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Optimal Dose for Initial Donor Lymphocyte Infusion Reported for Relapsed CML

Optimal Dose for Initial Donor Lymphocyte Infusion Reported for Relapsed CML

ROME—Best outcomes from donor lymphocyte infusion in chronic
myelogenous leukemia (CML) occur when the first dose does not exceed 0.2 ×
108 mononuclear cells/kg, Cesare Guglielmi, MD, reported in a presentation
at the 43rd Annual Meeting of the American Society of Clinical Oncology.

Dr. Guglielmi, who is in the Department of Cellular Biotechnology and
Hematology at La Sapienza University in Rome, reported data from a
retrospective study of 344 CML patients treated in 51 transplant centers
affiliated with the European Group for Blood and Marrow Transplantation (EBMT).
He said that lower starting doses decrease both morbidity and mortality,
with a beneficial effect on overall and failure-free survival.

"Donor lymphocyte infusion can produce durable remissions in
patients with CML who relapse after an allogeneic stem cell transplantation.
However, the best modality to administer the infusions is unclear. The
objective of this study was to evaluate how the outcome of CML relapse was
affected by the cell dose of the first donor lymphocyte infusion," Dr.
Guglielmi said.

Methods and Design

The initial cell dose (number of mononuclear cells × 108/kg received in
the first infusion) was available for 298 patients. This ranged from 0.002
to 24.4 × 108/kg, with a median initial dose of 1 × 108/kg. For purposes
of this analysis the investigators stratified patients into three groups
according to the initial dose they had received. Group A (n = 98) was the
low-dose group, ranging from 0.002 to 0.20 × 108/kg, with a median dose of
0.1 × 108/kg. Group B (n = 107) was the intermediate-dose group, ranging
from 0.21 to 2.0 × 108/kg, with a median dose of 1 × 108/kg. Group C (n =
95) was the high-dose group, ranging from 2.1 to 24.4 × 108/kg, with a
median dose of 3.5 × 108/kg. Dr. Guglielmi said that more than one infusion
was given to 62%, 20%, and 5% of patients in the low-, intermediate-, and
high-dose groups, respectively, and that the number, dose, and frequency of
additional infusions did not correlate with the initial dose.

Outcome Analysis

Responses were seen with single or multiple infusions, irrespective of
the initial cell dose. The outcomes analyzed were graft-vs-host disease
after donor lymphocyte infusion (acute grade 2-4 and/or chronic
graft-vs-host disease), myelosuppression (neutropenia and/or
thrombocytopenia), response (cytogenetic and/or molecular complete
remission), overall survival (OS), failure-free survival (FFS), and donor
lymphocyte infusion-related mortality.

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