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ACTIVE NOT RECRUITING
NCT02570542
PHASE2

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

View on ClinicalTrials.gov

Summary

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

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

59

Start Date

2015-10

Completion Date

2026-10

Last Updated

2025-11-26

Healthy Volunteers

No

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

Locations (14)

University of Nebraska Medical Center

Omaha, Nebraska, United States

Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up Only)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Consent and Follow up Only)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Consent and Follow Up Only)

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack (Consent and Follow-up Only)

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, 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

Columbia University

New York, New York, United States

University of Rochester Medical Center

Rochester, 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