NCT00144729

Brief Summary

A single arm dose optimization study in which all patients are given a fixed dose of Cytoxan (4 x 50 mg/kg) plus ATG (3 x 30 mg/kg) and the TBI dose starting at 3 x 200 cGy is escalated or de-escalated dependent upon engraftment and toxicity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 1993

Longer than P75 for phase_1

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

May 1, 1993

Completed
12.3 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

April 30, 2008

Status Verified

April 1, 2008

First QC Date

September 1, 2005

Last Update Submit

April 28, 2008

Conditions

Anemia, Aplastic

Outcome Measures

Primary Outcomes (1)

  • Sustained engraftment; survival

Secondary Outcomes (1)

  • Acute and chronic GVHD

Interventions

Bone marrow transplantPROCEDURE

Eligibility Criteria

AgeUp to 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Life-threatening marrow failure of nonmalignant etiology;
  • failure to respond to the best available immunosuppressive treatment;
  • lack of a HLA-identical family member

You may not qualify if:

  • Severe disease other than aplastic anemia that would severly limit the probability of survival during the graft procedure;
  • HIV seropositive patients;
  • clonal abnormalities or myelodysplastic syndrome;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Anemia, Aplastic

Interventions

Bone Marrow Transplantation

Condition Hierarchy (Ancestors)

AnemiaHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Failure DisordersBone Marrow Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Joachim Deeg, M.D.

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 5, 2005

Study Start

May 1, 1993

Study Completion

July 1, 2007

Last Updated

April 30, 2008

Record last verified: 2008-04

Locations

US(1)