (i) primary cutaneous T-cell lymphoma, including primary cutaneous ALCL and primary cutaneous gamma-delta lymphoma; (ii) mycosis fungoides, including that with large-cell transformation; (iii) Sézary syndrome; and (iv) leukemic forms of PTCL (e.g., adult T cell leukemia/lymphoma, T cell prolymphocytic leukemia, T-cell large granular lymphocyte leukemia, aggressive NK leukemia).
  • 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.
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  • 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.
  • Active infection requiring systemic treatment, defined as the need for intravenous antimicrobial, antifungal, or antiviral agents.
  • Clinically significant cardiac disease, defined by any of the following:
  • A history of clinically significant cardiac disease or congestive heart failure (New York Heart Association Class II). Patients must not have unstable angina (anginal symptoms at rest) or new-onset angina within the last 90 days or myocardial infarction (MI) within the past 6 months.
  • Clinically significant cardiac arrhythmias, defined as requiring anti-arrhythmic therapy (excluding beta blockers or digoxin). Patients with controlled atrial fibrillation are not excluded.
  • Congenital long QT syndrome or concomitant medications known to prolong the QT interval except those required for infections that carry a low risk of QTc prolongation.
  • A Fridericia-corrected QT interval of ≥ 450 msec (males) or ≥ 470 msec (females) at screening.
  • Difficulty swallowing or malabsorption syndrome.
  • Known history of acute pancreatitis within the last 30 days or a known history of chronic pancreatitis.
  • Major surgery within 28 days of study drug initiation.
  • A history of another malignancy within the 2-year period prior to study drug initiation unless the malignancy was treated with curative intent and the likelihood of its relapse is small (< 5% in 2 years in the judgement of the Investigator). Patients with a history of basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix may be enrolled. Patients receiving adjuvant hormonal therapy for breast or prostate cancer are eligible as long as there is no detectable disease at study entry.
  • Chronic systemic steroid treatment at doses greater than the equivalent of prednisone at 20 mg/day, with the exception of intermittent use for the treatment of emesis.
  • Women who are breast-feeding, pregnant, or intend to become pregnant while on study.
  • Known hypersensitivity to any of the components of cerdulatinib.
  • Participation in any other therapeutic clinical study (observational or registry trials are allowed, as is long-term follow-up from other studies for survival).
  • Presence of any other medical, psychological, familial, sociological, or geographic condition potentially hampering compliance with the protocol or that, in the judgment of the Investigator, would interfere with the study endpoints or the patient's ability to participate in the study.

About this study

Official title: CELTIC-1 (Clinical Evaluation of T-cell NHL With Cerdulatinib): A Phase 2b, Open Label, Multidose, Multinational Study of Cerdulatinib (PRT062070) in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL)

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.

Being tested
Cerdulatinib
Keywords
Non-Hodgkin's Lymphoma, T-Cell Leukemia, Peripheral T-Cell Lymphoma, Nodal, PTCL, Angioimmunoblastic, AITL, Anaplastic, ALCL, EATL, Follicular, FTCL, hepatosplenic, HSTCL, TFL, SYK, JAK/STAT
Medical subject headings
Lymphoma, T-Cell, Peripheral, Lymphoma, Non-Hodgkin, Leukemia, T-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CerdulatinibDrug

    Small molecule SYK/JAK kinase inhibitor in development for treatment of hematological malignancies

Study groups in NCT04021082
Study groupRoleWhat they receive
Cohort AExperimentalCerdulatinib dosing of patients with Peripherial T-Cell Lymphoma (PTCL) not otherwise specified (NOS); Cerdulatinib 30 mg orally (PO) twice daily (BID) (60 mg daily total)
Receives: Drug: Cerdulatinib
Cohort BExperimentalCerdulatinb dosing of patients with nodal lymphomas of T follicular helper (TFH) phenotype origin, including angioimmunoblastic T cell lymphoma (AITL), follicular T-cell lymphoma (FTCL), and nodal PTCL with TFH phenotype; Cerdulatinib 30 mg orally (PO) twice daily (BID) (60 mg daily total)
Receives: Drug: Cerdulatinib
Cohort CExperimentalCerdulatinb dosing of patients with Anaplastic large cell lymphoma (ALCL) (anaplastic lymphoma kinase positive [ALK+] and negative [ALK-]); Cerdulatinib 30 mg orally (PO) twice daily (BID) (60 mg daily total)
Receives: Drug: Cerdulatinib
Cohort DExperimentalOther rare types of extranodal non-cutaneous aggressive PTCL, including hepatosplenic T-cell lymphoma (HSTCL), enteropathy-associated T-cell lymphoma (EATL type I), monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL, EATL type II), and extranodal NK/T-cell lymphoma (nasal type); Cerdulatinib 30 mg orally (PO) twice daily (BID) (60 mg daily total)
Receives: Drug: Cerdulatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR)

    ORR is defined as the percentage (%) of participants with a complete response (CR), or partial response (PR) as assessed by IRC per RECIL criteria.

    Measured: Up to 36 months

Secondary outcomes (4)

  1. Complete response (CR)

    Rate is defined as the percentage of patients who have a best response of CR. CR rate will be analyzed by cohort.

    Measured: Up to 36 months

  2. Duration of response (DOR)

    DOR is defined as the time from date of first observed response (CR or PR) to date of PD or death, whichever occurs first. Patients who do not progress or die will be censored on the date of last evaluable tumor assessment. DOR will be analyzed by cohort.

    Measured: Up to 36 months

  3. Progression-free survival (PFS)

    PFS is defined as the time from start date of study drug therapy to date of disease progression or death, whichever occurs first. Patients who do not progress or die will be censored on the date of last evaluable tumor assessment. PFS will be analyzed by cohort.

    Measured: Up to 36 months

  4. Overall survival (OS)

    OS is defined as the time from start date of study drug therapy to date of death. Patients who do not die will be censored on the date of last contact. OS will be analyzed by cohort.

    Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2019
  2. Study start15 Nov 2019 (estimated)
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion1 Jun 2023 (estimated)

Why it stopped: Sponsor decision to not initiate the trial

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04021082
Sponsor's protocol ID
18-604
Status last verified
Mar 2020
First submitted
8 Jul 2019
Last updated
21 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Cerdulatinib in people with Peripheral T-Cell Lymphoma (PTCL NOS) and Nodal Lymphomas of T Follicular Helper (TFH), run by Portola Pharmaceuticals.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04021082.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.

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