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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YM155 plus rituximab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YM155 | Drug | intravenous infusion |
| |
| Rituximab |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (Confirmed Complete Remission +Confirmed Partial Remission) | After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Complete remission rate | After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment | |
| Confirmed Partial remission rate | After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Senior Medical Director | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site US2778 John B. Amos Cancer Center | Columbus | Georgia | 31904 | United States | ||
| Site US55 Loyola University Hospital - Maywood |
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| Biological |
intravenous infusion |
|
|
| Time to response | After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment |
| Duration of response | After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment |
| Clinical benefit rate | After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment |
| Progression-free survival | After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment |
| Overall survival | 1 year after the last subject completes treatment |
| Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs) | After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment |
| Maywood |
| Illinois |
| 60153 |
| United States |
| Site US9 Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Site US2802 Mecklenburg Medical Group | Charlotte | North Carolina | 28204 | United States |
| Site US2149 Gabrail Cancer Center Research | Canton | Ohio | 44718 | United States |
| Site US402 University of Texas Health Science Center - San Antonio | San Antonio | Texas | 78229 | United States |
| Site FR1926 Institut Bergonie | Bordeaux | 33076 | France |
| Site FR2700 Centre Antoine Lacassagne | Nice | 06189 | France |
| Site FR476 Hopital Saint Louis | Paris | 75475 | France |
| Site FR1889 Centre de Lutte Contre le Cancer - Centre Henri Becquerel | Rouen | 76038 | France |
| Site FR1897 Hopital Bretonneau | Tours | 37044 | France |
| Site ES1349 Hospital del Mar | Barcelona | 08003 | Spain |
| Site ES1339 Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Site ES2967 Hosptial Universitario Madrid Sanchinarro | Madrid | 28050 | Spain |
| Site ES1346 Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Site GB2702 Addenbrookes Hospital | Cambridge | CB2 0QQ | United Kingdom |
| Site GB1928 St. Georges Hospital | London | SW17 0QT | United Kingdom |
| Site GB2624 The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Site GB1903 Oxford Radcliffe Hospital | Oxford | OX3 7LJ | United Kingdom |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C523798 | sepantronium |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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