Blood Transplantation for Patients With Hematologic Malig... | NCT00038779

Studies
Blood Transplantation for Patients With Hematologic Malignancies or Bone Marrow Failure States

NCT00038779

Sponsor

M.D. Anderson Cancer Center

Status

Terminated

Last Update Posted

Oct 30, 2018Actual

Enrollment

7Actual

Phase

Not Applicable

Conditions

Leukemia
Non Hodgkin's Lymphoma
Aplastic Anemia

Interventions

Megadose T-cell Depleted HLA-nonidentical Blood Progenitor 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

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of Accrual

Expanded Access Info

Start Date

Aug 14, 1996Actual

Primary Completion Date

Sep 20, 2004Actual

Completion Date

Sep 20, 2004Actual

First Submitted Date

Jun 5, 2002

First Submission Date that Met QC Criteria

Jun 6, 2002

First Posted Date

Jun 7, 2002Estimated

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

Oct 29, 2018

Last Update Posted Date

Oct 30, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to assess early treatment failure within 100 days and to assess the effect of this regimen on engraftment, GVHD, immune recovery, relapse of malignancy and survival.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Megadose T cell depleted	Experimental		Procedure: Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation	Procedure		Megadose T cell depleted

Eligibility Module

Eligibility Criteria

Patients with acute leukemia, lymphoma that failed to respond or relapsed after chemotherapy or CML beyond first chronic phase.
Patients with aplastic anemia or myelodysplasia which failed to respond to primary therapy are eligible.
Patients with low grade lymphoma or CLL will only be eligible if they failed two chemotherapy regimens and have stage IV disease.
Patients must be \

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

49 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MD Anderson Cancer Center		Houston	Texas	77030	United States

Condition Browse Module

MeSH Terms

ID	Term
D007938	Leukemia
D008228	Lymphoma, Non-Hodgkin
D000741	Anemia, Aplastic
D008223	Lymphoma

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided