A Study of YM155 Plus Rituximab in Subjects With Non-Hodgkin's Lymphoma Who Have Received Prior Treatment
This study is ongoing, but not recruiting participants.
Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01007292
First received: September 24, 2009
Last updated: April 11, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkin's Lymphoma |
Drug: YM155 Biological: Rituximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Confirmed Complete remission rate [ Time Frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment ] [ Designated as safety issue: No ]
- Confirmed Partial remission rate [ Time Frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment ] [ Designated as safety issue: No ]
- Time to response [ Time Frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment ] [ Designated as safety issue: No ]
- Clinical benefit rate [ Time Frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 1 year after the last subject completes treatment ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 43 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | December 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: YM155 plus rituximab |
Drug: YM155
intravenous infusion
Biological: Rituximab
intravenous infusion
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01007292
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294-3300 | |
| United States, Connecticut | |
| Yale Cancer Center | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Georgia | |
| John B. Amos Cancer Center | |
| Columbus, Georgia, United States, 31904 | |
| United States, Illinois | |
| Loyola University Hospital | |
| Maywood, Illinois, United States, 60153 | |
| United States, New York | |
| Mount Sinai Hospital | |
| New York, New York, United States, 10029 | |
| United States, North Carolina | |
| Blumenthal Cancer Center Oncology Research | |
| Charlotte, North Carolina, United States, 28204 | |
| United States, Ohio | |
| Gabrail Cancer Center | |
| Canton, Ohio, United States, 44718 | |
| United States, Texas | |
| CTRC at The University of Texas Health Science Center | |
| San Antonio, Texas, United States, 78229 | |
| France | |
| Institut Bergonie | |
| Bordeaux-cedex, France, 33076 | |
| Service hématologie Clinique | |
| Nantes, France, 44093 | |
| Hopital de I'Archet 1 | |
| Nice, France, 6200 | |
| Centre Antoine Lacassagne | |
| Nice, France, 06189 | |
| Hopital Saint Louis | |
| Paris, France, 75475 | |
| Centre Henri Becquerel | |
| Rouen, France, 76038 | |
| Hopital Bretonneau | |
| Tours, France, 37044 | |
| Hôpital D'Adultes de Brabois | |
| Vandoeuvre, France, 54550 | |
| Spain | |
| Hospital del Mar | |
| Barcelona, Spain, 08003 | |
| Hospital Universitario Ramon y Cajal | |
| Madrid, Spain, 28034 | |
| Hospital Universitario Ramon y Cajal | |
| Madrid, Spain, 28006 | |
| Hospital Universitario Madrid Sanchinarro | |
| Madrid, Spain, 28050 | |
| Hospital Universitario de Salamanca | |
| Salamanca, Spain, 37007 | |
| United Kingdom | |
| Addenbrookes Hospital | |
| Cambridge, United Kingdom, CB2 0QQ | |
| St George's Healthcare NHS Trust | |
| London, United Kingdom, SW17 0QT | |
| The Christie NHS Foundation Trust | |
| Manchester, United Kingdom, M20 4BX | |
| ORH Level 2 Cancer and Haematology Centre | |
| Oxford, United Kingdom, OX3 7LJ | |
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
| Study Director: | Senior Medical Director | Astellas Pharma Global Development |
More Information
No publications provided
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT01007292 History of Changes |
| Other Study ID Numbers: | 155-CL-031 |
| Study First Received: | September 24, 2009 |
| Last Updated: | April 11, 2013 |
| Health Authority: | United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Spain: Spanish Agency of Medicines |
Keywords provided by Astellas Pharma Inc:
|
Non-Hodgkin's Lymphoma relapsed CD20-Positive YM155 |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 18, 2013