AzTrials
AzTrials

Lymphoma, Large-Cell, DiffusePhase 2NCT00498914

Study of YM155 in Refractory Diffuse Large B-cell Lymphoma (DLBCL) Subjects

A Phase 2 study testing YM155 in people with Lymphoma, Large-Cell, Diffuse and Lymphoma, B-Cell Refractory, run by Astellas Pharma Inc at 22 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

A study in subjects with a type of B cell lymphoma (DLBCL)to evaluate the response rate, efficacy, safety and tolerability of YM155 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
YM155
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
22 sitesin 4 countries
Study dates
Jun 2007to Apr 2009
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

  • Male or female subjects aged 18 years or older
  • Histologically confirmed primary DLBCL of any stage
  • Refractory to the last treatment regimen
  • Previously treated with the following treatment regimens:
  • Anthracycline-based combination chemotherapy with rituximab
  • Second-line combination chemotherapy
Show all 13Show fewer
  • Autologous BMT if the subject was eligible and did not refuse the procedure
  • At least one measurable lesion defined as > 1.5 cm in the longest diameter
  • No known central nervous system involvement
  • ECOG performance status < 2
  • Life expectancy > 12 weeks
  • If female, non-pregnant and non-lactating
  • IRB-approved consent and HIPAA Authorization

Who cannot join

  • Transformed, composite or discordant lymphoma
  • Therapy for lymphoma within 21 days prior to the first dose of YM155
  • Within 4 weeks of the screening FDG-PET scan, receipt of the following:
  • Radiation therapy
  • Surgical procedures (except biopsies and central catheter / port placement)
  • Active infection (bloodstream or deep tissue)
Show all 20Show fewer
  • Inadequate marrow, hepatic and/or renal function
  • Serum creatinine > 1.5 x ULN or calculated serum creatinine clearance < 60 mL/min
  • Absolute Neutrophil Count (ANC) < 750/mm3
  • Platelet < 50,000/mm3
  • Alanine Transaminase (ALT) and Aspartate Transaminase (AST) > 2.5 x ULN; > 5 x ULN if secondary to liver metastases
  • Treated with > 3 prior treatment regimens. The following should be considered:
  • Planned maintenance therapy should be considered as part of the previous treatment regimen
  • Any preparative treatment (salvage chemotherapy, high-dose chemotherapy, radiation therapy, etc.) should be included with the autologous BMT or PBSCT as one treatment
  • Prior allogeneic BMT or PBSCT
  • Previously treated with YM155
  • Other investigational therapy or procedures within 28 days
  • Known HIV, hepatitis B surface antigen, or hepatitis C antibody
  • Other malignancy requiring treatment within 2 years
  • Significant and/or uncontrolled cardiac, renal, hepatic, or other systemic disorders or significant psychological conditions that in the Investigator's judgment would jeopardize subject enrollment or compliance

Trial locations and contacts

22 sites in 4 countries.

22 sites in 4 countries

United States12 sites

  • Study site

    Atlanta, Georgia, 30322

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Beverly Hills, California, 90211

  • Study site

    Houston, Texas, 77303

  • Study site

    Miami, Florida, 33136

  • Study site

    Palo Alto, California, 94305

  • Study site

    Philadelphia, Pennsylvania, 19111

  • Study site

    Portland, Oregon, 97213

  • Study site

    San Antonio, Texas, 78229

  • Study site

    Shreveport, Louisiana, 71130

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Winston-Salem, North Carolina, 27157

Other trials in United States

France7 sites

  • Study site

    Bordeaux, 33076

  • Study site

    Montpellier, 34295

  • Study site

    Nantes, 44093

  • Study site

    Nice, 06200

  • Study site

    Poitiers, 86021

  • Study site

    Rouen, 76038

  • Study site

    Tours, 37044

Other trials in France

Spain2 sites

  • Study site

    Barcelona, 08035

  • Study site

    Madrid, 28041

Other trials in Spain

Canada1 site

  • Study site

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

About this study

Official title: A Phase II Multicenter, Open-Label Study of YM155 in Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Subjects

A study in subjects with a type of B cell lymphoma (DLBCL)to evaluate the response rate, efficacy, safety and tolerability of YM155

Read the detailed description

1 arm (Active), Phase 2 Study to evaluate response rate, efficacy, safety and tolerability of YM155

Being tested
YM155
Keywords
Lymphoma, Large-Cell, Diffuse, Lymphoma, B-Cell, YM155, Treatment outcomes, Refractory
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Lymphoma, B-Cell

What participants receive

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

  • YM155Drug

    Continuous IV infusion

Study groups in NCT00498914
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: YM155

What is being measured

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

  1. Overall response rate

    Measured: 15 treatment cycles

Secondary outcomes (1)

  1. Safety, efficacy, pharmacokinetics, and tolerability

    Measured: 15 treatment cycles

Timeline

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

  1. First posted11 Jul 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionApr 2009
  4. Study completionApr 2009

Why it stopped: Futility boundary at interim analysis not met

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
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00498914
Sponsor's protocol ID
155-CL-009
Other IDs
Eudra CT 2006-002584-70
Status last verified
Aug 2015
First submitted
10 Jul 2007
Last updated
4 Sep 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing YM155 in people with Lymphoma, Large-Cell, Diffuse and Lymphoma, B-Cell Refractory, run by Astellas Pharma Inc at 22 sites in 4 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 13 inclusion and 20 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: stopped early, as of the sponsor's last update on 4 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, France, Spain, Canada. 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 was stopped early (reason given: Futility boundary at interim analysis not met). Results are not available in the source record.

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?

Overall response rate (time frame: 15 treatment cycles). 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 NCT00498914.

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 4 Sep 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in