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Cutaneous T-cell Lymphoma (CTCL),Phase 2NCT00501735

Forodesine in the Treatment of Cutaneous T-Cell Lymphoma

A Phase 2 study testing Forodesine 200 mg in people with Cutaneous T-cell Lymphoma (CTCL),, run by BioCryst Pharmaceuticals at 41 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a Phase II, non-randomized, open-label, single-arm trial that will be conducted at up to 50 sites in North America, Europe and Australia. This study is designed to assess objective response (OR) [complete response (CR) or partial response (PR)] in subjects with cutaneous manifestations of CTCL with a… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cutaneous T-cell Lymphoma (CTCL),
What is being tested?
Forodesine 200 mg
Type of treatment
Pill or oral medicine
How many people
144 participants
Where
41 sitesin 10 countries
Study dates
Jul 2007to Dec 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or non-pregnant females aged ≥18 years;
  • Histologically confirmed diagnosis of CTCL, including mycosis fungoides and/or Sezary syndrome, documentation of diagnosis by histologic examination should be available;
  • Subjects with CTCL stages IB, IIA, IIB, III, or IVA at the screening visit (i.e. stage refers to stage at study entry) and who have persistent, progressive, or recurrent disease during or following treatment with at least three forms of systemic therapy, one of which must have been oral bexarotene, unless treatment with oral bexarotene was not tolerated or was medically contraindicated;
  • Anticipated life expectancy greater than 6 months;
  • Performance status of 0, 1, or 2 by Eastern Cooperative Oncology Group (ECOG) criteria;
  • Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of study treatment;
  • Females of childbearing potential and sexually active males, if indicated, must be willing and able to use method(s) of contraception that are adequate to prevent or minimize the risk of pregnancy for the duration of the study;
  • Written informed consent to participate in the study.

Who cannot join

  • Proven or suspected extracutaneous visceral CTCL involvement (M1) (CTCL stage IVB) (note: presence of lymphadenopathy is permitted);
  • Previous treatment with Forodesine;
  • ECOG performance status >2;
  • Concomitant use of any anti-cancer therapy or immune modifier;
  • Concomitant use of any investigational agent or device;
  • Concurrent treatment with any other anti-CTCL therapy, or radiation therapy [topical corticosteroids (classes 1 and 2 prohibited) or low dose oral corticosteroids (≤10 mg/day prednisone or equivalent) will not be excluded, but if used, must be a stable dose and schedule during the four weeks immediately prior to study entry];
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  • Use of previous therapies for CTCL within the timeframes specified below:
  • Phototherapy in the previous 30 days;
  • Electron beam therapy, photopheresis, systemic anticancer therapy, interferon therapy, or other investigational therapy in the previous 30 days;
  • Oral retinoid (including bexarotene) in the previous 30 days
  • Alemtuzumab (Campath) or other monoclonal antibody within the previous 30 days
  • Vorinostat or other HDAC inhibitor within previous 30 days
  • Any investigational therapy within the previous 30 days;
  • ALT or AST >3 times ULN or alkaline phosphatase >2 times ULN;
  • Calculated creatinine clearance ≤50 mL/min or serum creatinine ≥1.8 mg/dL;
  • Serum potassium <3.3 mg/dL or >5.5 mg/dL;
  • Evidence of clinically significant (uncontrolled) hypo- or hyperthyroidism;
  • Recent (in past 6 months) medically significant cardiac event (i.e., myocardial infarction, cardiac surgery);
  • Presence of congestive heart failure (NYHA class IV) or angina (NYHA class IV) or presence of a medically significant dysrhythmia;
  • Presence of any of the following ECG findings:
  • Congenital long QT syndrome;
  • QTc interval >480 msec (Bazett's correction);
  • Presence of uncontrolled hypertension manifested by systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥90 mmHg;
  • Hemoglobin <9.0 gm/dL (intermittent red blood cell transfusions permitted);
  • Absolute neutrophil count <1500 cells/mm3;
  • Platelet count <75,000/mm3;
  • Requirement for neutrophil or platelet growth factor therapy or administration of such therapy in the previous 30 days;
  • CD4 count <200/mm3;
  • Documented current active infection with HIV, Hepatitis B, Hepatitis C, and/or CMV;
  • Presence of uncontrolled bacterial or viral infection (subject may be receiving chronic antimicrobial therapy); or,
  • History of culture-documented bacteremia in the previous 2 weeks;
  • Recent (i.e., in past 2 weeks) change in doses or regimens of medications used for any chronic non-oncologic condition for reasons of worsening of the chronic illness (change in doses of chronic medications associated with improvement in a chronic illness are not exclusionary);
  • Presence of any acute or chronic non-oncologic disease which, in the opinion of the investigator, is medically uncontrolled;
  • Coexistent second malignancy or history of prior malignancy within previous 5 years [excluding basal cell or squamous cell carcinoma of skin and cervical neoplasia (carcinoma-in-situ) that has been treated curatively]. Surgically resected nonmelanomatous skin cancer (non-CTCL) with no evidence of recurrence in previous 6 months is permitted; and,
  • Any significant medical or psychiatric condition that, in the opinion of the investigator, might prevent the subject from complying with all required study procedures.

Trial locations and contacts

41 sites in 10 countries.

41 sites in 10 countries

United States19 sites

  • Emory University

    Atlanta, Georgia, 30322

  • University of Alabama at Birmingham, Comprehensive Cancer Ctr

    Birmingham, Alabama, 35294-3300

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • University Hospitals Case Medical Center, Dept. of Dermatology

    Cleveland, Ohio, 44106

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Hackensack University Medical Ctr

    Hackensack, New Jersey, 07601

  • M.D. Anderson Cancer Center - Dermatology

    Houston, Texas, 77030

  • University of Wisconsin-Madison, Dept of Dermatology

    Madison, Wisconsin, 53715

  • Yale Cancer Center

    New Haven, Connecticut, 06520

  • Hospital at the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Hillman Cancer Ctr., University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Seattle Cancer Care Alliance

    Seattle, Washington, 89109

  • LSU Health Sciences Center, Feist-Weiller Cancer Center

    Shreveport, Louisiana, 71103

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford University Medical Center

    Stanford, California, 94305

  • Upstate Medical University

    Syracuse, New York, 13210

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Wake Forest University Health Sceinces, Dept. of Dermatology

    Winston-Salem, North Carolina, 27157

Other trials in United States

France6 sites

  • Hopital Hotel-Dieu

    Clermont-Ferrand, 63058

  • Creteil

    Créteil, 94000

  • Montpellier

    Montpellier, 34295

  • Pessac

    Pessac, 33600

  • CHU Robert Debre

    Reims, 51092

  • Toulouse

    Toulouse, 31059

Other trials in France

Italy5 sites

  • Bologna

    Bologna, 40138

  • Firenze

    Florence, 50121

  • Milan

    Milan, 20122

  • Rome

    Rome, 00167

  • Torino

    Torino, 10126

Other trials in Italy

Germany4 sites

  • Campus Charité Mitte

    Berlin, D10117

  • Universitatsklinikum Jena

    Jena, 07740

  • Universitat Kiel

    Kiel, 24105

  • Klinik fur Dermatologie, Venerologie und Allergologie

    Mannheim, 68163

Other trials in Germany

United Kingdom2 sites

  • London

    London, SE1 7EH

  • Manchester

    Manchester, M20 4BX

Other trials in United Kingdom

Australia1 site

  • Cabrini Hospital

    Malvern, Victoria, 3144

Other trials in Australia

Austria1 site

  • Wien

    Vienna, 1090

Other trials in Austria

Finland1 site

  • Helsinki

    Helsinki, FIN-00029 HUS

Other trials in Finland

Spain1 site

  • Madrid

    Madrid, 28041

Other trials in Spain

Switzerland1 site

  • Zurich

    Zurich, CH-8091

Other trials in Switzerland

About this study

Official title: Single Agent Phase II Study of Forodesine (BCX1777) in the Treatment of Cutaneous T-Cell Lymphoma

This is a Phase II, non-randomized, open-label, single-arm trial that will be conducted at up to 50 sites in North America, Europe and Australia. This study is designed to assess objective response (OR) [complete response (CR) or partial response (PR)] in subjects with cutaneous manifestations of CTCL with a requirement for maintenance of such objective response for at least 28 days in subjects with stage IIB, III, and IVA CTCL. Additionally, this study will evaluate the safety and tolerability of CTCL subjects Stages IB, IIA, IIB, III, or IVA treated with oral forodesine.

Being tested
Forodesine 200 mg
Keywords
T-Cell, Lymphoma, Forodesine, Mycosis Fungoides
Medical subject headings
Lymphoma, T-Cell, Cutaneous, Lymphoma, Mycosis Fungoides

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Forodesine 200 mgDrug

    2 x 100mg tablets once daily

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary objective of this study is to determine the objective response rate to treatment with oral forodesine in subjects with cutaneous manifestations of CTCL subjects, stages IIB, III, and IVA.

    Measured: Duration of Study

Secondary outcomes (5)

  1. Safety and tolerability

    Measured: Duration of Study

  2. Time to and duration of objective response in cutaneous manifestations

    Measured: Duration of Study

  3. Time to loss of objective response

    Measured: Duration of Study

  4. Objective response rate, time to and duration of extracutaneous manifestations

    Measured: Duration of Study

  5. Health related quality of life

    Measured: Duration of Study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionJul 2010
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00501735
Sponsor's protocol ID
BCX1777-203
Status last verified
Jan 2012
First submitted
12 Jul 2007
Last updated
23 Jan 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Dummer R, Duvic M, Scarisbrick J, Olsen EA, Rozati S, Eggmann N, Goldinger SM, Hutchinson K, Geskin L, Illidge TM, Giuliano E, Elder J, Kim YH. Final results of a multicenter phase II study of the purine nucleoside phosphorylase (PNP) inhibitor forodesine in patients with advanced cutaneous T-cell lymphomas (CTCL) (Mycosis fungoides and Sezary syndrome). Ann Oncol. 2014 Sep;25(9):1807-1812. doi: 10.1093/annonc/mdu231. Epub 2014 Jun 19.

    PubMed 24948692

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Forodesine 200 mg in people with Cutaneous T-cell Lymphoma (CTCL),, run by BioCryst Pharmaceuticals at 41 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, France, Italy, Germany, United Kingdom and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary objective of this study is to determine the objective response rate to treatment with oral forodesine in subjects with cutaneous manifestations of CTCL subjects, stages IIB, III, and IVA. (time frame: Duration of Study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00501735, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2012.

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