Status:
COMPLETED
Romidepsin, Gemcitabine, Dexamethasone and Cisplatin in the Treatment of Peripheral T-Cell and Diffuse Large B-Cell Lymphoma
Lead Sponsor:
Canadian Cancer Trials Group
Collaborating Sponsors:
Celgene
Conditions:
Peripheral T-Cell Lymphoma
Diffuse Large B-Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This research is being done because it is not yet known what dose of romidepsin in combination with gemcitabine, dexamethasone, and cisplatin (GDP) can be given safely to patients with peripheral T-ce...
Detailed Description
The purpose of this study is to find the highest dose of romidepsin that can safely be given in combination with gemcitabine, dexamethasone, and cisplatin (GDP) without causing very severe side effect...
Eligibility Criteria
Inclusion
- Patients with histologically confirmed PTCL. Biopsy proof of disease at initial diagnosis is mandatory. A biopsy at relapse is preferred but not mandatory.
- Patients must have received one or two previous regimens of therapy for their disease (salvage chemotherapy plus autologous stem cell transplantation is considered to be one regimen).
- Clinically and / or radiologically measurable disease (1 site bidimensionally measurable). Measurements / evaluations must be done within 28 days prior to registration.
- Age 18 to 75 years.
- ECOG performance status 0, 1 or 2.
- Life expectancy of ≥ 90 days (3 months).
- Laboratory Requirements: (must be done within 7 days of registration)
- Hematology:
- Granulocytes (AGC) ≥ 1.0 x 10\^9/L
- Platelets ≥ 75 x 10\^9/L (≥ 50 if bone marrow involvement by lymphoma)
- Biochemistry:
- AST and ALT ≤ 2.5x ULN (≤ 5x ULN if hepatic involvement of disease)
- Serum total bilirubin ≤ 1.5x ULN (≤ 3x ULN if hepatic involvement of disease, or ≤5x ULN if Gilberts Disease)
- Serum Potassium ≥ 3.8 mmol/L\*
- Serum Magnesium ≥ 0.85 mmol/L\* \* NB: Patients with potassium and magnesium levels below these values are eligible if supplementation has corrected these deficits. This supplementation should continue throughout the course of the study.
- Calculated creatinine clearance (Cockcroft-Gault formula) of ≥ 50 mL /min.
- Women must be post-menopausal, surgically sterile or use reliable forms of contraception while on study and for 90 days after discontinuing therapy. Women of childbearing potential must have a pregnancy test taken and proven negative within 7 days prior to registration and must not be lactating.
- Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements.
- Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial.
- In accordance with NCIC CTG policy, protocol treatment is to begin within 2 working days of patient registration.
Exclusion
- Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer and superficial bladder cancer, curatively treated in-situ cancer of the cervix or breast or localized excised prostate cancer, or other solid tumours curatively treated with no evidence of disease for ≥ 3 years.
- Central nervous system involvement, meningeal or parenchymal. Patients with CNS disease at initial presentation and who are in a CNS CR at the time of relapse are eligible. MRI scanning and / or lumbar puncture should be performed if there is clinical suspicion of active CNS disease.
- HIV, active hepatitis B or current hepatitis C infection. (Hepatitis B core antibody positive, surface antigen negative patients allowed if concurrent anti-viral prophylaxis is administered. Patients with a past history of hepatitis C who have eradicated the virus are eligible.)
- Any serious active disease or co-morbid medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating (according to investigator's decision).
- Patients with serious cardiac illness or condition including, but not limited to:
- history of documented congestive heart failure (CHF)
- systolic dysfunction (LVEF \< 45% by MUGA or ECHO)
- high risk uncontrolled arrhythmias (ventricular tachycardia, high-grade AV-block, supraventricular arrhythmias which are not adequately rate-controlled)
- unstable angina pectoris requiring anti-anginal medication
- clinically significant valvular heart disease
- evidence of transmural infarction on ECG
- New York Heart Association (NYHA) Class III or IV functional status
- patients with congenital long QT syndrome, history of significant cardiovascular disease and/or taking drugs leading to significant QT prolongation
- patients with QTc \> 480 msec are not eligible
- Pregnant or lactating females or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study.
- Patients with active or uncontrolled infections, or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol are not eligible.
- Patients are not eligible if they have a known hypersensitivity to the study drugs or their components.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2018
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01846390
Start Date
October 1 2013
End Date
September 19 2018
Last Update
August 4 2023
Active Locations (6)
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1
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
2
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
3
Regional Health Authority B, Zone 2
Saint John, New Brunswick, Canada, E2L 4L2
4
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7