Anemia Clinical Trial
Official title:
Compassionate Use of the CliniMACS® CD34 Reagent System for Patients Requiring a Post Hematopoietic Stem Cell Transplant Boost of Donor Hematopoietic Stem Cells
Verified date | October 2016 |
Source | Thomas Jefferson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This clinical trial studies how well donor stem cell boost works in treating patients with low blood cells after donor stem cell transplant. Donor stem cell boost may increase low blood cell counts caused by hematologic cancer or its treatment.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. No evidence of active disease as measured by staging studies pertinent to the particular diagnosis within 1 month of the CD 34+ boost 2. Full donor chimerism as manifested by a = 90% donor peripheral blood total, MNC, and T cell chimerism result on the last two studies prior to the planned CD 34+ boost, with the second study performed within 1 month of the infusion. 3. HHV-6 and CMV negative by PCR for at least 1 month prior to the CD 34+ boost as measured by at least 2 assays within the month timeframe 4. ANC of < 1000 10^6/L or maintenance of an ANC = 1000 10^6/L only with white cell growth factor support 5. Requirement for red cell transfusion to maintain a hemoglobin of = 9.0 g/dL 6. Requirement for red cell transfusion to avoid symptomatic anemia in patients with hemoglobin values of = 11.0 g/dL 7. Requirement for platelet transfusion to maintain a platelet count of = 20 10^9/L 8. Requirement for platelet transfusion to avoid bleeding in patients with platelet counts = 50 109/L 9. No signs of active acute GVHD (excluding stages I-II skin GVHD) |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Cancer Center at Thomas Jefferson University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Etiologies of post HSCT cytopenias | Will be collected and reported descriptively. | Up to 8 weeks | No |
Primary | CD34+/kg and CD3+/kg cell doses in the infused CD 34+ selected boost products | Will be collected and reported descriptively. | Up to 8 weeks | No |
Primary | Effects of the CD 34+ selected boost on peripheral blood cell counts | Will be collected and reported descriptively. | Up to 8 weeks | No |
Primary | Incidence of GVHD related to the CD34+ selected boost | Will be collected and reported descriptively. | Up to 8 weeks | No |
Primary | Incidence of grade 3-5 infusion reactions, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 | Will be descriptive. | Up to 8 weeks | Yes |
Primary | Incidence of severe GVHD (grades 3-4), graded according to standard criteria | Will be descriptive. | Up to 8 weeks | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
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