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
- Diseases
- Diffuse large B-cell lymphoma
- 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
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Consent and follow-up only) Coordinator of this site? Confirm its status | Basking Ridge | United States | Unknown status |
| Memorial Sloan Kettering Commack (Consent and follow-up only) Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| Memorial Sloan Kettering Westchester Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| Northwell Health (Data collection only) Coordinator of this site? Confirm its status | Manhasset | United States | Unknown status |
| Memorial Sloan Kettering Monmouth (Consent and follow-up only) Coordinator of this site? Confirm its status | Middletown | United States | Unknown status |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Memorial Sloan Kettering Bergen (Consent and follow-up only) Coordinator of this site? Confirm its status | Montvale | United States | Unknown status |
| Tennessee Oncology Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Columbia University Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Texas Transplant Institute Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Memorial Sloan Kettering Nassau (Consent and Follow-Up only) Coordinator of this site? Confirm its status | Uniondale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.