Spots Global Cancer Trial Database for Study of the Impact of CD34+ Cell Dose on Absolute Lymphocyte Count Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL)
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Trial Identification
Brief Title: Study of the Impact of CD34+ Cell Dose on Absolute Lymphocyte Count Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Official Title: A Multi-center Randomized Phase II Study of the Impact of CD34+ Cell Dose on Absolute Lymphocyte Count Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Study ID: NCT02570542
Study Description
Brief Summary: The purpose of this study is to study the impact of stem cell dose on outcome after autologous transplant.
Detailed Description: Following enrollment, patients will be CD34+ stem cell mobilized at the discretion of the treating attending physician with the plerixafor for the achievement of \>6 x10\^6 CD34+ cells/kg. The patients that fail to mobilize \>6 x10\^6 CD34+ cells/kg will not be randomized and will subsequently be followed for disease progression and overall survival.. Patients with \>6 x10\^6 CD34+ cells/kg cryopreserved on study will be admitted to the hospital for planned ASCT. Patients will be randomly infused with either 3-4 x 10\^6 CD34+ stem cells/kg or 6-8 x10\^6 CD34+ stem cells/kg on d0 per study randomization. The cell dose ranges within the two groups allows variability within aliquots of cells at the time of cryopreservation. Patients will receive standard supportive measures (including: growth factor support post-HDT/ASCT, antimicrobial prophylaxis, red blood cell and platelet transfusion and treatment for neutropenic fever) as per institutional guideline practices.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Nebraska Medical Center, Omaha, Nebraska, United States
Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up Only), Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Consent and Follow up Only), Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Consent and Follow Up Only), Montvale, New Jersey, United States
Memorial Sloan Kettering Commack (Consent and Follow-up Only), Commack, New York, United States
Memorial Sloan Kettering Westchester, Harrison, New York, United States
Northwell Health (Data collection only), Manhasset, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Columbia University, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
Memorial Sloan Kettering Nassau (Consent and Follow up Only), Uniondale, New York, United States
Tennessee Oncology, Nashville, Tennessee, United States
Texas Transplant Institute, San Antonio, Texas, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Sergio Giralt, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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