Study of Forodesine Hydrochloride in Patients With Relapsed/Refractory Precursor T-Lymphoblastic Leukemia/Lymphoma Who Have Failed Two or More Prior Treatment Regimens

Summary

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.

Conditions

• Leukemia
• Lymphoma

Interventions

DRUG

Forodesine Hydrochloride Sterile Solution, 5 mg/mL

DRUG

Forodesine Hydrochloride Capsules (100 mg)

Sponsors & Collaborators

• BioCryst Pharmaceuticals

  lead INDUSTRY

Principal Investigators

• Auro del Giglio, MD · Faculdade de Medicina do ABC

• Belinda Pinto Simoes, MD · Hospital das Clinicas de Faculdade de Medicina de Ribeirao Preto

• Carlos Sergio Chiattone, MD · Irmandade da Santa Casa de Misercordia de Sao Paulo

• Carmino Antonio de Souza, MD · Hospital de Clinicias da UICAMP - Centro de Hematologia e Hemoterapia

• David Barqueti Jendiroba, MD · Centro Goiano de Oncologia

• Ernesto de Meis, MD · INCA - Instituto Nacional de Cancer

• Fernando Antonio Sellos Ribeiro, MD · Instituto Estadual de Hematologia Artur de Siqueira Cavalcanti - HEMORIO

• Ines Guterres, MD · Hospital Nossa Senhora de Conceicao

• Johnny Francisco Cordeiro Camargo, MD · Hospital Erasto Gaertner - Liga Paranaense de Combate ao Cancer - CEPEP

• Jose Salvador Rodrigues Oliveira, MD · Hospital Santa Marcelina

• Lucia Mariano da Rocha Silla, MD · Hospital de Clinicas de Porto Alegre

• Mair Pedro de Souza, MD · Fundacao Hospital Amaral Carvalho

• Maria Aparecida Zanichelli, MD · Hospital Brigadeiro

• Maria Lucia de Martino Lee, MD · Instituto de Oncologia Pediatrica - GRAACC Grupo de Apoio as Adolescente e a Crianca com Cancer - UNIFESP

• Ricardo Pasquini, MD · Hospital de Clinicas da Universidade Federal do Parana

• Nicholas Novitzky, MD · Division of Haematology

• Vernon Louw, MD · Free State University

• Farhad Ravandi, MD · M.D. Anderson Cancer Center

• Karen Seiter, MD · New York Medical College, Division of Oncology

• Francesco Turturro, MD · Louisana State University Health Sciences Center

• Luis Isola, MD · Icahn School of Medicine at Mount Sinai

• Wendy Stock, MD · University of Chicago Hospital

• Francisco Gonzalez, MD · Liberty Hematology and Oncology

• James Foran, MD · University of Alabama at Birmingham

• Ellen Ritchie, MD · Weill Medical College of Cornell University

• Leonard Heffner, MD · The Emory Clinic

• Madan Jagasia, MD · The Vanderbilt University Medical Center

• Katarzyna Jamieson, MD · University of Florida

• Gary Schiller, MD · University of California, Los Angeles

• Anjali Advani, MD · The Cleveland Clinic

• Kellie Sprague, MD · Tufts Medical Center

• Tanya Trippett, MD · Memorial Sloan Kettering Cancer Center

• Meir Wetzler, MD · Roswell Park Cancer Institute

• Alexander Gaiger, MD · Medical University Hospital

• Werner Linkersch, MD · Department of Heamtology

• David Nachbaur, MD · Department of Heamatology

• Agnes Buzin, MD

• Stephane de Botton, MD

• Jacques Delaunnay, MD

• Herve Dombret, MD · Service Clinique des Maladies du Sang

• Francoise Huguet-Rigal, MD · Service d'Hematologie

• Norbert Ifrah, MD

• Arnaud Pigneux, MD · CHU du Hart Leveque

• Bruno Quesnel, MD

• Houmedaly Reman, MD

• Xavier Thomas, MD · Maladies du Sang

• Norbert Vey, MD

• Francis Witz, MD

• Genadi Iosava, MD · Institute for Heamatology & Transfusiology

• Mamia Zodelava, MD · Heamatology and Transfusiology Dept

• Reinhard Andreesen, MD · Universitat Regensburg

• Walter Aulitzky, MD · Innere Abt. II

• Ulrich Duehrsen, MD

• Gerhard Ehninger, MD · Klinikum Carl Gustav Carus der Technischen Universitat

• Arnold Ganser, MD · ABT Hamatologie und Onkologie

• R. Haas, MD · Universitatsklinik Dusseldorf

• Dieter Hoelzer, MD · Leiterin der Studienzentrale

• W-D Ludwig, MD · Charite Universitatsmedizin Berlin

• Deiter Niederwieser, MD · Abt. Haematologie / Onkologie

• Michael Pfreunschuh, MD · Medizinische Klinik I

• Mathias Schmid, MD · Innere Medizin III, Hamatologie und Onkologie

• Norbert Schmitz, MD · Hamatologsiche Abteilung

• Peter Staib, MD · Med. Klinik I / Hamatolgie

• Matthias Stelljes, MD · Innere Medizin A

• Michele Baccarani, MD · Istitutp di Ematologia ed Oncologia Medica

• Renato Bassan, MD · Dipartimento di Oncoloia ed Ematico

• Alberto Bosi, MD · Aziendo Osperdaliero Universitaria Careggi Oncologia

• Felicetto Ferrara, MD · Azienda Ospedaliera Antonio Cardarelli

• Roberto Foa, MD · Cattedra di Ematologie

• Eugenio Gallo, MD · Divisione di Ematologia

• Vincenzo Liso, MD · UO Universita degi Studi Policinico Ematologia

• Salvatore Mirto, MD · Azienda Osperdaliera Vincenzo Cervello Divisione

• Enrica Morra, MD · Complessa di Ematologia and Dir Departmento

• Enrico Pogliani, MD · Ematologia

• Bob Lowenberg, MD · Eramus University Medical Centre

• Jerzy Holowiecki, MD · Klinika Hematologii I

• Wieslaw Jedrzejczak, MD · Klinika Hematologii i Onkologii

• Kazimierz Kuliczkowski, MD · Department of Heamatology

• Tadeusz Robak, MD · Klinika Hematologii Akademii Meduycznej Wojewodzki

• Aleksander Skotnicki, MD · Katedra i Klinika Hematologii Collegium Medicum

• K. Abdulkadyrov, MD · Head of Hematology Clinic

• Anatoli Golenkov, MD · Head of Clinical Heam and Immunotherapy Dept.

• S. Moiseev, MD · Faculty Therapy Dept

• Valerie Savchenko, MD · Dir. Research Institute for BMT and Molecular Hematology

• J. Ribera, MD · Insitut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-07-31

Primary Completion

2007-03-31

Completion

2007-03-31

Countries

• United States

Study Locations