Lymphoma Clinical Trial
Official title:
CD34+Stem Cell Selection for Patients Receiving Partially Matched Family or Matched Unrelated Adult Donor Allogeneic Stem Cell Transplantations for Malignant and Non-Malignant Disease
Verified date | August 2018 |
Source | New York Medical College |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
CD34+ stem cell selection in children, adolescents and young adults receiving partially matched family donor or matched unrelated adult donor allogeneic bone marrow or peripheral blood stem cell transplant will be safe and well tolerated and be associated with a low incidence of serious (Grade III/IV) acute and chronic graft versus host disease (GVHD).
Status | Completed |
Enrollment | 20 |
Est. completion date | August 2018 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 70 Years |
Eligibility |
Inclusion Criteria: - Adequate renal function defined as:Serum creatinine <1.5 x normal, or Creatinine clearance or radioisotope GFR >60 ml/min/m2 or an equivalent GFR as determined by the institutional normal range. - Adequate liver function defined as:Total bilirubin <1.5 x normal, or SGOT (AST) or SGPT (ALT) <3.0 x normal - Adequate cardiac function defined as:Shortening fraction >27% by echocardiogram, or Ejection fraction of >47% by radionucleotide angiogram or echocardiogram. - Adequate pulmonary function defined as:Uncorrected DLCO >50% by pulmonary function test. For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry >94% on room air. Eligibility for Reduced Intensity Regimen: - Adequate renal function defined as:Serum creatinine 2.0 x normal, or creatinine clearance or radioisotope GFR > 40 ml/min/m2 or an equivalent GFR as determined by the institutional normal range. - Adequate liver function defined as:Total bilirubin < 2.5 x normal; or SGOT (AST) or SGPT (ALT) < 5.0 x normal. - Adequate cardiac function defined as:Shortening fraction of >25% by echocardiogram, or Ejection fraction of >40% by radionuclide angiogram or echocardiogram. - Adequate pulmonary function defined as:DLCO >35% by pulmonary function test. For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry >94% in room air. Exclusion Criteria: - Pregnancy/Breast Feeding: Females who are pregnant or breast-feeding are not eligible. - Infection: Patients with documented uncontrolled infection at the time of study entry are not eligible. |
Country | Name | City | State |
---|---|---|---|
United States | New York Medical College | Valhalla | New York |
Lead Sponsor | Collaborator |
---|---|
New York Medical College |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The safety CD34+ stem cell selection | serious adverse events will be monitored post transplant to determine if there is an increase vs. historical data related to the CD34+ selection | 100 days | |
Secondary | Immune reconstitution (T, B, DC) following CD34+ selection | immune subsets will be drawn post transplant to determine the rate of reconstitution post CD34+ transplant to determine if this process increases or decreases the reconstitution time. | 3 years |
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