Stem Cell Mobilization in Treating Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma following High-Dose Therapy and Autologous Stem Cell Transplant
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
Nebraska
Omaha
New Jersey
Basking Ridge
Middletown
Montvale
New York
Commack
Manhasset
New York
Rochester
Uniondale
West Harrison
Ohio
Cleveland
Tennessee
Nashville
Texas
San Antonio
Wisconsin
Milwaukee
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 Phase II
Trial Type Treatment
Lead Organization
Memorial Sloan Kettering Cancer Center
Principal Investigator
Craig S. Sauter
- Primary ID 15-193
- Secondary IDs NCI-2016-00267
- Clinicaltrials.gov ID NCT02570542