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)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

October 31, 2015

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2025

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

Trial Locations (14)

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Westchester, Harrison

11030

Northwell Health (Data collection only), Manhasset

11553

Memorial Sloan Kettering Nassau (Consent and Follow up Only), Uniondale

11725

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

14642

University of Rochester Medical Center, Rochester

37203

Tennessee Oncology, Nashville

53226

Medical College of Wisconsin, Milwaukee

78229

Texas Transplant Institute, San Antonio

68198-7680

University of Nebraska Medical Center, Omaha

Unknown

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

Columbia University, New York

07748

Memorial Sloan Kettering Monmouth (Consent and Follow up Only), Middletown

07645

Memorial Sloan Kettering Bergen (Consent and Follow Up Only), Montvale

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Columbia University

OTHER

collaborator

Endeavor Health

OTHER

collaborator

University of Rochester

OTHER

collaborator

Medical College of Wisconsin

OTHER

collaborator

University of Nebraska

OTHER

collaborator

Sanofi

INDUSTRY

collaborator

University Hospitals Seidman Cancer Center

OTHER

lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT02570542 - 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) | Biotech Hunter | Biotech Hunter