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

January 18, 2012 updated by: BioCryst Pharmaceuticals

A Phase IIb, Multicenter, Open-Label, Nonrandomized, Repeat-Dose Study of Forodesine Hydrochloride in Patients With Relapsed/Refractory Precursor T-Lymphoblastic Leukemia/Lymphoma Who Have Failed Two or More Prior Treatment Regimens.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Louisana State University Health Sciences Center
    • New York
      • Valhalla, New York, United States, 10595
        • New York Medical College Division of Oncology
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Liberty Hematology and Oncology
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BioCryst Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Meir Wetzler, MD, Roswell Park Cancer Institute
  • Principal Investigator: Gary Schiller, MD, University of California, Los Angeles
  • Principal Investigator: 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 Clínicas da Universidade Federal do Paraná
  • 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: Anjali Advani, MD, The Cleveland Clinic
  • Principal Investigator: Kellie Sprague, MD, Tufts Medical Center
  • 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, Universitätsklinik Düsseldorf
  • Principal Investigator: Dieter Hoelzer, MD, Leiterin der Studienzentrale
  • Principal Investigator: W-D Ludwig, MD, Charité Universitätsmedizin 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BCX1777-Tio-05-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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