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)

Who is this study for? Adult patients with diffuse large B-cell lymphoma
Status: Active_not_recruiting
Location: See all (14) locations...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 Gilberts 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.

Locations
United States
Nebraska
University of Nebraska Medical Center
Omaha
New Jersey
Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up Only)
Basking Ridge
Memorial Sloan Kettering Monmouth (Consent and Follow up Only)
Middletown
Memorial Sloan Kettering Bergen (Consent and Follow Up Only)
Montvale
New York
Memorial Sloan Kettering Commack (Consent and Follow-up Only)
Commack
Memorial Sloan Kettering Westchester
Harrison
Northwell Health (Data collection only)
Manhasset
Columbia University
New York
Memorial Sloan Kettering Cancer Center
New York
University of Rochester Medical Center
Rochester
Memorial Sloan Kettering Nassau (Consent and Follow up Only)
Uniondale
Tennessee
Tennessee Oncology
Nashville
Texas
Texas Transplant Institute
San Antonio
Wisconsin
Medical College of Wisconsin
Milwaukee
Time Frame
Start Date: 2015-10
Completion Date: 2025-10
Participants
Target number of participants: 59
Treatments
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.
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.
Sponsors
Collaborators: University of Nebraska, Endeavor Health, University Hospitals Seidman Cancer Center, Columbia University, University of Rochester, Medical College of Wisconsin, Sanofi
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov