NCT00210366

Brief Summary

The main objective of the trial is to assess the therapeutic activity of idarubicin as salvage treatment in patients with recurrent or progressive lymphoma in the central nervous system.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Last Updated

July 30, 2010

Status Verified

July 1, 2010

Enrollment Period

5.7 years

First QC Date

September 13, 2005

Last Update Submit

July 29, 2010

Conditions

Lymphoma, B-Cell

Outcome Measures

Primary Outcomes (1)

  • objective response to treatment

Secondary Outcomes (3)

  • duration of response

  • overall survival

  • acute side effects of idarubicin

Interventions

IdarubicinDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histological or cytological diagnosis of non-Hodgkin's lymphoma
  • Disease exclusively localised into the CNS at first diagnosis and failure
  • Progressive or recurrent disease
  • Previous treatment with HDMTX containing CHT and/or RT
  • Presence of at least one target lesion, bidimensionally measurable
  • Age 18 - 75 years
  • ECOG performance status \< 3 (Appendix 1).
  • No known HIV disease or immunodeficiency
  • HBsAg-negative and Ab anti-HCV-negative patients.
  • Adequate bone marrow function (plt \> 100000 mm3, Hb \> 9 g/dl, ANC \> 2.000 mm3)
  • Adequate renal function (serum creatinine \< 2 times UNL)
  • Adequate hepatic function (SGOT/SGPT \< 3 times UNL, bilirubin and alkaline phosphatase \< 2 times UNL)
  • Adequate cardiac function (VEF ≥ 50%)
  • Absence of any psycological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Non-pregnant and non-lactating status for female patients. Adequate contraceptive measures during study participation for sexually active patients of childbearing potential.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Servizio Radiochemioterapia - Ospedale San Raffaele

Milan, Milan, 20132, Italy

Location

Related Links

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

Idarubicin

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Andres JM Ferreri, MD

    San Raffaele Hospital - HSR Servizio di radiochemioterapia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

November 1, 2004

Primary Completion

July 1, 2010

Last Updated

July 30, 2010

Record last verified: 2010-07

Locations

IT(1)