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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)
The purpose of this study is to study the impact of stem cell dose on outcome after autologous transplant.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
October 1, 2015
Primary Completion Date
October 1, 2026
Completion Date
October 1, 2026
Last Updated
November 26, 2025
59
ACTUAL participants
leukapheresis
PROCEDURE
Plerixafor
DRUG
carmustine, etoposide, cytarabine, melphalan
DRUG
Autologous Stem Cell Transplantation
PROCEDURE
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
NCT06043011
NCT04488354
Data Source & Attribution
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