Clinical Trials/NCT00916045

NCT00916045

Terminated

Phase 2

Pilot Study of Unrelated Cord Blood Transplantation in Patients With Poor Risk Haematological Malignancies

King's College Hospital NHS Trust1 site in 1 country40 target enrollmentSeptember 2009

Overview

Phase: Phase 2
Intervention: Thymoglobulin
Conditions: Leukemia, Myeloid, Acute
Sponsor: King's College Hospital NHS Trust
Enrollment: 40
Locations: 1
Primary Endpoint: Treatment related mortality at day 100
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the safety and feasibility of unrelated double and single cord blood transplantation in patients with haematological malignancies using reduced-intensity or myeloablative conditioning regimens.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

March 2012

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

King's College Hospital NHS Trust

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•reduced-intensity conditioning regimen (For both FluMel \& FluCyTBI regimens):
•Patients with an available 5-6/6 HLA-A, -B, -DRB1 matched sibling donor or 10/10 unrelated bone marrow donor
•ECOG performance status worse than 2
•Cardiac insufficiency requiring treatment, symptomatic coronary artery disease or LVEF less than 35%.
•Hepatic disease, with total bilirubin greater than 2 times upper limit of normal or AST \> 5 times upper limit of normal.
•Severe hypoxaemia, pO2 \< 70 mm Hg, with decreased DLCO \< 50% of predicted; or mild hypoxemia, pO2 \< 80 mm Hg with severely decreased DLCO \< 50% of predicted.
•Impaired renal function (creatinine \> 2 times upper limit of normal or creatinine clearance \< 50% for age, gender, weight).
•Previous irradiation that precludes the safe administration of an additional dose of 200 cGy of total body irradiation (TBI).
•Patients who have received previous treatment with Thymoglobulin®
•HIV or HTLV positive patients.

Arms & Interventions

Reduced intensity conditioning regimen - FluMel

Intervention: Thymoglobulin

Myeloblative conditioning regimen

Intervention: Thiotepa

Myeloblative conditioning regimen

Intervention: Fludarabine

Myeloblative conditioning regimen

Intervention: Intravenous busulphan

Myeloblative conditioning regimen

Intervention: Thymoglobulin

Myeloblative conditioning regimen

Intervention: Ciclosporin

Myeloblative conditioning regimen

Intervention: Mycophenolate mofetil (MMF)

Reduced intensity conditioning regimen - FluCyTBI

Intervention: Fludarabine

Reduced intensity conditioning regimen - FluCyTBI

Intervention: Cyclophosphamide

Reduced intensity conditioning regimen - FluCyTBI

Intervention: Radiotherapy

Reduced intensity conditioning regimen - FluCyTBI

Intervention: Thymoglobulin

Reduced intensity conditioning regimen - FluCyTBI

Intervention: Ciclosporin

Reduced intensity conditioning regimen - FluCyTBI

Intervention: Mycophenolate mofetil (MMF)

Reduced intensity conditioning regimen - FluMel

Intervention: Fludarabine

Reduced intensity conditioning regimen - FluMel

Intervention: Melphalan

Reduced intensity conditioning regimen - FluMel

Intervention: Ciclosporin

Reduced intensity conditioning regimen - FluMel

Intervention: Mycophenolate mofetil (MMF)

Outcomes

Primary Outcomes

Treatment related mortality at day 100

Time Frame: Day 100

Secondary Outcomes

Incidence of grade II-IV and III-IV acute GVHD(Days 28, 56, 100 and months 6, 9, 12, 18 and 24)
Dynamics of EBV infection and immunity following cord blood transplantation(Days 14, 28, 56, 100 and months 6, 9 and 12)
The development (if any) of transplant associated post transplant lymphoproliferative disease (PTLD)(Days 14, 28, 56, 100 and months 6, 9 and 12)
One year overall survival for each treatment cohort(1 year)
Incidence of CMV, adenovirus and EBV activation(Twice a week pre-transplant to day 100 then weekly or as clinically indicated)
Immune reconstitution(Days 14, 28, 56, 100 and months 6, 9, 12, 18 and 24)
Incidence of one year relapse or disease progression for each treatment cohort(1 year)
Chimerism(Days 14 (myeloblative conditioning only), 28, 56, 100 and months 6 and 12)
Incidence of chronic GVHD during the first year(Day 100 and months 6 and 12)
Quality of life(Pre-transplant and months 6, 12, 18 and 24)
Incidence of platelet engraftment by 6 months(Days 14, 28, 56, 100 and month 6)
Disease free survival at one year post-transplant for each cohort(1 year)
Incidence of neutrophil engraftment by day 42(Days 14, 28 and 42)
Incidence of systemic infections(Twice a week pre-transplant to day 100 then weekly or as clinically indicated)
Identify any possible predictive markers for patients most at risk of PTLD development(Days 14, 28, 56, 100 and months 6, 9 and 12)