Phase II study of allogeneic transplantation using transplant-lite conditioning regimes

Phase II study to assess the safety and efficacy of allogeneic transplantation using transplant-lite conditioning regimes (Fludarabine and Melphalan) in patients with a diagnosis of a haematological malignancy or metastatic renal cancer who are considered unsuitable for a standard conditioning regime due to age, poor physical status or previous exposure to high dose chemotherapy/radiotherapy.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000536662

Acronym

Transplant LITE

Enrollment

Registered

2005-09-28

Start date

2000-03-03

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

Fludarabine 25mg/kg day -7 to day -3 prior to Transplant Day 0. Melphalan 120mg/m2 day -2 prior to Transplant Day 0.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to 70 Years

Healthy volunteers

Inclusion criteria

Summary of Patient/Donor Eligibility Criteria:1. Diagnosis of haematological malignancy or metastatic renal cancer. 2. ECOG performance status 0-2. 3. Either a suitable HLA-identical sibling donor, fit for peripheral blood stem cell collection (cohort 1) or a suitable HLA-mismatched (single HLA mismatch) sibling donor, fit for peripheral blood stem cell collection, available HLA-identical (HLA-A,B,DRB1) unrelated donor or available HLA-mismatched (single HLA mismatch) unrelated donor (cohort 2).

Exclusion criteria

No exclusion criteria

Outcome results