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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| Boston Children's Hospital | OTHER |
| National Cancer Institute (NCI) | NIH |
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This is a research study designed to look at the biological effects of two drugs on leukemia cells. In this study, we are comparing the effects of drugs called corticosteroids when used alone or with another drug called rapamycin. Rapamycin is a drug that prevents the body's immune system from working normally. It has been used for many years after kidney transplants to prevent rejection of the organ. Recent work suggests that rapamycin may also help treat leukemia and other cancers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Steroid Only | Active Comparator | Corticosteroid Alone |
|
| Steroid plus Rapamycin | Active Comparator | Corticosteroid plus Rapamycin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corticosteroid | Drug | Initial dose of corticosteroid given intravenously. After the first dose, corticosteroid will be taken orally every 8 hours for the duration of the five-day period |
| Measure | Description | Time Frame |
|---|---|---|
| Compare changes in gene expression signatures in steroid alone versus steroid plus rapamycin treated patients. | 3 years | |
| Compare biologic measures of "pro-apoptotic state" in steroid alone versus steroid plus rapamycin treated patients | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Assess clinical response by percent reduction of peripheral leukemia blasts at day 2 of therapy and at completion of the 5-day investigational window | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lewis Silverman, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D018942 | Macrolides |
| D007783 | Lactones |
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| Rapamycin | Drug | Taken orally mixed with water or orange juice |
|
|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |