Diffuse Large B-cell Lymphoma (DLBCL)Phase 2NCT02570542
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 Phase 2 study testing leukapheresis, Plerixafor and carmustine, etoposide, cytarabine, melphalan in people with Diffuse Large B-cell Lymphoma (DLBCL) and Relapsed Diffuse Large B-cell Lymphoma (DLBCL), run by Memorial Sloan Kettering Cancer Center at 14 sites in United States.
Trial summary
The purpose of this study is to study the impact of stem cell dose on outcome after autologous transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-cell Lymphoma (DLBCL), Relapsed Diffuse Large B-cell Lymphoma (DLBCL), Refractory Diffuse Large B-cell Lymphoma (DLBCL)
- What is being tested?
- leukapheresis, Plerixafor and carmustine, etoposide, cytarabine, melphalan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 14 sitesUnited States
- Study dates
- Oct 2015to Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up Only)
Basking Ridge, New Jersey
Memorial Sloan Kettering Commack (Consent and Follow-up Only)
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Northwell Health (Data collection only)
Manhasset, New York, 11030
Memorial Sloan Kettering Monmouth (Consent and Follow up Only)
Middletown, New Jersey, 07748
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Memorial Sloan Kettering Bergen (Consent and Follow Up Only)
Montvale, New Jersey, 07645
Tennessee Oncology
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Columbia University
New York, New York
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
University of Rochester Medical Center
Rochester, New York, 14642
Texas Transplant Institute
San Antonio, Texas, 78229
Memorial Sloan Kettering Nassau (Consent and Follow up Only)
Uniondale, New York, 11553
About this study
Official title: 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)
The purpose of this study is to study the impact of stem cell dose on outcome after autologous transplant.
Read the detailed description
Following enrollment, patients will be CD34+ stem cell mobilized at the discretion of the treating attending physician with the plerixafor for the achievement of >6 x10^6 CD34+ cells/kg. The patients that fail to mobilize >6 x10^6 CD34+ cells/kg will not be randomized and will subsequently be followed for disease progression and overall survival.. Patients with >6 x10^6 CD34+ cells/kg cryopreserved on study will be admitted to the hospital for planned ASCT. Patients will be randomly infused with either 3-4 x 10^6 CD34+ stem cells/kg or 6-8 x10^6 CD34+ stem cells/kg on d0 per study randomization. The cell dose ranges within the two groups allows variability within aliquots of cells at the time of cryopreservation. 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.
- Conditions
- Diffuse Large B-cell Lymphoma (DLBCL), Relapsed Diffuse Large B-cell Lymphoma (DLBCL), Refractory Diffuse Large B-cell Lymphoma (DLBCL)
- Being tested
- leukapheresis, Plerixafor, carmustine, etoposide, cytarabine, melphalan, Autologous Stem Cell Transplantation
- Keywords
- CD34+ Cell Dose, Autologous Stem Cell Transplantation, 15-193
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leukapheresisProcedure or surgery
PlerixaforDrug
Following enrollment, patients will be CD34+ stem cell mobilized at the discretion of the treating attending physician with the plerixafor for a maximum of 4 apheresis days, for the achievement of ≥ 7 x106 CD34+ cells/kg.
carmustine, etoposide, cytarabine, melphalanDrug
Also called BEAM chemotherapy
Carmustine 300 mg/m2 day -6 Etoposide 100 mg/m2 q12hrs x 8 doses day - 5 thru day -2 Cytarabine 100 mg/m2 q12hrs x 8 doses day - 5 thru day -2 Melphalan 140 mg/m2 day -1 BEAM dosages may be adjusted per institutional dose adjustments based on body weight.
Autologous Stem Cell TransplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 3-4 x 10^6 CD34+ stem cells/kg | Active comparator | 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. Receives: Procedure: leukapheresis; Drug: Plerixafor; Drug: carmustine, etoposide, cytarabine, melphalan; Procedure: Autologous Stem Cell Transplantation |
| 6-8 x10^6 CD34+ stem cells/kg | Experimental | 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. Receives: Procedure: leukapheresis; Drug: Plerixafor; Drug: carmustine, etoposide, cytarabine, melphalan; Procedure: Autologous Stem Cell Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival (PFS)
equals date of progression/death - date of Autologous Stem Cell Transplantation
Measured: at +/- 2 weeks
Secondary outcomes (1)
the impact of CD34+ cell dose on lymphocyte subset recovery
(ALC15) post HDT-ASCT Accordingly, each subject will be classified as a responder (i.e., recovery) or non-responder.
Measured: day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-cell Lymphoma (DLBCL)Studies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, Endeavor Health, University of Rochester, Medical College of Wisconsin, University of Nebraska, Sanofi, University Hospitals Seidman Cancer Center
- Responsible party
- Sponsor
- Investigators
- Sergio Giralt, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570542
- Sponsor's protocol ID
- 15-193
- Status last verified
- Nov 2026
- First submitted
- 5 Oct 2015
- Last updated
- 4 Nov 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02570542
- Acronym / sponsor ID
- 15-193
- Conditions
- Diffuse Large B-cell Lymphoma (DLBCL), Relapsed Diffuse Large B-cell Lymphoma (DLBCL), Refractory Diffuse Large B-cell Lymphoma (DLBCL)
- Keywords
- CD34+ Cell Dose, Autologous Stem Cell Transplantation, 15-193
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Columbia University, Endeavor Health, University of Rochester, Medical College of Wisconsin, University of Nebraska, Sanofi, University Hospitals Seidman Cancer Center
- Study start
- Oct 2015 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to study the impact of stem cell dose on outcome after autologous transplant.
Detailed description
Following enrollment, patients will be CD34+ stem cell mobilized at the discretion of the treating attending physician with the plerixafor for the achievement of >6 x10^6 CD34+ cells/kg. The patients that fail to mobilize >6 x10^6 CD34+ cells/kg will not be randomized and will subsequently be followed for disease progression and overall survival.. Patients with >6 x10^6 CD34+ cells/kg cryopreserved on study will be admitted to the hospital for planned ASCT. Patients will be randomly infused with either 3-4 x 10^6 CD34+ stem cells/kg or 6-8 x10^6 CD34+ stem cells/kg on d0 per study randomization. The cell dose ranges within the two groups allows variability within aliquots of cells at the time of cryopreservation. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3-4 x 10^6 CD34+ stem cells/kg | Active comparator | Procedure: leukapheresis, Drug: Plerixafor, Drug: carmustine, etoposide, cytarabine, melphalan, Procedure: Autologous Stem Cell TransplantationPatients 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. |
| 6-8 x10^6 CD34+ stem cells/kg | Experimental | Procedure: leukapheresis, Drug: Plerixafor, Drug: carmustine, etoposide, cytarabine, melphalan, Procedure: Autologous Stem Cell TransplantationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| leukapheresis | Procedure or surgery | 3-4 x 10^6 CD34+ stem cells/kg, 6-8 x10^6 CD34+ stem cells/kg |
| PlerixaforFollowing enrollment, patients will be CD34+ stem cell mobilized at the discretion of the treating attending physician with the plerixafor for a maximum of 4 apheresis days, for the achievement of ≥ 7 x106 CD34+ cells/kg. | Drug | 3-4 x 10^6 CD34+ stem cells/kg, 6-8 x10^6 CD34+ stem cells/kg |
| carmustine, etoposide, cytarabine, melphalanAlso: BEAM chemotherapyCarmustine 300 mg/m2 day -6 Etoposide 100 mg/m2 q12hrs x 8 doses day - 5 thru day -2 Cytarabine 100 mg/m2 q12hrs x 8 doses day - 5 thru day -2 Melphalan 140 mg/m2 day -1 BEAM dosages may be adjusted per institutional dose adjustments based on body weight. | Drug | 3-4 x 10^6 CD34+ stem cells/kg, 6-8 x10^6 CD34+ stem cells/kg |
| Autologous Stem Cell Transplantation | Procedure or surgery | 3-4 x 10^6 CD34+ stem cells/kg, 6-8 x10^6 CD34+ stem cells/kg |
Primary outcome
progression-free survival (PFS)
Time frame: at +/- 2 weeks
equals date of progression/death - date of Autologous Stem Cell Transplantation
1 secondary outcome
the impact of CD34+ cell dose on lymphocyte subset recovery
Time frame: day 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio Giralt, MD principal investigator
Memorial Sloan Kettering Cancer Center
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing leukapheresis, Plerixafor and carmustine, etoposide, cytarabine, melphalan in people with Diffuse Large B-cell Lymphoma (DLBCL) and Relapsed Diffuse Large B-cell Lymphoma (DLBCL), run by Memorial Sloan Kettering Cancer Center at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (PFS) (time frame: at +/- 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.