Stem Cell Mobilization in Treating Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma following High-Dose Therapy and Autologous Stem Cell Transplant

Status: Active

Description

This randomized phase II trial studies how well stem cell mobilization works in treating patients with diffuse large B-cell lymphoma (DLBCL) that has come back (relapsed) or does not respond to treatment (refractory) following high dose therapy and autologous stem cell transplant. An autologous transplant is infusion of the patient’s own bone marrow cells (stem cells) following a high-dose of chemotherapy. Giving lower doses of stem cells may lessen the likelihood of reactions and having additional standard stem cell dose remaining for a potential second transplant.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with relapsed or refractory de novo DLBCL or follicular lymphoma transformed to DLBCL to one previous line of anthracycline-containing chemotherapy
  • Karnofsky performance status (KPS) >= 70
  • Complete or partial response by International Working Group (IWG) Working Group or International Conference on Malignant Lymphoma (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 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
  • Last cycle of most recent salvage therapy within 8 weeks of enrollment
  • Total bilirubin =< 2.0 mg/dL * 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
  • Human immunodeficiency virus (HIV) infection
  • Comorbid condition(s) which, in the opinion of the attending physician and/or MSK Cancer Center (CC) 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

Locations & Contacts

Nebraska

Omaha
University of Nebraska Medical Center
Status: Active
Contact: Matthew Alexander Lunning
Phone: 402-559-5600

New Jersey

Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Craig S. Sauter
Phone: 212-639-3460
Email: sauterc@mskcc.org
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Craig S. Sauter
Phone: 212-639-3460
Email: sauterc@mskcc.org
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Craig S. Sauter
Phone: 212-639-3460

New York

Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Craig S. Sauter
Phone: 212-639-3460
Email: sauterc@mskcc.org
Manhasset
North Shore University Hospital
Status: Active
Contact: Ruthee-Lu Bayer
Phone: 516-734-8973
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Craig S. Sauter
Phone: 212-639-3460
Email: sauterc@mskcc.org
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: Active
Contact: Markus Y. Mapara
Phone: 212-305-5098
Rochester
University of Rochester
Status: Active
Contact: Michael William Becker
Phone: 585-275-8762
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Craig S. Sauter
Phone: 212-639-3460
Email: sauterc@mskcc.org
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Craig S. Sauter
Phone: 212-639-3460
Email: sauterc@mskcc.org

Ohio

Cleveland
Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Status: In review
Contact: Paolo Fabrizio Caimi
Phone: 216-844-3951

Tennessee

Nashville
Sarah Cannon Cancer Center
Status: Active
Contact: Carlos R. Bachier
Phone: 615-342-7440
Tennessee Oncology PLLC- Centennial Medical Center
Status: Active
Contact: Carlos R. Bachier
Phone: 615-342-7440

Texas

San Antonio
Texas Transplant Institute
Status: Active
Contact: Paul J. Shaughnessy
Phone: 210-575-8514

Wisconsin

Milwaukee
Medical College of Wisconsin
Status: Active
Contact: Nirav N. Shah
Phone: 414-955-8296

Trial Objectives and Outline

PRIMARY OBJECTIVE:

I. To determine the recovery of the absolute lymphocyte count (ALC) to > 0.5 x 10^6/mL at d+15 following autologous stem cell transplantation (ASCT).

SECONDARY OBJECTIVES:

I. To determine the impact of CD34+ cell dose on 2-year progression-free survival (PFS).

II. To determine the impact of CD34+ cell dose on neutrophil and platelet recovery rates.

III. To determine the impact of CD34+ cell dose on red cell and platelet transfusion requirements.

IV. To determine the ability to mobilize >= 6 x 10^6 CD34+/kg with combination plerixafor and granulocyte colony-stimulating factor (G-CSF) with or without chemotherapy priming.

V. To determine the impact of CD34+ cell dose on the incidence of grade 3 and 4 non-hematologic toxicity post-HDT/ASCT.

VI. To determine the impact of CD34+ cell dose on the duration of hospital stay from the time of stem cell re-infusion day (d)0.

VII. To determine the impact of CD34+ cell dose on toxicity following HDT-ASCT, incorporating assessment of symptom burden using the Memorial Sloan Kettering (MSK) modified M.D. Anderson Symptom Inventory (MDASI).

VIII. To determine the impact of CD34+ cell dose on the incidence of grade 3-4 infection at 3 months post-HDT-ASCT.

OUTLINE:

Patients with stem cell mobilization >= 6 x 10^6 are randomized to 1 of 2 treatment arms.

ARM I: Patients receive experimental dose CD34+ cell intravenously (IV) on day 0.

ARM II: Patients receive standard dose CD34+ cell IV on day 0.

After completion of the study treatment, patients are followed up at 15 days, 1, 3, 6, 9, 12, 18, and 24 months.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Craig S. Sauter

Trial IDs

Primary ID 15-193
Secondary IDs NCI-2016-00267
Clinicaltrials.gov ID NCT02570542