Experimental cocktail targets Hard-to-Treat lymphomas
NCT ID NCT01846390
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested a combination of four drugs—romidepsin, gemcitabine, dexamethasone, and cisplatin—in 21 people with peripheral T-cell or diffuse large B-cell lymphoma who had already tried other treatments. The main goal was to find a safe dose of romidepsin when added to the standard GDP chemotherapy. Researchers also looked at side effects and whether the combo might work better than existing options.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- romidepsin, gemcitabine, dexamethasone, cisplatin
- What this could lead to
- If successful, this could lead to a more effective chemotherapy combination for certain lymphomas, potentially improving survival.
- What could go wrong
- This is a very early Phase I trial with only 21 participants, focused on safety and dosing. It is too small to prove effectiveness, and side effects may be significant.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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21 people
The number who actually took part.
- Started
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Oct 2013
- Finished
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Sep 2018
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
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Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
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QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7, Canada
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Regional Health Authority B, Zone 2
Saint John, New Brunswick, E2L 4L2, Canada
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Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
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Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
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