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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
59
Following enrollment, patients will be CD34+ stem cell mobilized at the discretion of the treating attending physician with the plerixafor for a maximum of 4 apheresis days, for the achievement of ≥ 7 x106 CD34+ cells/kg.
Carmustine 300 mg/m2 day -6 Etoposide 100 mg/m2 q12hrs x 8 doses day - 5 thru day -2 Cytarabine 100 mg/m2 q12hrs x 8 doses day - 5 thru day -2 Melphalan 140 mg/m2 day -1 BEAM dosages may be adjusted per institutional dose adjustments based on body weight.
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
progression-free survival (PFS)
equals date of progression/death - date of Autologous Stem Cell Transplantation
Time frame: at +/- 2 weeks
the impact of CD34+ cell dose on lymphocyte subset recovery
(ALC15) post HDT-ASCT Accordingly, each subject will be classified as a responder (i.e., recovery) or non-responder.
Time frame: day 15
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 4 more locations