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)

November 24, 2025 updated by: Memorial Sloan Kettering Cancer Center

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)

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198-7680
        • University of Nebraska Medical Center
    • New Jersey
      • Basking Ridge, New Jersey, United States
        • Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Monmouth (Consent and Follow up Only)
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering Bergen (Consent and Follow Up Only)
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Commack (Consent and follow-up only)
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester
      • Manhasset, New York, United States, 11030
        • Northwell Health (Data collection only)
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States
        • Columbia University
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Nassau (Consent and Follow up Only)
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology
    • Texas
      • San Antonio, Texas, United States, 78229
        • Texas Transplant Institute
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: leukapheresis
Drug: Plerixafor
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.
Drug: carmustine, etoposide, cytarabine, melphalan
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.
Other Names:
  • BEAM chemotherapy
Procedure: Autologous Stem Cell Transplantation
Experimental: 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.
Procedure: leukapheresis
Drug: Plerixafor
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.
Drug: carmustine, etoposide, cytarabine, melphalan
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.
Other Names:
  • BEAM chemotherapy
Procedure: Autologous Stem Cell Transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival (PFS)
Time Frame: at +/- 2 weeks
equals date of progression/death - date of Autologous Stem Cell Transplantation
at +/- 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the impact of CD34+ cell dose on lymphocyte subset recovery
Time Frame: day 15
(ALC15) post HDT-ASCT Accordingly, each subject will be classified as a responder (i.e., recovery) or non-responder.
day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Sanofi
Columbia University
Medical College of Wisconsin
University of Rochester
University of Nebraska
University Hospitals Seidman Cancer Center
Endeavor Health

Investigators

  • Principal Investigator: Sergio Giralt, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

October 5, 2015

First Submitted That Met QC Criteria

October 5, 2015

First Posted (Estimated)

October 7, 2015

Study Record Updates

Last Update Posted (Estimated)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-193

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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