cancer malignancy
Conditions
Interventions
The intervention applies to the selection of the donor source and preparation
of the grafts.
1) combining a cord blood unit with a minimum of > 1,5 x 10E7 NC/kg with
coinfused cells form a haplo-id
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: All of the following five criteria:;1) All patients qualifying for allogenic hematopoietic stem cell transplantation (HSCT) (based on national or international study protocols) with a malignancy and either: - Relapse after first transplant with a SIB or MUD/UCB donor - Having NHL or HD (refractory, *2CR) for which no standard allo-transplantation protocols are available, or ALL *CR2 if not eligible to other running SCT protocols. - Having relapse AML/ refractory AML - Problems finding a donor: no fully matched family donor or matched (9-10/10) unrelated donor available and / or no single or double unit cord blood available with sufficient cell numbers according to ongoing, open study protocols. 2) having a single matching (* 4/6) umbilical CB unit available with total NC count > 1,5 E7/kg [22] 3) Lansky / Karnofsky > 40 4) Age 0-65 * (*
Exclusion criteria
Exclusion criteria: - Lansky 1,5 x 10E7 Nucleated cells /kg -no informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The cumulative incidence of transplant related death (transplant related mortality: TRM, non-relapse mortality | — |
Secondary
| Measure | Time frame |
|---|---|
| - Engraftment: Neutrophils > 500K/uL for 3 consecutive days, Platelet (day 180 > 50 K) engraftment. - Event Free Survival (>6mths follow up). Event defined as: death, CB graft-failure ( | — |
Countries
Netherlands
Outcome results
None listed