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)

NCT02570542 | Active Not Recruiting Phase 2

• 1 other identifier: 15-193
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 14

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• progression-free survival (PFS)

  equals date of progression/death - date of Autologous Stem Cell Transplantation

  at +/- 2 weeks

Secondary Outcomes (1)

• the impact of CD34+ cell dose on lymphocyte subset recovery

  day 15

Study Arms (2)

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.

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.

Procedure: leukapheresis; Drug: Plerixafor; Drug: carmustine, etoposide, cytarabine, melphalan; Procedure: Autologous Stem Cell Transplantation

Interventions

leukapheresis PROCEDURE

3-4 x 10^6 CD34+ stem cells/kg; 6-8 x10^6 CD34+ stem cells/kg

Plerixafor DRUG

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.

3-4 x 10^6 CD34+ stem cells/kg; 6-8 x10^6 CD34+ stem cells/kg

carmustine, etoposide, cytarabine, melphalan DRUG

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.

Also known as: BEAM chemotherapy

3-4 x 10^6 CD34+ stem cells/kg; 6-8 x10^6 CD34+ stem cells/kg

Autologous Stem Cell Transplantation PROCEDURE

3-4 x 10^6 CD34+ stem cells/kg; 6-8 x10^6 CD34+ stem cells/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Columbia University: collaborator
• Endeavor Health: collaborator
• University of Rochester: collaborator
• Medical College of Wisconsin: collaborator
• University of Nebraska: collaborator
• Sanofi: collaborator
• University Hospitals Seidman Cancer Center: collaborator

Study Sites (14)

University of Nebraska Medical Center

Omaha, Nebraska, 68198-7680, United States

Location

Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up Only)

Basking Ridge, New Jersey, United States

Location

Memorial Sloan Kettering Monmouth (Consent and Follow up Only)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Consent and Follow Up Only)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack (Consent and Follow-up Only)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Northwell Health (Data collection only)

Manhasset, New York, 11030, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Columbia University

New York, New York, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Memorial Sloan Kettering Nassau (Consent and Follow up Only)

Uniondale, New York, 11553, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Texas Transplant Institute

San Antonio, Texas, 78229, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Leukapheresis; plerixafor; Carmustine; Etoposide; Cytarabine; Melphalan

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cytapheresis; Biological Therapy; Therapeutics; Blood Component Removal; Leukocyte Reduction Procedures; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Sergio Giralt, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: October 7, 2015
• Study Start: October 1, 2015
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

US (14)