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)

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT02570542

This study examines the effect of CD34+ stem cell dose on outcomes post-autologous transplant in DLBCL patients. Eligible participants, aged ≥18, with specific health criteria, will undergo leukapheresis and plerixafor mobilization. Randomized groups receive varying stem cell doses, followed by BEAM chemotherapy and ASCT, with standard supportive care provided.

Patient Parameters

Program Overview

The purpose of this study is to study the impact of stem cell dose on outcome after autologous transplant.

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.

Eligibility Criteria

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

Locations

FACILITYZIPCITYSTATE
University of Nebraska Medical Center68198-7680OmahaNebraska
Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up Only)Basking RidgeNew Jersey
Memorial Sloan Kettering Monmouth (Consent and Follow up Only)07748MiddletownNew Jersey
Memorial Sloan Kettering Bergen (Consent and Follow Up Only)07645MontvaleNew Jersey
Memorial Sloan Kettering Commack (Consent and Follow-up Only)11725CommackNew York
Memorial Sloan Kettering Westchester10604HarrisonNew York
Northwell Health (Data collection only)11030ManhassetNew York
Memorial Sloan Kettering Cancer Center10065New YorkNew York
Columbia UniversityNew YorkNew York
University of Rochester Medical Center14642RochesterNew York

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