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Bortezomib With Combination of Gemcitabine, Ifosfamide and Oxaliplatin in Untreated NK/T Cell Lymphoma (Gifox-B)

Primary Purpose

Extranodal NK-T-CELL LYMPHOMA

Status

Terminated

Phase

Phase 2

Locations

Singapore

Study Type

Interventional

Intervention

GIFOX-Bortezomib

IMRT

About this trial

This is an interventional treatment trial for Extranodal NK-T-CELL LYMPHOMA

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Extranodal NK/T-cell lymphomas
Confirmed pathological diagnosis by the Department of Pathology SGH/NUH/TTSH.
Age more than or equals to 21 years.
Stages IB or bulky disease, II - IV
ECOG performance 0-2
Laboratory tests: ANC more than or equals to 1000/mm3, platelet more than or equals to 75,000/mm3. Creatinine less than or equals to 2x ULN or creatinine clearance more than or equals to 50 ml/min; AST and ALT less than or equals to 3x ULN. Total bilirubin < 1.5x ULN except < 3x ULN in patients with Gilbert's (as defined as > 80% unconjugated hyperbilirubinemia without other known cause); unless impairment is due to organ involvement by lymphoma.
Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria

Had prior systemic chemotherapy. Patients may be entered if they have had prior limited-field radiotherapy or a short course of glucocorticoids or single agent chemotherapy for an urgent local problem at diagnosis (e.g. epidural cord compression, superior vena caval syndrome).
History of peripheral neuropathy
HIV positive
Presence of CNS disease
Hypersensitivity to bortezomib, boron, or mannitol
Contraindication to any cytotoxic drug contained in the chemotherapy regimen.
Female subject of child-bearing potential not willing to use an acceptable method of birth control (i.e. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and one year beyond treatment completion.
Female subject pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotrophin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for women without child-bearing potential.
Invasive or active malignancy in past 2 years.
Serious concomitant medical illnesses that would jeopardize the patient's ability to receive the regimen with reasonable safety.

Sites / Locations

National Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Early stage (IB or bulky disease - II)

Advanced stage (III - IV)

Arm Description

who will receive GIFOX-B chemotherapy followed by involved field radiotherapy.

will receive only chemotherapy alone

Outcomes

Primary Outcome Measures

Response rates of bortezomib in combination with GIFOX (GIFOX-B) chemotherapy with or without intensity-modulated radiation therapy (IMRT)

Assess the response rates of bortezomib in combination with GIFOX (GIFOX-B) chemotherapy together with intensity-modulated radiation therapy (IMRT) in stage IB or bulky disease - II patients and chemotherapy alone in stage III - IV patients.

Secondary Outcome Measures

Progression free survival (PFS) of the combination of GIFOX-B chemotherapy with IMRT in stage IB and III - IV patients

Overall survival (OS) of the combination of GIFOX-B chemotherapy with IMRT in stage IB and III - IV patients

Toxicity of bortezomib administered in combination with GIFOX chemotherapy

Access the toxicity of treatment according to CTC AE 4.0

Full Information

NCT ID

NCT02808091

First Posted

June 9, 2016

Last Updated

September 2, 2016

Sponsor

National Cancer Centre, Singapore

1. Study Identification

Unique Protocol Identification Number

NCT02808091

Brief Title

Bortezomib With Combination of Gemcitabine, Ifosfamide and Oxaliplatin in Untreated NK/T Cell Lymphoma

Acronym

Gifox-B

Official Title

Phase II Trial of Bortezomib With Combination of Gemcitabine, Ifosfamide and Oxaliplatin (GIFOX-B)in Untreated NK/T Cell Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Terminated

Why Stopped

Slow recruitment

Study Start Date

March 2011 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cancer Centre, Singapore

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Assess responses, progression free survival (PFS) and overall survival (OS) of the combination of GIFOX-B chemotherapy with intensity-modulated radiation therapy (IMRT) in Stage IB or bulky disease - II and without IMRT in Stage III - IV. Assess the toxicity and maximum tolerated dose of bortezomib administered in combination with GIFOX chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Extranodal NK-T-CELL LYMPHOMA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Early stage (IB or bulky disease - II)

Arm Type

Experimental

Arm Description

who will receive GIFOX-B chemotherapy followed by involved field radiotherapy.

Arm Title

Advanced stage (III - IV)

Arm Type

Experimental

Arm Description

will receive only chemotherapy alone

Intervention Type

Drug

Intervention Name(s)

GIFOX-Bortezomib

Intervention Description

GIFOX-Bortezomib will be given every 21 days for 4 cycles

Intervention Type

Drug

Intervention Name(s)

GIFOX-Bortezomib

Intervention Description

GIFOX-Bortezomib will be given every 21 days for a total of 6 cycles.

Intervention Type

Radiation

Intervention Name(s)

IMRT

Other Intervention Name(s)

Intensity-modulated radiation therapy

Intervention Description

a minimum of 50 Gy of IMRT to tumor bed and neck (5 weeks)

Primary Outcome Measure Information:

Title

Response rates of bortezomib in combination with GIFOX (GIFOX-B) chemotherapy with or without intensity-modulated radiation therapy (IMRT)

Description

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Progression free survival (PFS) of the combination of GIFOX-B chemotherapy with IMRT in stage IB and III - IV patients

Time Frame

3 years

Title

Overall survival (OS) of the combination of GIFOX-B chemotherapy with IMRT in stage IB and III - IV patients

Time Frame

5 years

Title

Toxicity of bortezomib administered in combination with GIFOX chemotherapy

Description

Access the toxicity of treatment according to CTC AE 4.0

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Extranodal NK/T-cell lymphomas Confirmed pathological diagnosis by the Department of Pathology SGH/NUH/TTSH. Age more than or equals to 21 years. Stages IB or bulky disease, II - IV ECOG performance 0-2 Laboratory tests: ANC more than or equals to 1000/mm3, platelet more than or equals to 75,000/mm3. Creatinine less than or equals to 2x ULN or creatinine clearance more than or equals to 50 ml/min; AST and ALT less than or equals to 3x ULN. Total bilirubin < 1.5x ULN except < 3x ULN in patients with Gilbert's (as defined as > 80% unconjugated hyperbilirubinemia without other known cause); unless impairment is due to organ involvement by lymphoma. Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria Had prior systemic chemotherapy. Patients may be entered if they have had prior limited-field radiotherapy or a short course of glucocorticoids or single agent chemotherapy for an urgent local problem at diagnosis (e.g. epidural cord compression, superior vena caval syndrome). History of peripheral neuropathy HIV positive Presence of CNS disease Hypersensitivity to bortezomib, boron, or mannitol Contraindication to any cytotoxic drug contained in the chemotherapy regimen. Female subject of child-bearing potential not willing to use an acceptable method of birth control (i.e. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and one year beyond treatment completion. Female subject pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotrophin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for women without child-bearing potential. Invasive or active malignancy in past 2 years. Serious concomitant medical illnesses that would jeopardize the patient's ability to receive the regimen with reasonable safety.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Soon Thye LIM

Organizational Affiliation

National Cancer Centre, Singapore

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Centre

City

Singapore

ZIP/Postal Code

169610

Country

Singapore

12. IPD Sharing Statement

Learn more about this trial

Bortezomib With Combination of Gemcitabine, Ifosfamide and Oxaliplatin in Untreated NK/T Cell Lymphoma

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