NCT00382759

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2000

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 2, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

August 3, 2009

Status Verified

July 1, 2009

Enrollment Period

7 years

First QC Date

September 29, 2006

Last Update Submit

July 31, 2009

Conditions

Hematological Malignancies

Outcome Measures

Primary Outcomes (3)

  • overall survival

  • progression-free survival

  • transplant-related mortality

Secondary Outcomes (2)

  • acute GVHD

  • chronic GVHD

Interventions

stem cell transplantPROCEDURE

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • lack of an HLA-identical sibling donor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale San Giovanni Battista

Torino, 10126, Italy

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • michele falda, md

    ospedale san giovanni battista

    PRINCIPAL INVESTIGATOR

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 29, 2006

First Posted

October 2, 2006

Study Start

March 1, 2000

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

August 3, 2009

Record last verified: 2009-07

Locations

IT(1)