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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02570542.
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.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorSergio Andres Giralt
