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

NCT00419081 | Terminated Phase 2

• 1 other identifier: BCX1777-Tio-05-202
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

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

Keywords

leukemia; lymphoma

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (8)

• To determine the rate of CR achieved based on prior HSCT status

• Assess safety and tolerability

• Assess survival end points

• Evaluate the maintenance and duration of response

• Evaluate the proportion of patients able to proceed to HSCT

Interventions

Forodesine Hydrochloride Sterile Solution, 5 mg/mL DRUG

Forodesine Hydrochloride Capsules (100 mg) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioCryst Pharmaceuticals: lead

Study Sites (5)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Louisana State University Health Sciences Center

Shreveport, Louisiana, 71103, United States

Location

New York Medical College Division of Oncology

Valhalla, New York, 10595, United States

Location

Liberty Hematology and Oncology

Columbia, South Carolina, 29203, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Leukemia; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• 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

  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 Català d'Oncologia-Hospital Universitari Germans Trias i Pujol

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2007
• First Posted: January 8, 2007
• Study Start: July 1, 2006
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: January 23, 2012

Record last verified: 2012-01

Locations

US (5)