Clinical Evaluation of Nelarabine (506U78)in Japanese Patients With Leukemia or Lymphoma
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ClinicalTrials.gov Identifier: NCT00406757 |
Recruitment Status
:
Completed
First Posted
: December 4, 2006
Last Update Posted
: November 13, 2017
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Tracking Information | ||||
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First Submitted Date ICMJE | November 30, 2006 | |||
First Posted Date ICMJE | December 4, 2006 | |||
Last Update Posted Date | November 13, 2017 | |||
Actual Study Start Date ICMJE | August 30, 2006 | |||
Actual Primary Completion Date | July 15, 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Adverse events, changes from baseline in physical examination and clinical laboratory parameters12-lead ECGAssessment of pharmacokinetic endpoints of 506U78, ara-G and intracellular ara-GTP concentration. [ Time Frame: Day 21 ] | |||
Original Primary Outcome Measures ICMJE |
Adverse events Changes from baseline in physical examination and clinical laboratory parameters 12-lead ECG Assessment of pharmacokinetic endpoints of 506U78, ara-G and intracellular ara-GTP concentration. | |||
Change History | Complete list of historical versions of study NCT00406757 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Evaluation of response (e.g., CR, CR*) in patients with bone marrow involvement. [ Time Frame: Day 21 ] | |||
Original Secondary Outcome Measures ICMJE |
Evaluation of response (e.g., CR, CR*) in patients with bone marrow involvement. | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Clinical Evaluation of Nelarabine (506U78)in Japanese Patients With Leukemia or Lymphoma | |||
Official Title ICMJE | Clinical Evaluation of 506U78 in Japanese Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma. | |||
Brief Summary | In Japan, patients with relapsed or refractory T-ALL/T-LBL represent an extremely small patient population. While the small number of patients presents a practical limitation to the size of a clinical trial, patients whose disease has not responded to or has relapsed after treatment with multiple prior chemotherapy regimens have no accepted standard therapies available. Japanese leukemia experts have expressed interest in evaluating 506U78 in Japanese patients with relapsed or refractory T-ALL/T-LBL. In order to obtain safety, tolerability, and pharmacokinetic data of 506U78 in Japanese patients, this study is designed to maximize the contribution of each available patient. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Leukaemia, Lymphoblastic, Acute and Lymphoma, Lymphoblastic | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Horibe K, Takimoto T, Yokozawa T, Makimoto A, Kobayashi Y, Ogawa C, Ohno R, Koh N, Katsura K, Tobinai K. [Phase I study of nelarabine in patients with relapsed or refractory T-ALL/T-LBL]. Rinsho Ketsueki. 2011 Jun;52(6):406-15. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
13 | |||
Original Enrollment ICMJE |
12 | |||
Actual Study Completion Date | July 15, 2009 | |||
Actual Primary Completion Date | July 15, 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | up to 64 Years (Child, Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00406757 | |||
Other Study ID Numbers ICMJE | PGA105446 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | GlaxoSmithKline | |||
Study Sponsor ICMJE | GlaxoSmithKline | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | GlaxoSmithKline | |||
Verification Date | November 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |