Non-Hodgkin's LymphomaPhase 2NCT01007292
A Study of YM155 Plus Rituximab in Subjects With Non-Hodgkin's Lymphoma Who Have Received Prior Treatment
A Phase 2 study testing YM155 and Rituximab in people with Non-Hodgkin's Lymphoma, run by Astellas Pharma Inc at 19 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate response rate, survival, safety and tolerability of YM155 given in combination with rituximab in subjects with Non-Hodgkin's Lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- YM155 and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 19 sitesin 4 countries
- Study dates
- Nov 2009to Jun 2015
- 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
- Any stage, histologically confirmed CD20-positive primary or transformed diffuse large B cell lymphoma (DLBCL)or grade 3 follicular lymphoma (FL)
- Ineligible for or have previously received an autologous stem cell transplant (ASCT)
- Relapsed following receipt of the last dose of systemic chemotherapy or ASCT
- At least one prior chemotherapy regimen. Prior chemotherapy regimen must have contained anthracycline (unless contraindicated)
- If the subject is female, she must be non-pregnant and non-lactating at the Baseline Visit. All sexually active males and females of childbearing potential must agree to use an adequate method of contraception throughout the study period
- Eastern Cooperative Oncology Group (ECOG) performance status </= 1
Who cannot join
- Use of any standard/experimental anti-lymphoma drug therapy within 21 days of the Baseline Visit
- Use of systemic steroids within 5 days of the Baseline Visit (except for the purposes of pre-medication prior to study regimen treatment)
- Prior allogeneic stem cell transplant (SCT)
- The subject has been previously treated with YM155
- The subject has known human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibody
- The subject has received other investigational therapy or procedures within 21 days prior to the first study drug administration
Trial locations and contacts
19 sites in 4 countries.
19 sites in 4 countries
United States6 sites
Site US2149 Gabrail Cancer Center Research
Canton, Ohio, 44718
Site US2802 Mecklenburg Medical Group
Charlotte, North Carolina, 28204
Site US2778 John B. Amos Cancer Center
Columbus, Georgia, 31904
Site US55 Loyola University Hospital - Maywood
Maywood, Illinois, 60153
Site US9 Mount Sinai School of Medicine
New York, New York, 10029
Site US402 University of Texas Health Science Center - San Antonio
San Antonio, Texas, 78229
France5 sites
Site FR1926 Institut Bergonie
Bordeaux, 33076
Site FR2700 Centre Antoine Lacassagne
Nice, 06189
Site FR476 Hopital Saint Louis
Paris, 75475
Site FR1889 Centre de Lutte Contre le Cancer - Centre Henri Becquerel
Rouen, 76038
Site FR1897 Hopital Bretonneau
Tours, 37044
Spain4 sites
Site ES1349 Hospital del Mar
Barcelona, 08003
Site ES1339 Hospital Universitario Ramon y Cajal
Madrid, 28034
Site ES2967 Hosptial Universitario Madrid Sanchinarro
Madrid, 28050
Site ES1346 Hospital Universitario de Salamanca
Salamanca, 37007
United Kingdom4 sites
Site GB2702 Addenbrookes Hospital
Cambridge, CB2 0QQ
Site GB1928 St. Georges Hospital
London, SW17 0QT
Site GB2624 The Christie NHS Foundation Trust
Manchester, M20 4BX
Site GB1903 Oxford Radcliffe Hospital
Oxford, OX3 7LJ
About this study
Official title: A Phase II, Multicenter, Open-Label Study Of YM155 Plus Rituximab In Previously Treated Subjects With CD20-Positive B Cell Non-Hodgkin's Lymphoma Who Are Ineligible For Or Have Previously Received An Autologous Stem Cell Transplant
The purpose of this study is to evaluate response rate, survival, safety and tolerability of YM155 given in combination with rituximab in subjects with Non-Hodgkin's Lymphoma.
Read the detailed description
This is an outpatient study. All subjects enrolled in this study will receive YM155 and rituximab given during 14 day cycles. Each subject will be assessed at the end of each cycle to determine if he or she may continue to the next cycle. Each subject will be eligible to continue receiving the combination regimen in this study until one of the discontinuation criteria is met.
If a subject discontinues treatment without progressive disease (PD) that subject will complete follow-up visits every 12 weeks for 1 year or until initiating another systemic anti-lymphoma treatment, exhibiting PD, or death.
Each subject will be contacted by the study site every 12 weeks for survival following the End of Treatment Visit. The contacts will continue until death or for no more than 1 year.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- YM155, Rituximab
- Keywords
- Non-Hodgkin's Lymphoma, relapsed, CD20-Positive, YM155
- Medical subject headings
- Lymphoma, Non-Hodgkin, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM155Drug
intravenous infusion
RituximabBiological
Also called Rituxan, Mabthera
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| YM155 plus rituximab | Experimental | Not described Receives: Drug: YM155; Biological: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (Confirmed Complete Remission +Confirmed Partial Remission)
Measured: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Secondary outcomes (8)
Confirmed Complete remission rate
Measured: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Confirmed Partial remission rate
Measured: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Time to response
Measured: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Duration of response
Measured: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Clinical benefit rate
Measured: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Progression-free survival
Measured: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Overall survival
Measured: 1 year after the last subject completes treatment
Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)
Measured: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2013
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Medical Director, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007292
- Sponsor's protocol ID
- 155-CL-031
- Status last verified
- Sep 2015
- First submitted
- 24 Sep 2009
- Last updated
- 19 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Open-Label Study Of YM155 Plus Rituximab In Previously Treated Subjects With CD20-Positive B Cell Non-Hodgkin's Lymphoma Who Are Ineligible For Or Have Previously Received An Autologous Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT01007292
- Acronym / sponsor ID
- 155-CL-031
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- Non-Hodgkin's Lymphoma, relapsed, CD20-Positive, YM155
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 4 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate response rate, survival, safety and tolerability of YM155 given in combination with rituximab in subjects with Non-Hodgkin's Lymphoma.
Detailed description
This is an outpatient study. All subjects enrolled in this study will receive YM155 and rituximab given during 14 day cycles. Each subject will be assessed at the end of each cycle to determine if he or she may continue to the next cycle. Each subject will be eligible to continue receiving the combination regimen in this study until one of the discontinuation criteria is met.
If a subject discontinues treatment without progressive disease (PD) that subject will complete follow-up visits every 12 weeks for 1 year or until initiating another systemic anti-lymphoma treatment, exhibiting PD, or death.
Each subject will be contacted by the study site every 12 weeks for survival following the End of Treatment Visit. The contacts will continue until death or for no more than 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YM155 plus rituximab | Experimental | Drug: YM155, Biological: Rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Any stage, histologically confirmed CD20-positive primary or transformed diffuse large B cell lymphoma (DLBCL)or grade 3 follicular lymphoma (FL)
- Ineligible for or have previously received an autologous stem cell transplant (ASCT)
- Relapsed following receipt of the last dose of systemic chemotherapy or ASCT
- At least one prior chemotherapy regimen. Prior chemotherapy regimen must have contained anthracycline (unless contraindicated)
- If the subject is female, she must be non-pregnant and non-lactating at the Baseline Visit. All sexually active males and females of childbearing potential must agree to use an adequate method of contraception throughout the study period
Key exclusion criteria (6 listed)
- Use of any standard/experimental anti-lymphoma drug therapy within 21 days of the Baseline Visit
- Use of systemic steroids within 5 days of the Baseline Visit (except for the purposes of pre-medication prior to study regimen treatment)
- Prior allogeneic stem cell transplant (SCT)
- The subject has been previously treated with YM155
- The subject has known human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibody
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YM155intravenous infusion | Drug | YM155 plus rituximab |
| RituximabAlso: Rituxan, Mabtheraintravenous infusion | Biological | YM155 plus rituximab |
Primary outcome
Objective response rate (Confirmed Complete Remission +Confirmed Partial Remission)
Time frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
8 secondary outcomes
Confirmed Complete remission rate
Time frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Confirmed Partial remission rate
Time frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Time to response
Time frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Duration of response
Time frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Clinical benefit rate
Time frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Progression-free survival
Time frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Overall survival
Time frame: 1 year after the last subject completes treatment
Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)
Time frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Senior Medical Director study director
Astellas Pharma Global Development
19 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YM155 and Rituximab in people with Non-Hodgkin's Lymphoma, run by Astellas Pharma Inc at 19 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 6 inclusion and 6 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 19 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, France, Spain, United Kingdom. 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?
Objective response rate (Confirmed Complete Remission +Confirmed Partial Remission) (time frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2015.