autologous blood and marrow transplantation - Blog Science ...

Table 1. Patient characteristics at entry
Sex
Male
Female 40%
Age (years)
Schauten et al.
Time from diagnosis to entry
WHO0
LDH elevated
Marrow aspirate >20% B-lymphocytes
Marrow trephine positive
B symptoms
60%
48
26 months
70.8%
66%
57.1%
60.9%
Patients randomized to the chemotherapy arm were treated with three more
cycles of the same chemotherapy. Patients in the stem cell transplantation arms
were treated with high-dose cyclophosphamide (2X 60 mg/kg) followed by TBI
and stem cell transplantation.
The trial aimed for 100 patients in every randomization arm. However, because
of poor accrual the trial was closed for entry in April 1997.
A total of 140 patients were entered in the study of whom 89 fulfilled the criteria
for randomization. The baseline characteristics are shown in Table 1. Twenty-four
patients were randomized to the chemotherapy arm, 33 were transplanted with
unpurged stem cells, and 32 with purged autologous stem cells.
With a median follow-up of 30 months after randomization and complete data on
72% of the patients, we did an interim analysis. The results are shown in Table 2.
This is the only randomized trial currently ongoing in patients with relapsed
follicular non-Hodgkin's lymphoma assessing the value of high-dose therapy and
Table 2. Outcome
Chemotherapy
Purged transplant
Unpurged transplant
Not randomized
RESULTS
DISCUSSION
Progression! death
50%
78%
81%
67%
20%
163
Survival
87%
97%
85%
73%