CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 102 enrolled
Drug / intervention
Geriatric assessment adapted therapy +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00475280
NCT00475280Phase 2Completed

"Geriatric Assessment Adapted" Therapy for Ph- ALL Elderly Patients. GIMEMA Protocol LAL1104. EudraCT Code 2005-002156-17

Gruppo Italiano Malattie EMatologiche dell'Adulto·interventional·Posted May 21, 2007·Updated Oct 12, 2022

In Brief

A Phase 2 clinical trial evaluating Geriatric assessment adapted therapy and Stem cells autotransplantation for Leukemia, Lymphoblastic, Acute. Completed, enrolled 102 participants across 32 sites.

Detailed Summary

This study aims at considering clinical heterogeneity of patients based on a "geriatric assessment" without taking into account the real age of the subject. This will allow physicians to adapt therapy according to three different groups of patients: frail, fit and intermediate and to evaluate the efficacy and feasibility of a therapy adapted to the different categories of patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 21, 2007
Enrollment StartNov 1, 2007
Primary CompletionDec 1, 2016
Study CompletionJan 28, 2020
TodayJul 2, 2026
Enrollment to primary: 9.1 yearsPosted 19.1 years ago

Interventions

Geriatric assessment adapted therapyprocedure

Geriatric assessment is performed before the induction phase starts.

Stem cells autotransplantationprocedure

Stem cells autotransplantation is performed after consolidation treatment