Back to resultsStudy 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)
Primary Purpose
Diffuse Large B-cell Lymphoma (DLBCL), Relapsed Diffuse Large B-cell Lymphoma (DLBCL), Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
leukapheresis
Plerixafor
carmustine, etoposide, cytarabine, melphalan
Autologous Stem Cell Transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Diffuse Large B-cell Lymphoma (DLBCL) focused on measuring CD34+ Cell Dose, Autologous Stem Cell Transplantation, 15-193
Eligibility 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
Sites / Locations
- University of Nebraska Medical Center
- Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up Only)
- Memorial Sloan Kettering Monmouth (Consent and Follow up Only)
- Memorial Sloan Kettering Bergen (Consent and Follow Up Only)
- Memorial Sloan Kettering Commack (Consent and Follow-up Only)
- Memorial Sloan Kettering Westchester
- Northwell Health (Data collection only)
- Memorial Sloan Kettering Cancer Center
- Columbia University
- University of Rochester Medical Center
- Memorial Sloan Kettering Nassau (Consent and Follow up Only)
- Tennessee Oncology
- Texas Transplant Institute
- Medical College of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
3-4 x 10^6 CD34+ stem cells/kg
6-8 x10^6 CD34+ stem cells/kg
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
progression-free survival (PFS)
equals date of progression/death - date of Autologous Stem Cell Transplantation
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02570542
First Posted
October 5, 2015
Last Updated
July 6, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Columbia University, NorthShore University HealthSystem, University of Rochester, Medical College of Wisconsin, University of Nebraska, Sanofi, University Hospitals Seidman Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT02570542
Brief Title
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)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2015 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Columbia University, NorthShore University HealthSystem, University of Rochester, Medical College of Wisconsin, University of Nebraska, Sanofi, University Hospitals Seidman Cancer Center
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3-4 x 10^6 CD34+ stem cells/kg
Arm Type
Active Comparator
Arm Description
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.
Arm Title
6-8 x10^6 CD34+ stem cells/kg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
leukapheresis
Intervention Type
Drug
Intervention Name(s)
Plerixafor
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
carmustine, etoposide, cytarabine, melphalan
Other Intervention Name(s)
BEAM chemotherapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Autologous Stem Cell Transplantation
Primary Outcome Measure Information:
Title
progression-free survival (PFS)
Description
equals date of progression/death - date of Autologous Stem Cell Transplantation
Time Frame
at +/- 2 weeks
Secondary Outcome Measure Information:
Title
the impact of CD34+ cell dose on lymphocyte subset recovery
Description
(ALC15) post HDT-ASCT Accordingly, each subject will be classified as a responder (i.e., recovery) or non-responder.
Time Frame
day 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio Giralt, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States
Facility Name
Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up Only)
City
Basking Ridge
State/Province
New Jersey
Country
United States
Facility Name
Memorial Sloan Kettering Monmouth (Consent and Follow up Only)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Bergen (Consent and Follow Up Only)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Memorial Sloan Kettering Commack (Consent and Follow-up Only)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Northwell Health (Data collection only)
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Memorial Sloan Kettering Nassau (Consent and Follow up Only)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Transplant Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
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)
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