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)
Running, not enrolling · Phase 2
Conditions studied: Diffuse Large B-cell Lymphoma (DLBCL), Relapsed Diffuse Large B-cell Lymphoma (DLBCL), Refractory Diffuse Large B-cell Lymphoma (DLBCL)
In brief
The purpose of this study is to study the impact of stem cell dose on outcome after autologous transplant.
Key facts
- Study ID
- NCT02570542
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 59
- Starts
- 2015-10-01
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2025-11-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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