A Phase II Study Assessing the Impact of Stem Cell Dose on Progression-Free Survival in Patients Receiving High-Dose Chemotherapy and Autologous Stem Cell Transplantation for Recurrent or Persistent Diffuse Large B-Cell Lymphoma

Full 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)

Purpose

Autologous stem cell transplantation (ASCT) is a standard therapy for diffuse large B-cell lymphoma (DLBCL) that has continued to grow or came back despite therapy. With ASCT, some of a patient's blood-forming stem cells are removed before chemotherapy is completed and then returned after treatment to help re-establish a new immune and blood-forming system. Studies suggest that using higher doses of stem cells is more effective for prolonging the time it takes for a patient's cancer to come back ("progression-free survival," or PFS).

In this study, researchers are analyzing the effect of stem cell dose on PFS in patients receiving high-dose chemotherapy and ASCT for recurrent or persistent DLBCL. Patients will be randomly assigned to receive the standard dose of CD34+ stem cells or a higher dose of these cells, and researchers will compare PFS between the two groups.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have DLBCL that came back or kept growing after chemotherapy.
  • Patients must be able to undergo high-dose chemotherapy and ASCT.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Craig Sauter at 212-639-3460.

Protocol

15-193

Phase

II

Investigator

Co-Investigators