NCT00038779

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable leukemia

Timeline
Completed

Started Aug 1996

Longer than P75 for not_applicable leukemia

Geographic Reach
1 country

1 active site

Status
terminated

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

August 14, 1996

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2002

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2004

Completed
Last Updated

October 30, 2018

Status Verified

October 1, 2018

Enrollment Period

8.1 years

First QC Date

June 5, 2002

Last Update Submit

October 29, 2018

Conditions

LeukemiaNon Hodgkin's LymphomaAplastic Anemia

Keywords

LymphomaCMLCLLAMLALLMDSAA

Study Arms (1)

Megadose T cell depleted

EXPERIMENTAL
Procedure: Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation

Interventions

Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell TransplantationPROCEDURE
Megadose T cell depleted

Eligibility Criteria

AgeUp to 49 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
* 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 \<age 50 with a related haploidentical donor (phenotypically one, two or three HLA A, B and DR antigen mismatched) donor. * Patients should have adequate hepatic and renal function with a bilirubin of less than or equal to 1.5mg%, SGPT less than or equal to 3x the upper limits of normal, and creatine less than or equal to 1.5mg%. * Patients with serious intercurrent medical illness are not eligible. * Patients and their donors must provide written informed consent.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

LeukemiaLymphoma, Non-HodgkinAnemia, AplasticLymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesAnemiaBone Marrow Failure DisordersBone Marrow Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2002

First Posted

June 7, 2002

Study Start

August 14, 1996

Primary Completion

September 20, 2004

Study Completion

September 20, 2004

Last Updated

October 30, 2018

Record last verified: 2018-10

Locations

US(1)