Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 64 of 430 for:    ifosfamide

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03071822
Recruitment Status : Recruiting
First Posted : March 7, 2017
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
Professor Yok-lam Kwong, The University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Peripheral T Cell Lymphoma Drug: cisplatin Drug: ifosfamide Drug: gemcitabine Drug: L-asparaginase Drug: etoposide Drug: dexamethasone Phase 4

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:

  1. The PIGLETS regimen had been in used since 2013, with the toxicities well known to the investigators
  2. Typical side effects of chemotherapy would be anticipated, including cytopenia, alopecia, mucositis and emesis. These can all be managed with supportive therapy
  3. 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
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)
Actual Study Start Date : February 24, 2017
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : February 28, 2022


Arm Intervention/treatment
Experimental: PIGLETs
Patient will be given this combination of chemotherapy (cisplatin, ifosfamide, gemcitabine, L-asparaginase, etoposide and dexamethasone) for a total of 6 courses
Drug: cisplatin
PIGLETs

Drug: ifosfamide
PIGLETs

Drug: gemcitabine
PIGLETs

Drug: L-asparaginase
PIGLETs

Drug: etoposide
PIGLETs

Drug: dexamethasone
PIGLETs




Primary Outcome Measures :
  1. Adverse events and severe adverse events [ Time Frame: 1 year ]

    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


  2. Overall response rate (ORR) [ Time Frame: 3 months ]
    proportion of patients achieving CR or CRi or partial remission (PR)

  3. Overall response rate (ORR) [ Time Frame: 6 months ]
    proportion of patients achieving CR or CRi or partial remission (PR)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients between the age of 18 - 80 years, with confirmed PTCLs
  2. Adequate organ functions
  3. ECOG performance status of <=2
  4. No history of hypersensitivity to any of the components of the PIGLETS regimen
  5. Informed consent obtained

Exclusion Criteria:

  1. Inadequate organ functions
  2. ECOG performance status of >=3

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071822


Contacts
Layout table for location contacts
Contact: Sau Yan Thomas Chan, MBBS 852-22554361 thomas28@netvigator.com
Contact: Crosby Lu, BN 852-22555161 khlu@hku.hk

Locations
Layout table for location information
Hong Kong
The University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: King Hei Lu, MMedSc    852-22554361 ext 1654    khlu@hku.hk   
Contact: Zoe Chan, BNs    852-22551654    zoechan1@hku.hk   
Principal Investigator: Yok Lam Kwong, MD(HK)         
Sub-Investigator: Thomas Chan, MBBS(HK)         
Sponsors and Collaborators
The University of Hong Kong
Investigators
Layout table for investigator information
Principal Investigator: Yok Lam Kwong, MBBS The University of Hong Kong

Layout table for additonal information
Responsible Party: Professor Yok-lam Kwong, Chair Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03071822     History of Changes
Other Study ID Numbers: PTCL-001
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018

Layout table for additional information
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

Keywords provided by Professor Yok-lam Kwong, The University of Hong Kong:
PTCLs

Additional relevant MeSH terms:
Layout table for MeSH terms
Ifosfamide
Isophosphamide mustard
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cisplatin
Dexamethasone
Gemcitabine
Etoposide
Etoposide phosphate
Asparaginase
Dexamethasone acetate
BB 1101
Antineoplastic Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists