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)
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Enrollment
- 59
- Locations
- 14
- Primary Endpoint
- progression-free survival (PFS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
3-4 x 10^6 CD34+ stem cells/kg
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.
Intervention: leukapheresis (Procedure)
3-4 x 10^6 CD34+ stem cells/kg
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.
Intervention: Plerixafor (Drug)
3-4 x 10^6 CD34+ stem cells/kg
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.
Intervention: carmustine, etoposide, cytarabine, melphalan (Drug)
3-4 x 10^6 CD34+ stem cells/kg
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.
Intervention: Autologous Stem Cell Transplantation (Procedure)
6-8 x10^6 CD34+ stem cells/kg
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.
Intervention: leukapheresis (Procedure)
6-8 x10^6 CD34+ stem cells/kg
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.
Intervention: Plerixafor (Drug)
6-8 x10^6 CD34+ stem cells/kg
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.
Intervention: carmustine, etoposide, cytarabine, melphalan (Drug)
6-8 x10^6 CD34+ stem cells/kg
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.
Intervention: Autologous Stem Cell Transplantation (Procedure)
Outcomes
Primary Outcomes
progression-free survival (PFS)
Time Frame: at +/- 2 weeks
equals date of progression/death - date of Autologous Stem Cell Transplantation
Secondary Outcomes
- the impact of CD34+ cell dose on lymphocyte subset recovery(day 15)