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| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
| Beth Israel Deaconess Medical Center | OTHER |
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The purpose of this study is to determine the safety of parathyroid hormone in combination with G-CSF when used as a stem cell mobilization regimen for patients who fail to mobilize sufficient progenitor stem cells after one or two attempts.
Patients will start treatment within 21 days of the determination of inadequate mobilization. PTH treatment will be given in 4 cohorts: 40 mcg, 60 mcg, 80 mcg, and 10 mcg. PTH will be given on day 1 and continue until stem cell collections are complete or a maximum of 20 days. G-CSF 10 mcg/kg will be given on days 10-14 and continue until stem cell collections are complete. Patients with inadequate CD34+ cells on Day 14 will meet off study criteria and not continue with PTH/G-CSF.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stem cell mobilization | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To assess safety of parathyroid hormone in combination with G-CSF when used as a mobilization agent at four different dosing levels. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the peripheral blood CD34+ count after second mobilization. | ||
| To evaluate CD34+ cells/kg from apheresis after second mobilization. | ||
| To evaluate the percent of patients for whom adequate numbers of CD34+ cells are obtained. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Ballen, M.D. | Massachusetts General Hospital, Harvard University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States | ||
| Massachusetts General Hospital |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D019650 | Hematopoietic Stem Cell Mobilization |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| To evaluate transfusion support. |
| To evaluate the days to neutrophil engraftment (ANC >500) post autologous transplant. |
| To evaluate the days to platelet engraftment (platelet count > 20,000 unsupported). |
| Boston |
| Massachusetts |
| 02116 |
| United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |