Condition or disease | Intervention/treatment | Phase |
---|---|---|
Peripheral T-Cell Lymphoma (PTCL NOS) Nodal Lymphomas of T Follicular Helper (TFH) Follicular T-cell Lymphoma (FTCL) AITL ALCL HSTCL EATL I,II MEITL, EATL Type II Nasal Lymphoma | Drug: Cerdulatinib | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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) |
Estimated Study Start Date : | November 15, 2019 |
Estimated Primary Completion Date : | December 31, 2022 |
Estimated Study Completion Date : | June 1, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Cohort A
Cerdulatinib 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)
|
Drug: Cerdulatinib
Small molecule SYK/JAK kinase inhibitor in development for treatment of hematological malignancies
|
Experimental: Cohort B
Cerdulatinb 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)
|
Drug: Cerdulatinib
Small molecule SYK/JAK kinase inhibitor in development for treatment of hematological malignancies
|
Experimental: Cohort C
Cerdulatinb 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)
|
Drug: Cerdulatinib
Small molecule SYK/JAK kinase inhibitor in development for treatment of hematological malignancies
|
Experimental: Cohort D
Other 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)
|
Drug: Cerdulatinib
Small molecule SYK/JAK kinase inhibitor in development for treatment of hematological malignancies
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Relapsed/refractory disease after prior therapy:
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.
Exclusion Criteria:
Clinically significant cardiac disease, defined by any of the following:
No Contacts or Locations Provided
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | July 8, 2019 | ||||
First Posted Date ICMJE | July 16, 2019 | ||||
Last Update Posted Date | March 12, 2020 | ||||
Estimated Study Start Date ICMJE | November 15, 2019 | ||||
Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Overall Response Rate (ORR) [ Time Frame: Up to 36 months ] ORR is defined as the percentage (%) of participants with a complete response (CR), or partial response (PR) as assessed by IRC per RECIL criteria.
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | CELTIC-1: A Phase 2B Study of Cerdulatinib in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) | ||||
Official Title ICMJE | 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) | ||||
Brief 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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 Phase 3 |
||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||
Condition ICMJE |
|
||||
Intervention ICMJE | Drug: Cerdulatinib
Small molecule SYK/JAK kinase inhibitor in development for treatment of hematological malignancies
|
||||
Study Arms ICMJE |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Withdrawn | ||||
Actual Enrollment ICMJE |
0 | ||||
Original Estimated Enrollment ICMJE |
200 | ||||
Estimated Study Completion Date ICMJE | June 1, 2023 | ||||
Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04021082 | ||||
Other Study ID Numbers ICMJE | 18-604 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE |
|
||||
Responsible Party | Portola Pharmaceuticals | ||||
Study Sponsor ICMJE | Portola Pharmaceuticals | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Portola Pharmaceuticals | ||||
Verification Date | March 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |