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Issues with Manufacturing
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The purpose of this study is to determine whether Forodesine Hydrochloride is effective in treating patients with relapsed/refractory precursor T-Lymphoblastic Leukemia/Lymphoma who have failed two or more prior treatment regimens.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Forodesine Hydrochloride Sterile Solution, 5 mg/mL | Drug | |||
| Forodesine Hydrochloride Capsules (100 mg) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the rate of complete remission for T lymphoblastic leukemia/lymphoma relapsed or refractory patients. The complete remission rate will be evaluated over the three-month Initial Treatment Period. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the rate of CR achieved based on prior HSCT status | ||
| Assess safety and tolerability | ||
| Assess survival end points |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Auro del Giglio, MD | Faculdade de Medicina do ABC | Principal Investigator |
| Belinda Pinto Simoes, MD | Hospital das Clinicas de Faculdade de Medicina de Ribeirao Preto | Principal Investigator |
| Carlos Sergio Chiattone, MD | Irmandade da Santa Casa de Misercordia de Sao Paulo | Principal Investigator |
| Carmino Antonio de Souza, MD | Hospital de Clinicias da UICAMP - Centro de Hematologia e Hemoterapia | Principal Investigator |
| David Barqueti Jendiroba, MD | Centro Goiano de Oncologia | Principal Investigator |
| Ernesto de Meis, MD | INCA - Instituto Nacional de Cancer | Principal Investigator |
| Fernando Antonio Sellos Ribeiro, MD | Instituto Estadual de Hematologia Artur de Siqueira Cavalcanti - HEMORIO | Principal Investigator |
| Ines Guterres, MD | Hospital Nossa Senhora de Conceicao | Principal Investigator |
| Johnny Francisco Cordeiro Camargo, MD | Hospital Erasto Gaertner - Liga Paranaense de Combate ao Cancer - CEPEP |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States | ||
| Louisana State University Health Sciences Center |
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| Evaluate the maintenance and duration of response |
| Evaluate the proportion of patients able to proceed to HSCT |
| Evaluate the effects of this forodesine regimen on plasma levels of dGuo |
| Determine the effects of this forodesine regimen on clinical end points |
| Explore potential predictive biomarkers |
| Principal Investigator |
| Jose Salvador Rodrigues Oliveira, MD | Hospital Santa Marcelina | Principal Investigator |
| Lucia Mariano da Rocha Silla, MD | Hospital de Clinicas de Porto Alegre | Principal Investigator |
| Mair Pedro de Souza, MD | Fundacao Hospital Amaral Carvalho | Principal Investigator |
| Maria Aparecida Zanichelli, MD | Hospital Brigadeiro | Principal Investigator |
| Maria Lucia de Martino Lee, MD | Instituto de Oncologia Pediatrica - GRAACC Grupo de Apoio as Adolescente e a Crianca com Cancer - UNIFESP | Principal Investigator |
| Ricardo Pasquini, MD | Hospital de Clinicas da Universidade Federal do Parana | Principal Investigator |
| Nicholas Novitzky, MD | Division of Haematology | Principal Investigator |
| Vernon Louw, MD | Free State University | Principal Investigator |
| Farhad Ravandi, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Karen Seiter, MD | New York Medical College, Division of Oncology | Principal Investigator |
| Francesco Turturro, MD | Louisana State University Health Sciences Center | Principal Investigator |
| Luis Isola, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Wendy Stock, MD | University of Chicago Hospital | Principal Investigator |
| Francisco Gonzalez, MD | Liberty Hematology and Oncology | Principal Investigator |
| James Foran, MD | University of Alabama at Birmingham | Principal Investigator |
| Ellen Ritchie, MD | Weill Medical College of Cornell University | Principal Investigator |
| Leonard Heffner, MD | The Emory Clinic | Principal Investigator |
| Madan Jagasia, MD | The Vanderbilt University Medical Center | Principal Investigator |
| Katarzyna Jamieson, MD | University of Florida | Principal Investigator |
| Gary Schiller, MD | University of California, Los Angeles | Principal Investigator |
| Anjali Advani, MD | The Cleveland Clinic | Principal Investigator |
| Kellie Sprague, MD | Tufts Medical Center | Principal Investigator |
| Tanya Trippett, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Meir Wetzler, MD | Roswell Park Cancer Institute | Principal Investigator |
| Alexander Gaiger, MD | Medical University Hospital | Principal Investigator |
| Werner Linkersch, MD | Department of Heamtology | Principal Investigator |
| David Nachbaur, MD | Department of Heamatology | Principal Investigator |
| Agnes Buzin, MD | Principal Investigator |
| Stephane de Botton, MD | Principal Investigator |
| Jacques Delaunnay, MD | Principal Investigator |
| Herve Dombret, MD | Service Clinique des Maladies du Sang | Principal Investigator |
| Francoise Huguet-Rigal, MD | Service d'Hematologie | Principal Investigator |
| Norbert Ifrah, MD | Principal Investigator |
| Arnaud Pigneux, MD | CHU du Hart Leveque | Principal Investigator |
| Bruno Quesnel, MD | Principal Investigator |
| Houmedaly Reman, MD | Principal Investigator |
| Xavier Thomas, MD | Maladies du Sang | Principal Investigator |
| Norbert Vey, MD | Principal Investigator |
| Francis Witz, MD | Principal Investigator |
| Genadi Iosava, MD | Institute for Heamatology & Transfusiology | Principal Investigator |
| Mamia Zodelava, MD | Heamatology and Transfusiology Dept | Principal Investigator |
| Reinhard Andreesen, MD | Universitat Regensburg | Principal Investigator |
| Walter Aulitzky, MD | Innere Abt. II | Principal Investigator |
| Ulrich Duehrsen, MD | Principal Investigator |
| Gerhard Ehninger, MD | Klinikum Carl Gustav Carus der Technischen Universitat | Principal Investigator |
| Arnold Ganser, MD | ABT Hamatologie und Onkologie | Principal Investigator |
| R. Haas, MD | Universitatsklinik Dusseldorf | Principal Investigator |
| Dieter Hoelzer, MD | Leiterin der Studienzentrale | Principal Investigator |
| W-D Ludwig, MD | Charite Universitatsmedizin Berlin | Principal Investigator |
| Deiter Niederwieser, MD | Abt. Haematologie / Onkologie | Principal Investigator |
| Michael Pfreunschuh, MD | Medizinische Klinik I | Principal Investigator |
| Mathias Schmid, MD | Innere Medizin III, Hamatologie und Onkologie | Principal Investigator |
| Norbert Schmitz, MD | Hamatologsiche Abteilung | Principal Investigator |
| Peter Staib, MD | Med. Klinik I / Hamatolgie | Principal Investigator |
| Matthias Stelljes, MD | Innere Medizin A | Principal Investigator |
| Michele Baccarani, MD | Istitutp di Ematologia ed Oncologia Medica | Principal Investigator |
| Renato Bassan, MD | Dipartimento di Oncoloia ed Ematico | Principal Investigator |
| Alberto Bosi, MD | Aziendo Osperdaliero Universitaria Careggi Oncologia | Principal Investigator |
| Felicetto Ferrara, MD | Azienda Ospedaliera Antonio Cardarelli | Principal Investigator |
| Roberto Foa, MD | Cattedra di Ematologie | Principal Investigator |
| Eugenio Gallo, MD | Divisione di Ematologia | Principal Investigator |
| Vincenzo Liso, MD | UO Universita degi Studi Policinico Ematologia | Principal Investigator |
| Salvatore Mirto, MD | Azienda Osperdaliera Vincenzo Cervello Divisione | Principal Investigator |
| Enrica Morra, MD | Complessa di Ematologia and Dir Departmento | Principal Investigator |
| Enrico Pogliani, MD | Ematologia | Principal Investigator |
| Bob Lowenberg, MD | Eramus University Medical Centre | Principal Investigator |
| Jerzy Holowiecki, MD | Klinika Hematologii I | Principal Investigator |
| Wieslaw Jedrzejczak, MD | Klinika Hematologii i Onkologii | Principal Investigator |
| Kazimierz Kuliczkowski, MD | Department of Heamatology | Principal Investigator |
| Tadeusz Robak, MD | Klinika Hematologii Akademii Meduycznej Wojewodzki | Principal Investigator |
| Aleksander Skotnicki, MD | Katedra i Klinika Hematologii Collegium Medicum | Principal Investigator |
| K. Abdulkadyrov, MD | Head of Hematology Clinic | Principal Investigator |
| Anatoli Golenkov, MD | Head of Clinical Heam and Immunotherapy Dept. | Principal Investigator |
| S. Moiseev, MD | Faculty Therapy Dept | Principal Investigator |
| Valerie Savchenko, MD | Dir. Research Institute for BMT and Molecular Hematology | Principal Investigator |
| J. Ribera, MD | Insitut CatalĂ d'Oncologia-Hospital Universitari Germans Trias i Pujol | Principal Investigator |
| Shreveport |
| Louisiana |
| 71103 |
| United States |
| New York Medical College Division of Oncology | Valhalla | New York | 10595 | United States |
| Liberty Hematology and Oncology | Columbia | South Carolina | 29203 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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