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)

Diffuse Large B-cell Lymphoma (DLBCL) Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02570542
• Other study ID #: 15-193
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 2015
• Est. completion date: October 2024

Study information

• Verified date: July 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 59
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma (DLBCL)
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Refractory Diffuse Large B-cell Lymphoma (DLBCL)
• Relapsed Diffuse Large B-cell Lymphoma (DLBCL)

Intervention

Procedure:
• leukapheresis

Drug:
• Plerixafor
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, melphalan
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.

Procedure:
• Autologous Stem Cell Transplantation

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up Only)	Basking Ridge	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 Monmouth (Consent and Follow up Only)	Middletown	New Jersey
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Memorial Sloan Kettering Bergen (Consent and Follow Up Only)	Montvale	New Jersey
United States	Tennessee Oncology	Nashville	Tennessee
United States	Columbia University	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	University of Rochester Medical Center	Rochester	New York
United States	Texas Transplant Institute	San Antonio	Texas
United States	Memorial Sloan Kettering Nassau (Consent and Follow up Only)	Uniondale	New York

Sponsors (8)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Columbia University, Medical College of Wisconsin, NorthShore University HealthSystem, Sanofi, University Hospitals Seidman Cancer Center, University of Nebraska, University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival (PFS)	equals date of progression/death - date of Autologous Stem Cell Transplantation	at +/- 2 weeks
Secondary	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.	day 15

External Links

•   Memorial Sloan Kettering Cancer Center