Sponsor study identifier
interventional
49
1 country
21
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2016
Actual (reported)Study Completion
April 26, 2017
Actual (reported)Phase I portion: To confirm safety and tolerability in recurrent/refractory peripheral T-cell lymphoma patients during repeated oral administration of forodesine 300 mg twice daily (600 mg/day) for 28 days, and determine the recommended dose. Also, to evaluate pharmacokinetics. Phase II portion: To evaluate the efficacy, safety, and pharmacokinetics of the recommended dosage regimen determined in the phase I portion. The primary efficacy endpoint shall be objective response rate (ORR).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 26, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
January 22, 2013
Actual (reported)January 28, 2013
Actual (reported)March 2016
Actual (reported)April 26, 2017
Actual (reported)Objective response rate (ORR) based on evaluation by image assessment committee
2 years
Drug: forodesine hydrochloride 600 mg / body/day (3 x 100 mg capsules twice daily)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, 460-0001, Japan
Nagoya Daini Red Cross Hospital
Nagoya, Aichi-ken, 466-8650, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280, Japan
Gunma University Hospital
Maebashi, Gunma, 371-8511, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804, Japan
Hyogo Cancer Center
Akashi, Hyōgo, 673-8558, Japan
Kensei Tobinai, MD,PhD
National Cancer Center Hospital
First Submitted
January 22, 2013
First Posted
January 28, 2013
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2016
Actual (reported)Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-refractory Chronic Lymphocytic Leukemia (CLL)
Contact the study team to confirm eligibility.
Tokai University Hospital
Isehara, Kanagawa, 259-1143, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Osaka University Hospital
Suita, Osaka, 565-0871, Japan
Shimane University Hospital
Izumo, Shimane, 693-8501, Japan
Tochigi Cancer Center
Utsunomiya, Tochigi, 320-0834, Japan
National Cancer Center Hospital
Chūō, Tokyo, 104-0045, Japan
The Cancer Institute Hospital Japanese Foundation for Cancer Research
Koto, Tokyo, 135-8550,, Japan
University of Fukui Hospital
Fukui, 910-1193, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
Imamura Bun-in Hospital
Kagoshima, 890-0064, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, 860-0008, Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, 602-8566, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Study Completion
April 26, 2017
Actual (reported)Last Updated
May 11, 2017
Record last verified: 2017-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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