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| Sponsored by: |
GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00406757 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma |
Drug: Nelarabine (506U78) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
| Official Title: | Clinical Evaluation of 506U78 in Japanese Patients With Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia or T-Cell Lymphoblastic Lymphoma. |
| Estimated Enrollment: | 12 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | June 2008 |
| Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | up to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
| Japan | |
| GSK Investigational Site | Recruiting |
| Tokyo, Japan, 104-0045 | |
| GSK Investigational Site | Recruiting |
| Aichi, Japan, 460-0001 | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | PGA105446 |
| Study First Received: | November 30, 2006 |
| Last Updated: | October 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00406757 History of Changes |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
|
T-ALL T-LBL T-cell 506U78 |
Leukemia Lymphoma ara-G ara-GTP |
|
Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoblastic Lymphoma Lymphoma Acute Lymphoblastic Leukemia |
|
Lymphatic Diseases Leukemia Neoplasms Leukemia, Lymphoid Immunoproliferative Disorders Neoplasms by Histologic Type |
Precursor Cell Lymphoblastic Leukemia-Lymphoma Immune System Diseases Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |