Conditioning Regimens for Patients With Severe Aplastic A... | NCT00144729

Studies
Conditioning Regimens for Patients With Severe Aplastic Anemia Transplanted With Marrow From an Unrelated Donor

NCT00144729

Sponsor

Fred Hutchinson Cancer Center

Status

Completed

Last Update Posted

Apr 30, 2008Estimated

Enrollment

Phase

Phase 1Phase 2

Conditions

Anemia, Aplastic

Interventions

Bone marrow transplant

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1993

Primary Completion Date

Not provided

Completion Date

Jul 2007Actual

First Submitted Date

Sep 1, 2005

First Submission Date that Met QC Criteria

Sep 1, 2005

First Posted Date

Sep 5, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2008

Last Update Posted Date

Apr 30, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Fred Hutchinson Cancer CenterOTHER

Collaborators

Name	Class
University of Minnesota	OTHER
University of California, Los Angeles	OTHER
City of Hope National Medical Center	OTHER
University of Utah

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Bone marrow transplant	Procedure

Measure	Description	Time Frame
Sustained engraftment; survival

Measure	Description	Time Frame
Acute and chronic GVHD

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

55 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joachim Deeg, M.D.	Fred Hutchinson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance		Seattle	Washington	98109	United States

Condition Browse Module

MeSH Terms

ID	Term
D000741	Anemia, Aplastic

Ancestor Terms

ID	Term
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D000080983	Bone Marrow Failure Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016026	Bone Marrow Transplantation

Ancestor Terms

ID	Term
D016378	Tissue Transplantation
D064987	Cell- and Tissue-Based Therapy
D001691	Biological Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
NIH# HL36444-21
IRB# 3632