Phase II study of myeloablative allogeneic transplantation using pegylated G-CSF mobilised peripheral blood stem cells.

A Phase I/II trial to evaluate the effects of allogeneic pegylated G-CSF mobilized stem cells in the treatment of haematological malignancy to inhibit the incidence of GVHD.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000460606

Acronym

BMT Neulasta

Enrollment

Registered

2005-09-22

Start date

2004-01-19

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

All donors will receive 12mg of pegylated G-CSF as a single dose sub-cutaneously 4 days prior to stem cell collection.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to 70 Years

Healthy volunteers

Inclusion criteria

Diagnosis of haematological malignancy.Allogeneic peripheral blood stem cell transplant from an HLA identical sibling.Ablative conditioning regime (CY/TBI, BU/CY, FLU/MEL). ECOG performance status 0-2.Suitable HLA-identical sibling donor, fit for peripheral blood stem cell collection.

Exclusion criteria

No exclusion criteria

Outcome results