Nonmyeloablative Stem Cell Transplant in Elderly

NCT ID: NCT00382759

Last Updated: 2009-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-03-31

Study Completion Date

2007-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study aimed to evaluate the efficacy of a nonmyeloablative conditioning consisting of fludarabine and total body irradiation in patients older than 60 years of age

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A total of 35 patients with hematological malignancies were treated with fludarabine (30 mg/m2 x 3-5 days) and 200 cCy TBI followed by allogeneic hematopoietic stem cell transplantation (HSCT) from a matched-sibling donor.

Neutrophil recovery occurred in 89% of the patients at a median time of 15 days. On day +30, 10 patients had \> 95% donor chimerism, and 21 patients had mixed chimerism. The cumulative probabilities of grade II-IV acute GVHD and chronic GVHD were 51% and 84% respectively. Transplant-related mortality at 100 days and 1 year was 5% and 9% respectively. The probabilities of 1-year overall (OS) and progression-free survival (PFS) were 55% and 47% respectively. The estimated 1-year probability of OS and PFS for patients in early disease stages were 87% and 74% respectively , which were significantly higher than the survival and PFS estimates of 12% obtained in patients with advanced disease stages at the time of transplant

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hematological Malignancies

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

stem cell transplant

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients with myeloid or lymphoid malignancy who were \> 60 years old potentially treatable with stem cell transplant

Exclusion Criteria

* lack of an HLA-identical sibling donor
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Azienda Ospedaliera San Giovanni Battista

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

michele falda, md

Role: PRINCIPAL_INVESTIGATOR

ospedale san giovanni battista

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ospedale San Giovanni Battista

Torino, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

012000

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.