Combination Chemotherapy Including Cisplatin, Ifosfamide, Gemcitabine, L-asparaginase, Etoposide and Dexamethasone as Treatment of Newly Diagnosed and Relapsed/Refractory Peripheral T Cell Lymphomas
Primary Purpose
Peripheral T Cell Lymphoma
Status
Unknown status
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
cisplatin
ifosfamide
gemcitabine
L-asparaginase
etoposide
dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral T Cell Lymphoma focused on measuring PTCLs
Eligibility Criteria
Inclusion Criteria:
- Patients between the age of 18 - 80 years, with confirmed PTCLs
- Adequate organ functions
- ECOG performance status of <=2
- No history of hypersensitivity to any of the components of the PIGLETS regimen
- Informed consent obtained
Exclusion Criteria:
- Inadequate organ functions
- ECOG performance status of >=3
Sites / Locations
- The University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PIGLETs
Arm Description
Patient will be given this combination of chemotherapy (cisplatin, ifosfamide, gemcitabine, L-asparaginase, etoposide and dexamethasone) for a total of 6 courses
Outcomes
Primary Outcome Measures
Adverse events and severe adverse events
Incidence of AE and SAE by severity grading as assessed according to CTCAE v4.03
Incidence of AE and SAE by severity grading as assessed according to CTCAE v4.03
Overall response rate (ORR)
proportion of patients achieving CR or CRi or partial remission (PR)
Overall response rate (ORR)
proportion of patients achieving CR or CRi or partial remission (PR)
Secondary Outcome Measures
Full Information
NCT ID
NCT03071822
First Posted
February 24, 2017
Last Updated
June 8, 2018
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03071822
Brief Title
Combination Chemotherapy Including Cisplatin, Ifosfamide, Gemcitabine, L-asparaginase, Etoposide and Dexamethasone as Treatment of Newly Diagnosed and Relapsed/Refractory Peripheral T Cell Lymphomas
Official Title
Combination Chemotherapy Including Cisplatin, Ifosfamide, Gemcitabine, L-asparaginase, Etoposide and Dexamethasone (PIGLETS Regimen) as Treatment of Newly Diagnosed and Relapsed/Refractory Peripheral T Cell Lymphomas (PTCLs)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 24, 2017 (Actual)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
February 28, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The PIGLETS regimen was devised to replace the conventional SMILE regimen in management of extranodal NK/T cell lymphoma in our institution. It had been three years since the introduction of PIGLETS regimen in treatment of NK malignancies. The response rate is encouraging, with an overall response rate (ORR) of 90% in NK malignancies. Side effects are generally tolerable. The investigator therefore propose the use of PIGLETS on newly diagnosed or relapsed/refractory PTCLs.
Detailed Description
Peripheral T cell lymphomas (PTCLs) are a group of heterogenous lymphoid malignancies derived from post-thymic mature T-lymphocytes. They are further classified according to their putative origin, immunophenotype, sites of involvement and clinical behaviour. Common subtypes include PTCL-not otherwise specified (PTCL-NOS), angioimmunoblastic T cell lymphoma (AITL) and anaplastic large cell lymphoma (ALCL). With the exception of ALCL, PTCLs behave aggressively and their response to chemotherapy is typically poor. CHOP regimen (cyclophosphamide, doxorubicin, vincristine, prednisolone) borrowed from treatment of B-cell lymphoma is commonly used. However, there is no randomized controlled trial evaluating its efficacy. Moreover, despite the initial response of 40-70%, most patients suffer from disease relapse, giving rise to disappointing five year disease free survival (DFS) and overall survival (OS), typically in the range of 30% and 20%, respectively. As a result, there is not yet a standard agreed-on regimen for treatment of PTCLs in an upfront setting.
One of the possible mechanisms behind the intrinsic resistance to chemotherapy in PTCLs is the overexpression of multi-drug resistance (MDR) gene/P-glycoprotein (P-gp), which mediates active efflux of chemotherapeutic medications out of intracellular compartment. Regimens combining drugs which are independent of the P-gp pathway were proven to be successful in the management of PTCL, extranodal NK/T cell lymphoma, a lymphoma also expressing high level of MDR gene/P-glycoprotein. The PIGLETS regimen was devised to replace the conventional SMILE regimen in management of extranodal NK/T cell lymphoma in our institution. It had been three years since the introduction of PIGLETS regimen in treatment of NK malignancies. The response rate is encouraging, with an overall response rate (ORR) of 90% in NK malignancies. Side effects are generally tolerable. The investigator therefore propose the use of PIGLETS on newly diagnosed or relapsed/refractory PTCLs.
Expected toxicity:
The PIGLETS regimen had been in used since 2013, with the toxicities well known to the investigators
Typical side effects of chemotherapy would be anticipated, including cytopenia, alopecia, mucositis and emesis. These can all be managed with supportive therapy
Anaphylactic reaction to L-asparaginase may occur, but a small test dose will be given before formal administration to ensure the absence of allergy. Prophylactic antihistamine and glucocorticoids will also be given.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T Cell Lymphoma
Keywords
PTCLs
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Patient will be given this combination of chemotherapy (cisplatin, ifosfamide, gemcitabine, L-asparaginase, etoposide and dexamethasone) for a total of 6 courses.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PIGLETs
Arm Type
Experimental
Arm Description
Patient will be given this combination of chemotherapy (cisplatin, ifosfamide, gemcitabine, L-asparaginase, etoposide and dexamethasone) for a total of 6 courses
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
PIGLETs
Intervention Type
Drug
Intervention Name(s)
ifosfamide
Intervention Description
PIGLETs
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Intervention Description
PIGLETs
Intervention Type
Drug
Intervention Name(s)
L-asparaginase
Intervention Description
PIGLETs
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Description
PIGLETs
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Description
PIGLETs
Primary Outcome Measure Information:
Title
Adverse events and severe adverse events
Description
Incidence of AE and SAE by severity grading as assessed according to CTCAE v4.03
Incidence of AE and SAE by severity grading as assessed according to CTCAE v4.03
Time Frame
1 year
Title
Overall response rate (ORR)
Description
proportion of patients achieving CR or CRi or partial remission (PR)
Time Frame
3 months
Title
Overall response rate (ORR)
Description
proportion of patients achieving CR or CRi or partial remission (PR)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients between the age of 18 - 80 years, with confirmed PTCLs
Adequate organ functions
ECOG performance status of <=2
No history of hypersensitivity to any of the components of the PIGLETS regimen
Informed consent obtained
Exclusion Criteria:
Inadequate organ functions
ECOG performance status of >=3
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sau Yan Thomas Chan, MBBS
Phone
852-22554361
Email
thomas28@netvigator.com
First Name & Middle Initial & Last Name or Official Title & Degree
Crosby Lu, BN
Phone
852-22555161
Email
khlu@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yok Lam Kwong, MBBS
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
King Hei Lu, MMedSc
Phone
852-22554361
Ext
1654
Email
khlu@hku.hk
First Name & Middle Initial & Last Name & Degree
Zoe Chan, BNs
Phone
852-22551654
Email
zoechan1@hku.hk
First Name & Middle Initial & Last Name & Degree
Yok Lam Kwong, MD(HK)
First Name & Middle Initial & Last Name & Degree
Thomas Chan, MBBS(HK)
12. IPD Sharing Statement
Learn more about this trial
Combination Chemotherapy Including Cisplatin, Ifosfamide, Gemcitabine, L-asparaginase, Etoposide and Dexamethasone as Treatment of Newly Diagnosed and Relapsed/Refractory Peripheral T Cell Lymphomas
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