Impact of CD34+ Cell Dose on Progression-free Survival Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL)

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.

Inclusion Criteria:

- Age ≥ 18 years old

- Diagnosed with relapsed or refractory de novo DLBCL or follicular lymphoma transformed
to DLBCL to one previous line of anthracycline-containing chemotherapy

- KPS ≥ 70

- Complete or partial response by IWG Working Group or ICML Criteria to maximum of one
salvage line of chemotherapy without pre-HDT/ASCT salvage radiotherapy.

- Eligible for high-dose therapy and autologous stem-cell rescue

- Serum creatinine ≤ 1.5 mg/dL, or if creatinine >1.5 mg/dL, calculated creatinine
clearance of ≥50 mL/min by 24 hour creatinine clearance or CKD-EPI.

- Last cycle of most recent salvage therapy within 8 weeks of enrollment

- Total bilirubin < 2.0 mg/dL

o If Gilbert‟s disease is suspected and total bilirubin > 2.0 mg/dL, direct bilirubin
must be < 2.0 mg/dL

- Females of childbearing potential and males must agree to use an acceptable form of
contraception per institutional practices.

Exclusion Criteria:

- Disease progression by IWG Working Group or ICML Criteria since last therapy

- Prior autologous or allogeneic stem cell transplantation

- HIV infection

- Comorbid condition(s) which, in the opinion of the attending physician and/or MSKCC
Principal Investigator, will preclude stem cell mobilization and/or high-dose therapy
with autologous stem cell rescue

- Treatment plan that includes post-transplant maintenance therapy

- Salvage therapy that includes involved field radiotherapy