Evaluation of engraftment kinetics following double unit umbilical cord blood transplantation in patients with life threatening haematological malignancy in whom stem cell transplant (SCT) offers the only prospect of cure.

Phase 2

Withdrawn

• Conditions: High risk haematological malignancy; Blood - Haematological diseases

• Registration Number: ACTRN12606000303549
• Lead Sponsor: Australasian Leukaemia and Lymphoma Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-14
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. H\Patients with high risk haematological malignancy in whom stem cell transplant offers the only prospect of cure, but do not have either a fully matched or one-antigen mismatched related donor or an identified suitable matched unrelated donor (URD).2. ECOG performance status 0-2. 3. Satisfactory major organ function- Cardiac function as measured by either a gated blood pool scan or echocardiogram showing left ventricular ejection fraction > 40%.- Pulmonary function as measured by a DLCO ³ 50% of normal.- Renal function as measured by a calculated or actual creatinine clearance > 30 ml/min.- Hepatic function as measured by a serum bilirubin greater than or equal to 30 micromol/l and transaminases greater than or equal to 2 x ULN. 4. Absence of severe uncontrolled infection. 5. Written informed consent given by recipient.

Exclusion Criteria

1. Patients with a suitable matched related or unrelated donor in whom marrow or peripheral blood stem cells can be procured within a satisfactory time period.2. Patients who are positive for hepatitis B, hepatitis C or HIV.3. Pregnant or lactating women.4. No contraindication to use of any of the study drugs, including known sensitivity to E coli derived preparations.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To estimate the time to neutrophil and platelet engraftment of double unit unrelated cord blood transplantation in adult patients with high risk malignancy. Specifically, to analyse the ability of a two unit cord blood transplant with Filgrastim support to achieve timely engraftment.[Donor chimerism at days 28, 56, 100, 180, 270 and 365 will be reported for each of these time points in the form of summary statistics]

Secondary Outcome Measures

Name	Time	Method
To assess chimerism[Chimerism will be measured at days 30, 60, 90, 180, 360, 540 and 730 post-transplantation.];Graft vs host disease (GVHD)[GVHD will be measured at the dates of diagnosis, histopathology and therapy with response and then on days 100, 180, 365.];Toxicity and safety[Toxicity and safety will be measured as clinically indicated.];Disease free survival (DFS) and overall survival (OS) [Disease free survival and overall survival will be measured at days 28, 100, 180, 365, 730 and other timepoints as clinically indicated.]