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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)

NCT02570542 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2025-11-26

No results posted yet for this study

Summary

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

Conditions

  • Diffuse Large B-cell Lymphoma (DLBCL)
  • Relapsed Diffuse Large B-cell Lymphoma (DLBCL)
  • Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Interventions

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.

PROCEDURE

Autologous Stem Cell Transplantation

Sponsors & Collaborators

  • Columbia University

    collaborator OTHER

  • Endeavor Health

    collaborator OTHER

  • University of Rochester

    collaborator OTHER

  • Medical College of Wisconsin

    collaborator OTHER

  • University of Nebraska

    collaborator OTHER

  • Sanofi

    collaborator INDUSTRY

  • University Hospitals Seidman Cancer Center

    collaborator OTHER

  • Memorial Sloan Kettering Cancer Center

    lead OTHER

Principal Investigators

  • Sergio Giralt, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02570542 on ClinicalTrials.gov