Long-term results after transplantation of CD34+ selected (CellPro) versus unselected peripheral blood progenitor cells (PBPC) from related allogeneic donors.
OBJECTIVE
To determine the long-term outcome of patients after allogeneic transplantation of T-cell depleted versus unmanipulated hematopoietic stem cell grafts with respect to incidence of GvHD and overall survival in 50 consecutive patients.


METHODS
In this prospective phase II study utilizing biological randomization, 50 sibling donors were mobilized with G-CSF. Positive selection of CD34+ cells (Ceprate SC; CellPro, USA) was performed in good mobilizers (n = 25; group A), but not in poor mobilizers (n = 25; group B). Patients had hematological malignancies. Median patient age was 44 years (range, 19-57). Numbers of CD3+ cells were 0.5 ± 0.4 × 10(6)/kg in group A and 216 ± 127 × 10(6)/kg in group B.


RESULTS
Hematological recovery was rapid in both groups. Patients in group A had no grade III-IV acute GvHD, whereas 6 out of 22 evaluable patients in group B had grade III-IV acute GvHD with fatal outcome in four cases (P < 0.01). Similarly, the incidence of chronic GvHD was lower in patients in group A (35 vs. 65%). However, there was a higher relapse rate in group A (11/25) versus group B (4/25, P < 0.05). At a follow-up of 10 years after transplantation, eight (32%) and 10 patients (40%) were relapse-free and alive in groups A and B, respectively.


CONCLUSIONS
Risk factors for survival in a multivariate analysis were remission status prior to transplantation (CR vs. no CR), occurrence of acute and chronic GvHD, and relapse. The use of the CellPro device for CD34 positive selection per se did not have an influence on overall survival.
Kopp
Hans-Georg
HG
Department of Internal Medicine II, Division of Hematology and Oncology, Immunology, and Rheumatology, University of Tübingen, Tübingen, Germany.
Wirths
Stefan
S
Faul
Christoph
C
Bethge
Wolfgang
W
Scheding
Stefan
S
Brugger
Wolfram
W
Kanz
Lothar
L
Vogel
Wichard
W
D000328:Adult; D018952:Antigens, CD34 / Q000097:blood*; D005500:Follow-Up Studies; D006086:Graft vs Host Disease / Q000209:etiology; D019337:Hematologic Neoplasms / Q000601:surgery; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods*; D006412:Hematopoietic Stem Cells / Q000166:cytology / Q000378:metabolism*; D006801:Humans; D008875:Middle Aged; D015999:Multivariate Analysis; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D035781:Siblings; D013997:Time Factors; D014019:Tissue Donors; D014184:Transplantation, Homologous; D016896:Treatment Outcome; D055815:Young Adult
D018952:Antigens, CD34