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

NCT ID: NCT00419081

Last Updated: 2012-01-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2007-03-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Forodesine Hydrochloride Sterile Solution, 5 mg/mL

Intervention Type: DRUG

Forodesine Hydrochloride Capsules (100 mg)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with an unequivocal histologic diagnosis of precursor T-lymphoblastic leukemia/lymphoma (World Health Organization [WHO] classification).
• Failure to have responded to or relapsed after two or more treatment regimens for their disease, one of which could be HSCT.
• Performance status of 2 by Eastern Cooperative Oncology Group (ECOG) criteria (see Appendix A).
• Eighteen years of age and older.
• Life expectancy of at least three months.
• Adequate liver function (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT] ≤3 times upper limit of normal), unless related to the underlying leukemia.
• Negative serum or urine pregnancy test within two to seven days prior to the start of study treatment in females of childbearing potential.
• Females of childbearing potential and males must be willing and able to use an adequate method of contraception to avoid pregnancy for the duration of the study in such a manner that the risk of pregnancy is minimized. Acceptable contraceptives include intra-uterine devices (IUDs), hormonal contraceptives (oral, depot, patch, or injectable), and double-barrier methods such as condoms or diaphragms with spermicidal gel or foam.
• Signed informed consent form (ICF) prior to start of any study-specific procedures.
• Willing and able to provide authorization for the use and disclosure of personal health information in accordance with Health Insurance Portability and Accountability Act (HIPAA) policy (U.S. patients only).

Exclusion Criteria

• Patients with known human immunodeficiency virus (HIV) infection or human T lymphotrophic virus 1 (HTLV-1).
• Patients with active hepatitis B or C infection.
• Patients with clinical evidence of active central nervous system (CNS) leukemia.
• Active serious infection not controlled by oral or intravenous antibiotics.
• Patients with a calculated creatinine clearance of <50 mL/min.
• Prior treatment with any investigational antileukemic or chemotherapy agent within seven days prior to study entry or lack of full recovery from side effects due to prior therapy, independent of when that therapy was given.
• Rapidly progressive disease with compromised organ function judged to be life threatening by the Investigator.
• Concurrent treatment with other antileukemia agents (CNS prophylaxis [e.g., intrathecal methotrexate, cytarabine, or hydrocortisone] and corticosteroid use will not be excluded, but must first be approved by the Medical Monitor) (see Sections 9.2.1 and 9.2.2).
• Pregnant and/or lactating female.
• Patients who cannot swallow or who have chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the product.
• Hypersensitive or intolerant to any component of the study drug formulations.
• Patients who have received prior forodesine treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioCryst Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Auro del Giglio, MD

Role: PRINCIPAL_INVESTIGATOR

Faculdade de Medicina do ABC

Belinda Pinto Simoes, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital das Clinicas de Faculdade de Medicina de Ribeirao Preto

Carlos Sergio Chiattone, MD

Role: PRINCIPAL_INVESTIGATOR

Irmandade da Santa Casa de Misercordia de Sao Paulo

Carmino Antonio de Souza, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicias da UICAMP - Centro de Hematologia e Hemoterapia

David Barqueti Jendiroba, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Goiano de Oncologia

Ernesto de Meis, MD

Role: PRINCIPAL_INVESTIGATOR

INCA - Instituto Nacional de Cancer

Fernando Antonio Sellos Ribeiro, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Estadual de Hematologia Artur de Siqueira Cavalcanti - HEMORIO

Ines Guterres, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Nossa Senhora de Conceicao

Johnny Francisco Cordeiro Camargo, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Erasto Gaertner - Liga Paranaense de Combate ao Cancer - CEPEP

Jose Salvador Rodrigues Oliveira, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Santa Marcelina

Lucia Mariano da Rocha Silla, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas de Porto Alegre

Mair Pedro de Souza, MD

Role: PRINCIPAL_INVESTIGATOR

Fundacao Hospital Amaral Carvalho

Maria Aparecida Zanichelli, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Brigadeiro

Maria Lucia de Martino Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto de Oncologia Pediatrica - GRAACC Grupo de Apoio as Adolescente e a Crianca com Cancer - UNIFESP

Ricardo Pasquini, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas da Universidade Federal do Parana

Nicholas Novitzky, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Haematology

Vernon Louw, MD

Role: PRINCIPAL_INVESTIGATOR

Free State University

Farhad Ravandi, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Karen Seiter, MD

Role: PRINCIPAL_INVESTIGATOR

New York Medical College, Division of Oncology

Francesco Turturro, MD

Role: PRINCIPAL_INVESTIGATOR

Louisana State University Health Sciences Center

Luis Isola, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Wendy Stock, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago Hospital

Francisco Gonzalez, MD

Role: PRINCIPAL_INVESTIGATOR

Liberty Hematology and Oncology

James Foran, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Ellen Ritchie, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Leonard Heffner, MD

Role: PRINCIPAL_INVESTIGATOR

The Emory Clinic

Madan Jagasia, MD

Role: PRINCIPAL_INVESTIGATOR

The Vanderbilt University Medical Center

Katarzyna Jamieson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Gary Schiller, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Anjali Advani, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Kellie Sprague, MD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Tanya Trippett, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Meir Wetzler, MD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Alexander Gaiger, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University Hospital

Werner Linkersch, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Heamtology

David Nachbaur, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Heamatology

Agnes Buzin, MD

Role: PRINCIPAL_INVESTIGATOR

Stephane de Botton, MD

Role: PRINCIPAL_INVESTIGATOR

Jacques Delaunnay, MD

Role: PRINCIPAL_INVESTIGATOR

Herve Dombret, MD

Role: PRINCIPAL_INVESTIGATOR

Service Clinique des Maladies du Sang

Francoise Huguet-Rigal, MD

Role: PRINCIPAL_INVESTIGATOR

Service d'Hematologie

Norbert Ifrah, MD

Role: PRINCIPAL_INVESTIGATOR

Arnaud Pigneux, MD

Role: PRINCIPAL_INVESTIGATOR

CHU du Hart Leveque

Bruno Quesnel, MD

Role: PRINCIPAL_INVESTIGATOR

Houmedaly Reman, MD

Role: PRINCIPAL_INVESTIGATOR

Xavier Thomas, MD

Role: PRINCIPAL_INVESTIGATOR

Maladies du Sang

Norbert Vey, MD

Role: PRINCIPAL_INVESTIGATOR

Francis Witz, MD

Role: PRINCIPAL_INVESTIGATOR

Genadi Iosava, MD

Role: PRINCIPAL_INVESTIGATOR

Institute for Heamatology & Transfusiology

Mamia Zodelava, MD

Role: PRINCIPAL_INVESTIGATOR

Heamatology and Transfusiology Dept

Reinhard Andreesen, MD

Role: PRINCIPAL_INVESTIGATOR

Universitat Regensburg

Walter Aulitzky, MD

Role: PRINCIPAL_INVESTIGATOR

Innere Abt. II

Ulrich Duehrsen, MD

Role: PRINCIPAL_INVESTIGATOR

Gerhard Ehninger, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum Carl Gustav Carus der Technischen Universitat

Arnold Ganser, MD

Role: PRINCIPAL_INVESTIGATOR

ABT Hamatologie und Onkologie

R. Haas, MD

Role: PRINCIPAL_INVESTIGATOR

Universitatsklinik Dusseldorf

Dieter Hoelzer, MD

Role: PRINCIPAL_INVESTIGATOR

Leiterin der Studienzentrale

W-D Ludwig, MD

Role: PRINCIPAL_INVESTIGATOR

Charite Universitatsmedizin Berlin

Deiter Niederwieser, MD

Role: PRINCIPAL_INVESTIGATOR

Abt. Haematologie / Onkologie

Michael Pfreunschuh, MD

Role: PRINCIPAL_INVESTIGATOR

Medizinische Klinik I

Mathias Schmid, MD

Role: PRINCIPAL_INVESTIGATOR

Innere Medizin III, Hamatologie und Onkologie

Norbert Schmitz, MD

Role: PRINCIPAL_INVESTIGATOR

Hamatologsiche Abteilung

Peter Staib, MD

Role: PRINCIPAL_INVESTIGATOR

Med. Klinik I / Hamatolgie

Matthias Stelljes, MD

Role: PRINCIPAL_INVESTIGATOR

Innere Medizin A

Michele Baccarani, MD

Role: PRINCIPAL_INVESTIGATOR

Istitutp di Ematologia ed Oncologia Medica

Renato Bassan, MD

Role: PRINCIPAL_INVESTIGATOR

Dipartimento di Oncoloia ed Ematico

Alberto Bosi, MD

Role: PRINCIPAL_INVESTIGATOR

Aziendo Osperdaliero Universitaria Careggi Oncologia

Felicetto Ferrara, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera Antonio Cardarelli

Roberto Foa, MD

Role: PRINCIPAL_INVESTIGATOR

Cattedra di Ematologie

Eugenio Gallo, MD

Role: PRINCIPAL_INVESTIGATOR

Divisione di Ematologia

Vincenzo Liso, MD

Role: PRINCIPAL_INVESTIGATOR

UO Universita degi Studi Policinico Ematologia

Salvatore Mirto, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Osperdaliera Vincenzo Cervello Divisione

Enrica Morra, MD

Role: PRINCIPAL_INVESTIGATOR

Complessa di Ematologia and Dir Departmento

Enrico Pogliani, MD

Role: PRINCIPAL_INVESTIGATOR

Ematologia

Bob Lowenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Eramus University Medical Centre

Jerzy Holowiecki, MD

Role: PRINCIPAL_INVESTIGATOR

Klinika Hematologii I

Wieslaw Jedrzejczak, MD

Role: PRINCIPAL_INVESTIGATOR

Klinika Hematologii i Onkologii

Kazimierz Kuliczkowski, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Heamatology

Tadeusz Robak, MD

Role: PRINCIPAL_INVESTIGATOR

Klinika Hematologii Akademii Meduycznej Wojewodzki

Aleksander Skotnicki, MD

Role: PRINCIPAL_INVESTIGATOR

Katedra i Klinika Hematologii Collegium Medicum

K. Abdulkadyrov, MD

Role: PRINCIPAL_INVESTIGATOR

Head of Hematology Clinic

Anatoli Golenkov, MD

Role: PRINCIPAL_INVESTIGATOR

Head of Clinical Heam and Immunotherapy Dept.

S. Moiseev, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty Therapy Dept

Valerie Savchenko, MD

Role: PRINCIPAL_INVESTIGATOR

Dir. Research Institute for BMT and Molecular Hematology

J. Ribera, MD

Role: PRINCIPAL_INVESTIGATOR

Insitut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol

Locations

University of Chicago Medical Center

Chicago, Illinois, United States

Louisana State University Health Sciences Center

Shreveport, Louisiana, United States

New York Medical College Division of Oncology

Valhalla, New York, United States

Liberty Hematology and Oncology

Columbia, South Carolina, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

BCX1777-Tio-05-202

Identifier Type: -

Identifier Source: org_study_id