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This trial will evaluate the safety and efficacy of RIC HIDT transplant protocol following fludarabine and intermediate-dose TBI 800 cGy utilizing PBSC as the stem cell source.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fludarabine | Other | Reduced-intensity fludarabine with intermediate-dose TBI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare the time to recovery of circulating neutrophils and platelets of all patients to determine incidence of graft rejection | 30 days after transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who are still alive as assessed by survival status at certain timepoints after transplant | 36 months after transplant | |
| Number of patients with relapsed disease as assessed by labs, bone marrow biopsies and radiological scans at certain timepoints after transplant |
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Inclusion Criteria:
Exclusion Criteria:
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Male or female patients with any hematologic malignancy that requires an allogeneic transplant from a halpo-identical matched related donor
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stacey Brown | Contact | 404-480-7965 | stacey.brown@northside.com | |
| Caitlin Guzowski | Contact | 404-851-8523 | caitlin.guzowski@northside.com |
| Name | Affiliation | Role |
|---|---|---|
| Scott Solomon, MD | BMTGA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caitlin Guzowski | Recruiting | Atlanta | Georgia | 30342 | United States |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D014916 | Whole-Body Irradiation |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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| 36 months after transplant |
| Number of patients with evidence of graft versus host disease as assessed by weekly progress notes after transplant | 36 months after transplant |
| Number of participants who died in the absence of relapse or progression as assessed by survival status at certain timepoints after transplant | 1 year after transplant |
| Number of participants with responses to treatment as assessed by labs, bone marrow biopsies and radiological scans at certain timepoints after transplant | 36 months after transplant |
| Number of participants with treatment-related adverse events as assessed by CTCAE v.5.0 | 90 days after transplant |