Combination Chemotherapy Including Cisplatin, Ifosfamide, Gemcitabine, L-asparaginase, Etoposide and Dexamethasone as Treatment of Newly Diagnosed and Relapsed/Refractory Peripheral T Cell Lymphomas

NCT03071822 | Unknown Phase 4

• 1 other identifier: PTCL-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral T Cell Lymphoma

Keywords

PTCLs

Outcome Measures

Primary Outcomes (3)

• 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

  1 year

• Overall response rate (ORR)

  proportion of patients achieving CR or CRi or partial remission (PR)

  3 months

• Overall response rate (ORR)

  proportion of patients achieving CR or CRi or partial remission (PR)

  6 months

Study Arms (1)

PIGLETs

EXPERIMENTAL

Patient will be given this combination of chemotherapy (cisplatin, ifosfamide, gemcitabine, L-asparaginase, etoposide and dexamethasone) for a total of 6 courses

Drug: cisplatin; Drug: ifosfamide; Drug: gemcitabine; Drug: L-asparaginase; Drug: etoposide; Drug: dexamethasone

Interventions

cisplatin DRUG

PIGLETs

PIGLETs

ifosfamide DRUG

PIGLETs

PIGLETs

gemcitabine DRUG

PIGLETs

PIGLETs

L-asparaginase DRUG

PIGLETs

PIGLETs

etoposide DRUG

PIGLETs

PIGLETs

dexamethasone DRUG

PIGLETs

PIGLETs

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inadequate organ functions
• ECOG performance status of \>=3

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

Cisplatin; Ifosfamide; Gemcitabine; Asparaginase; Etoposide; Dexamethasone

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Study Officials

• Yok Lam Kwong, MBBS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sau Yan Thomas Chan, MBBS

CONTACT

852-22554361; thomas28@netvigator.com

Crosby Lu, BN

CONTACT

852-22555161; khlu@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Professor

Model Details: Patient will be given this combination of chemotherapy (cisplatin, ifosfamide, gemcitabine, L-asparaginase, etoposide and dexamethasone) for a total of 6 courses.

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: March 7, 2017
• Study Start: February 24, 2017
• Primary Completion: July 31, 2021
• Study Completion: February 28, 2022
• Last Updated: June 11, 2018

Record last verified: 2018-06

Locations

HK (1)