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Impact of CD34+ Cell Dose on Progression-free Survival Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL)

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ClinicalTrials.gov Identifier: NCT02570542
Recruitment Status : Recruiting
First Posted : October 7, 2015
Last Update Posted : November 27, 2018
Sponsor:
Collaborators:
Columbia University
NorthShore University HealthSystem
University of Rochester
Medical College of Wisconsin
University of Nebraska
Sanofi
University Hospitals Seidman Cancer Center
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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

Condition or disease Intervention/treatment Phase
Diffuse Large B-cell Lymphoma (DLBCL) Relapsed Diffuse Large B-cell Lymphoma (DLBCL) Refractory Diffuse Large B-cell Lymphoma (DLBCL) Procedure: leukapheresis Drug: Plerixafor Drug: carmustine, etoposide, cytarabine, melphalan Procedure: Autologous Stem Cell Transplantation Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center Randomized Phase II Study of the Impact of CD34+ Cell Dose on Progression-free Survival Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Actual Study Start Date : October 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Active Comparator: 3-4 x 10^6 CD34+ stem cells/kg
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
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.

Drug: 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.
Other Name: BEAM chemotherapy

Procedure: Autologous Stem Cell Transplantation
Experimental: 6-8 x10^6 CD34+ stem cells/kg
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
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.

Drug: 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.
Other Name: BEAM chemotherapy

Procedure: Autologous Stem Cell Transplantation



Primary Outcome Measures :
  1. progression-free survival (PFS) [ Time Frame: at +/- 2 weeks ]
    equals date of progression/death - date of Autologous Stem Cell Transplantation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02570542


Contacts
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Contact: Craig Sauter, MD 212-639-3460
Contact: Sergio Giralt, MD 212-639-6009

Locations
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United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-7680
Contact: Matthew Lunning, D.O.         
Principal Investigator: Matthew Lunning, D.O.         
United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States
Contact: Craig Sauter, MD    212-639-3460      
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Craig Sauter, MD    212-639-3460      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Craig Sauter, MD    212-639-3460      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Craig Sauter, MD    212-639-3460      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Craig Sauter, MD    212-639-3460      
Northwell Health Recruiting
Manhasset, New York, United States, 11030
Contact: Ruthee-lu Bayer, MD    516-734-8973      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Craig Sauter, MD    212-639-3460      
Contact: Sergio Giralt, MD    212-639-6009      
Principal Investigator: Craig Sauter, MD         
Columbia University Recruiting
New York, New York, United States
Contact: Markus Mapara, MD    212-305-5098      
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Michael Becker, MD    585-275-5823      
Principal Investigator: Michael Becker, MD         
Memorial Sloan Kettering Rockville Centre Recruiting
Rockville Centre, New York, United States
Contact: Craig Sauter, MD    212-639-3460      
United States, Ohio
University Hospitals Seidman Cancer Center Not yet recruiting
Cleveland, Ohio, United States
Contact: Paolo Caimi, MD    216-844-3951      
United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Contact: Carlos Bachier, MD    615-342-7440      
United States, Texas
Texas Transplant Institute Recruiting
San Antonio, Texas, United States, 78229
Contact: Paul Shaughnessy, MD    210-575-3817      
Principal Investigator: Paul Shaughnessy, MD         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Nirav Shah, MD    414-955-8296      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Columbia University
NorthShore University HealthSystem
University of Rochester
Medical College of Wisconsin
University of Nebraska
Sanofi
University Hospitals Seidman Cancer Center
Investigators
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Principal Investigator: Craig Sauter, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02570542     History of Changes
Other Study ID Numbers: 15-193
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018

Keywords provided by Memorial Sloan Kettering Cancer Center:
CD34+ Cell Dose
Autologous Stem Cell Transplantation
15-193

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Etoposide
Etoposide phosphate
Cytarabine
Melphalan
Carmustine
Plerixafor octahydrochloride
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating