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| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
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The purpose of this study is to determine if Revlimid will help maintain patients with acute myeloid leukemia in remission.
At present, the majority of AML patients >60 years of age that achieve CR and thereafter successfully complete further chemotherapy, are not candidates for allogeneic bone marrow transplantation (alloBMT) due to their age. Rather, this group of patients is simply observed until relapse occurs. In this age group, the median duration of CR is only ~10 months. The survival of patients <60 years of age who are not candidates for transplantation (due to donor unavailability), and who are in CR2 or higher is also extremely poor. Several lines of evidence suggest that the immune system - and in particular AML specific CTLs and NK cells - is capable of recognizing and clearing AML cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Arm A will receive Revlimid. |
|
| B | No Intervention | Arm B will not receive Revlimid but an observational arm |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revlimid | Drug | 10mgs PO daily for 21 days of each 28 day cycle. Number of cycles: total of 24 or until subject relapses or unacceptable toxicity develops. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the feasibility and assess the effect on relapse free survival by giving Revlimid in the post complete remission maintenance setting | The 1st interim analysis will be done once all subjects have completed 12 cycles, and the 2nd interim analysis will be done once all subjects have completed treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the toxicity of Revlimid when given in the maintenance setting. | The 1st interim analysis will be done after all subjects have receieved 12 cycles and the 2nd when all subjects have completed treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andre Schuh, MD.FRCP(C) | University Health Network Princess Margaret Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network, Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |