Stem Cell Transplant From Matched Unrelated or Partially... | NCT00186225

Studies
Stem Cell Transplant From Matched Unrelated or Partially Matched Related Donors

NCT00186225

Sponsor

Stanford University

Status

Completed

Last Update Posted

Apr 9, 2020Actual

Enrollment

250Estimated

Phase

Not Applicable

Conditions

Blood Cancer
Blood and Marrow Transplant (BMT)

Interventions

ablative allogeneic hematopoietic cell transplantation

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

ID	Type	Description	Link
75268	Other Identifier	Old IRB number
BMT22	Other Identifier	OnCore

Status Module

Record Verification Date

Apr 2020

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

Nov 1989

Primary Completion Date

Jun 2007Actual

Completion Date

May 2010Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 16, 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 7, 2020

Last Update Posted Date

Apr 9, 2020Actual

Description Module

Brief Summary

To evaluate the use of unrelated donors for hematopoietic cell transplantation in the treatment of hematologic and lymphoid malignancies.

Detailed Description

Stem Cell Transplantation from Matched Unrelated or Partially Matched Related Donors Using a Preparatory Regimen Consisting of Fractionated Total Body Irradiation (FTBI) and Cyclophosphamide (CY). To administer high dose radio-chemotherapy followed by stem cell transplantation from a matched unrelated donor or a partially matched related donor.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Name	Type	Description	Arm Group Labels	Other Names
ablative allogeneic hematopoietic cell transplantation	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
oxicity and efficacy of TBI and cyclophosphamide as preparation for hematopoietic cell transplantation from partially matched and unrelated donors.

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival
Event Free Survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:- acute leukemia

chronic leukemia
lymphoblastic lymphoma
MDS
MPS Exclusion Criteria:- organ dysfunction
HIV positive

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Weeks

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laura Johnston	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Medicine		Stanford	California	94305	United States

Condition Browse Module

MeSH Terms

ID	Term
D019337	Hematologic Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided