Phase II study of low intensity allogeneic transplantation in Mantle Cell Lymphoma
- Conditions
- Mantle Cell Lymphoma (MCL) is an increasingly recognised yet rare sub-type of non-hodgkin's Lymphoma (NHL), representing between 5 and 8% of all cases. Typically a disease of the elderly with a median age of presentation above 60 years the prognosis is generally poor. Although characterised a 'Low Grade Lymphoma' within the Working Formulation, the five year survival is around 27% which identifies it as one of the worst sub-types of disease.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2007-003081-18-GB
- Lead Sponsor
- niversity College Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion criteria for registration:
- At least 18 years of age and considered fit for a transplant by the treating physician
- A confirmed diagnosis of MCL:
MCL must be proven by a histological examination of representative material (lymph nodes or bone marrow) together with a typical immunophenotype CD5+, CD23-, Slgm
Central review of histology is mandatory
NB: Molecular/cytogenetic confirmation of diagnosis is desirable but not mandatory
- No concurrent serious medical condition that would preclude an allograft
- Evidence of PR/CR following prior therapy
- Staging diagnosis and staging to prove response.
Inclusion criteria for proceeding to allograft:
- A HLA matched donor
- Patients in complete or partial remission (using standard criteria) following initial chemotherapy
- Written, informed consent
- Peripheral blood (20ml EDTA) or a buccal swab if this is the local practice from both the donor and patient must be available for chimerism studies prior to the transplant.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
Exclusion criteria for registration:
- Relapsed or progressive disease
- Previous malignancy in the past 5 years, except non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma
- Known serological positivity for HIV or evidence of potentially infectious HBV (DNAemia, HBsAG) or HCV (RNAemia)
- Patients with a history of a psychological illness or condition that in the opinion of the investigator may adversely affect compliance with planned therapy
Exclusion criteria for proceeding to an allograft:
- Impaired renal function: creatinine clearance < 50mls/min
- Impaired hepatic function: serum bilirubin > 1.5 x upper limit of normal or alkaline phosphatase > 2 x normal
- Inadequate cardiac function (ejection fraction must be > 50% if assessed by ECHO or >40% if assessed by radionuclide ventriculography)
- ECOG score >2
- Symptomatic respiratory compromise
- Central nervous system involvement
- Pregnant or lactating women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: This study will examine the use of an upfront RIC transplant procedure in younger patients with MCL. The primary objective is disease free survival.;Secondary Objective: Toxicity and overall survival. ;Primary end point(s): Progression free survival.;Timepoint(s) of evaluation of this end point: Through treatment and follow up
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Overall Survival and Toxicity;Timepoint(s) of evaluation of this end point: Treatment and follow up