Clinical trial NCT00733824
Conditions: Lymphoma, Non-Hodgkin Hodgkin Disease
Keywords: Plerixafor Lymphoma Hematopoietic Stem Cell Mobilization Transplantation, Autologous Receptors, CXCR4
Sponsor: Washington University School of Medicine
Start date: 2008-11-01; Completion date: 2013-09-01
Enrollment: 61 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of intravenous AMD3100 added to a standard G-CSF mobilization regimen of patients undergoing autologous stem cell transplantation for lymphoma.

The investigators hypothesize that after stem cell mobilization with G-CSF plus IV AMD3100, a significantly higher proportion of lymphoma patients will collect ≥ 2 x 10E6 CD34+ cells/kg.

Detailed description:
Autologous stem cell transplantation (ASCT) is indicated for patients with non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL) who have primary progressive disease or who relapse after a chemotherapy-induced complete remission. For these patients, as for other patients undergoing autologous transplantation, the number of CD34+ cells collected is a reliable predictor of neutrophil and platelet (PLT) engraftment after transplantation.

AMD3100 (plerixafor) is a promising new mobilizing agent that has demonstrated efficacy in patients with NHL, HL, and multiple myeloma (MM). Although efficacious, the subcutaneous dosing of AMD3100 requires that patients receive the drug in the evening prior to apheresis, which can present logistical problems. Intravenous dosing of AMD3100 may result in a faster rise in peripheral CD34+ cell count, so that the drug can be administered the same day as apheresis. Intravenous dosing may also increase the peak CD34+ cell count, improving the number of CD34+ cells collected via apheresis.

This Phase I/II study will evaluate the safety and efficacy of intravenous AMD3100 added to the standard G-CSF mobilization regimen of patients undergoing autologous stem cell transplantation for Hodgkin and non-Hodgkin lymphomas.

Arms: arm 1: 240 µg/kg SC AMD3100 Day -5

10 µg/kg SC G-CSF Day -4 thru Day -1

160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1

Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached) arm 2: 240 µg/kg SC AMD3100 Day -5

10 µg/kg SC G-CSF Day -4 thru Day -1

240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1

Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached) arm 3: 240 µg/kg SC AMD3100 Day -5

10 µg/kg SC G-CSF Day -4 thru Day -1

320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1

Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached) arm 4: 240 µg/kg SC AMD3100 Day -5

10 µg/kg SC G-CSF Day -4 thru Day -1

400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1

Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached) arm 5: 240 µg/kg SC AMD3100 Day -5

10 µg/kg SC G-CSF Day -4 thru Day -1

MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1

Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
Interventions: intervention 1: AMD3100 intervention 2: G-CSF intervention 3: Apheresis
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents: