This is an open, non comparative, multicentre phase II trial, to evaluate the efficacy and feasibility of a newsequential combination of HD-MTX-AraC-based chemoimmunotherapy, followed by R-ICE regimen, and byhigh-dose chemotherapy supported by ASCT…
ID
Source
Brief title
Condition
- Lymphomas non-Hodgkin's B-cell
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1-year progression-free survival (PFS)
Secondary outcome
a. Complete remission rate before autologous stem cell transplantation
b. Response duration
c. Overall survival
d. Safety
Background summary
zie paragraaf 1.2 Background van het protocol (pagina 1)
Study objective
This is an open, non comparative, multicentre phase II trial, to evaluate the
efficacy and feasibility of a new
sequential combination of HD-MTX-AraC-based chemoimmunotherapy, followed by
R-ICE regimen, and by
high-dose chemotherapy supported by ASCT.
Study design
Open, non comparative, multicentre phase II trial,
Intervention
All patients will be treated with Matrix (3 courses, R-ICE (3 courses),
conditioning and autologous stem cell transplant.
Study burden and risks
Intensive treatment witth chemotherapy requires several hospital admissions.
This is necessary to safely administer the chemotherapy, to observe the patient
and to monitor side effects. this is common for most intensive treatments in
hematology. Methotrexate can induce renal insufficiency and all chemotherapy
can induce neutropenia and complications of infectious nature.
Ospedale San Giovanni .
Bellinzona 6500
CH
Ospedale San Giovanni .
Bellinzona 6500
CH
Listed location countries
Age
Inclusion criteria
- Histologically confirmed diagnosis of diffuse large B-cell lymphoma
- CNS involvement (brain, meninges, cranial nerves, eyes and/or spinal cord) at diagnosis (concomitant to extra-CNS disease) at diagnosis or relapse after conventional chemo(-immuno)therapy
- Diagnosis of CNS involvement either by brain biopsy or CSF cytology examination. Neuroimaging alone is acceptable when stereotactic biopsy is formally contraindicated or when the disease has been previously histologically documented in other areas and the CNS localization is concomitant with a diffuse progression of systemic disease.
- No previous treatment with high-dose methotrexate-based chemotherapy and/or brain irradiation. One-two courses of R-CHOP combination as upfront therapy are admitted in patients with large amount and/or extensive extra-CNS disease that could condition prognosis in an early phase of treatment. Local investigator decides if initial R-CHOP is needed based on patient*s conditions
- Age 18-70 years
- ECOG performance status 0-3
- written informed consent
Exclusion criteria
- Other lymphoma categories other than diffuse large B-cell lymphoma. In particular, patients with primary mediastinal lymphoma, intravascular large B-cell lymphoma or leg-type large B-cell lymphoma are excluded.
- Patients with positive flow cytometry examination of the CSF, but negative results in CSF conventional cytology, and without any other evidence of CNS disease.
- Patients with exclusive CNS disease at presentation (primary CNS lymphoma) are excluded
- Previous treatment with support of autologous or allogeneic stem cells/bone marrow transplantation.
- Symptomatic coronary artery disease, cardiac arrhythmias not well controlled with medication or
myocardial infarction within the last 6 months (New York Heart Association Class III or IV heart disease)
- Any other serious medical condition which could impair the ability of the patient to participate in the trial.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-003031-19-NL |
| CCMO | NL54212.078.16 |