Romidepsin, Gemcitabine, Dexamethasone and Cisplatin in the Treatment of Peripheral T-Cell and Diffuse Large B-Cell Lymphoma
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01846390|
Recruitment Status : Completed
First Posted : May 3, 2013
Last Update Posted : November 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Peripheral T-Cell Lymphoma Diffuse Large B-Cell Lymphoma||Drug: Gemcitabine Drug: Dexamethasone Drug: Cisplatin Drug: Romidepsin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Romidepsin, Gemcitabine, Dexamethasone and Cisplatin Combination Therapy in the Treatment of Peripheral T-Cell and Diffuse Large B-Cell Lymphoma|
|Actual Study Start Date :||April 30, 2013|
|Actual Primary Completion Date :||July 6, 2016|
|Actual Study Completion Date :||September 19, 2018|
Experimental: romidepsin, gemcitabine, dexamethasone and cisplatin
A traditional phase I dose escalation design is proposed to assess the feasibility and tolerability of romidepsin in combination with GDP, where treatment will be escalated. Treatment will be given for 6 cycles unless there is evidence of progression prior to completion of the 6 cycles or tolerability to the regimen is not sustained.
Group 1 = 1000 mg/m2 D1, D8. Subsequent dose levels according to toxicity = 600-1000 mg/m2 D1, D15.
40 mg D1 - D4
75 mg/m2 D1
Dose Level 0 - 6 mg/m2 D1, D8. Subsequent dose levels according to toxicity 6-14 mg/m2 D1, D15.
- Maximum tolerated dose of combined romidepsin, gemcitabine, dexamethasone and cisplatin. [ Time Frame: 48 months ]
Combination of GDP with romidepsin at the maximum tolerated doses of these agents will identify the combination regimen for comparison in the subsequent randomized phase II trial; if romidepsin appears to improve the activity of GDP, then this will move forward to a formal phase III comparison to CHOP.
Primary end points are toxicity, the maximum administered dose and the recommended phase II dose.
- Number of patients with adverse events [ Time Frame: 48 months ]Adverse events by grade, dose level and total incidence; vital signs will be summarized and DLTs reported separately
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): NCT01846390
|Tom Baker Cancer Centre|
|Calgary, Alberta, Canada, T2N 4N2|
|Canada, British Columbia|
|BCCA - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Canada, New Brunswick|
|Regional Health Authority B, Zone 2|
|Saint John, New Brunswick, Canada, E2L 4L2|
|Canada, Nova Scotia|
|QEII Health Sciences Centre|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|Odette Cancer Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Univ. Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Study Chair:||Anthony J Reiman||Atlantic Health Sciences Corp - Saint John Regional Hospital, Saint John NB Canada|
|Study Chair:||Kerry J Savage||BCCA Vancouver Cancer Centre, Vancouver BC Canada|