Trials / Active Not Recruiting

Active Not RecruitingNCT02570542

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)

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)

Status: Active Not Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 59 (actual)

Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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

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.

Conditions

Interventions

Type	Name	Description
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

Timeline

Start date: 2015-10-01
Primary completion: 2026-10-01
Completion: 2026-10-01
First posted: 2015-10-07
Last updated: 2025-11-26

Locations

14 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02570542. Inclusion in this directory is not an endorsement.