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: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Columbia University; Medical College of Wisconsin; Montefiore Medical Center; NorthShore University HealthSystem; Sanofi; SCRI Development Innovations, LLC; The Cleveland Clinic; University Hospitals Seidman Cancer Center; University of Nebraska; University of Rochester; Weill Medical College of Cornell University
• Treatments: Carmustine; Cytarabine; Etoposide; Etoposide phosphate; JM 3100; Melphalan; Plerixafor

Criteria

Inclusion Criteria:

• 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 Gilbert"s 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.

Exclusion Criteria:

• Disease progression by IWG Working Group or ICML Criteria since last therapy

• Prior autologous or allogeneic stem cell transplantation

• HIV infection

• Comorbid condition(s) which, in the opinion of the attending physician and/or MSKCC Principal Investigator, will preclude stem cell mobilization and/or high-dose therapy with autologous stem cell rescue

• Treatment plan that includes post-transplant maintenance therapy

• Salvage therapy that includes involved field radiotherapy