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)
- Conditions
- Refractory Diffuse Large B-cell Lymphoma (DLBCL)Diffuse Large B-cell Lymphoma (DLBCL)Relapsed Diffuse Large B-cell Lymphoma (DLBCL)
- Interventions
- Procedure: leukapheresisProcedure: Autologous Stem Cell Transplantation
- Registration Number
- NCT02570542
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 59
-
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3-4 x 10^6 CD34+ stem cells/kg leukapheresis 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. 3-4 x 10^6 CD34+ stem cells/kg Autologous Stem Cell Transplantation 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. 3-4 x 10^6 CD34+ stem cells/kg carmustine, etoposide, cytarabine, melphalan 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. 6-8 x10^6 CD34+ stem cells/kg leukapheresis 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. 6-8 x10^6 CD34+ stem cells/kg carmustine, etoposide, cytarabine, melphalan 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. 6-8 x10^6 CD34+ stem cells/kg Autologous Stem Cell Transplantation 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. 3-4 x 10^6 CD34+ stem cells/kg Plerixafor 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. 6-8 x10^6 CD34+ stem cells/kg Plerixafor 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.
- Primary Outcome Measures
Name Time Method progression-free survival (PFS) at +/- 2 weeks equals date of progression/death - date of Autologous Stem Cell Transplantation
- Secondary Outcome Measures
Name Time Method the impact of CD34+ cell dose on lymphocyte subset recovery day 15 (ALC15) post HDT-ASCT Accordingly, each subject will be classified as a responder (i.e., recovery) or non-responder.
Trial Locations
- Locations (14)
Memorial Sloan Kettering Commack (Consent and Follow-up Only)
🇺🇸Commack, New York, United States
Memorial Sloan Kettering Westchester
🇺🇸Harrison, New York, United States
Columbia University
🇺🇸New York, 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
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
Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up Only)
🇺🇸Basking Ridge, New Jersey, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Memorial Sloan Kettering Bergen (Consent and Follow Up Only)
🇺🇸Montvale, New Jersey, United States
Memorial Sloan Kettering Monmouth (Consent and Follow up Only)
🇺🇸Middletown, New Jersey, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States