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NCT02570542Active, not recruitingPhase 2

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)

Source: ClinicalTrials.gov · Last updated 30 Oct 2026

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
59 (actual)
First submitted
5 Oct 2015
Start date
1 Oct 2015
Primary completion date
31 Oct 2026
Lead sponsor
Memorial Sloan Kettering Cancer Center
NCT number
NCT02570542

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 59
  • From 1 Oct 2015 to the primary completion date, 31 Oct 2026
  • 14 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior autologous or allogeneic stem cell transplantation
  • Treatment plan that includes post-transplant maintenance therapy
  • Salvage therapy that includes involved field radiotherapy

Other illness

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

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)
Coordinator of this site? Confirm its status
Basking RidgeUnited StatesUnknown status
Memorial Sloan Kettering Commack (Consent and follow-up only)
Coordinator of this site? Confirm its status
CommackUnited StatesUnknown status
Memorial Sloan Kettering Westchester
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HarrisonUnited StatesUnknown status
Northwell Health (Data collection only)
Coordinator of this site? Confirm its status
ManhassetUnited StatesUnknown status
Memorial Sloan Kettering Monmouth (Consent and follow-up only)
Coordinator of this site? Confirm its status
MiddletownUnited StatesUnknown status
Medical College of Wisconsin
Coordinator of this site? Confirm its status
MilwaukeeUnited StatesUnknown status
Memorial Sloan Kettering Bergen (Consent and follow-up only)
Coordinator of this site? Confirm its status
MontvaleUnited StatesUnknown status
Tennessee Oncology
Coordinator of this site? Confirm its status
NashvilleUnited StatesUnknown status
Columbia University
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
University of Nebraska Medical Center
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OmahaUnited StatesUnknown status
University of Rochester Medical Center
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
Texas Transplant Institute
Coordinator of this site? Confirm its status
San AntonioUnited StatesUnknown status
Memorial Sloan Kettering Nassau (Consent and Follow-Up only)
Coordinator of this site? Confirm its status
UniondaleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.