NCT00186381

Brief Summary

Evaluate the role of high dose chemotherapy with autologous hematopoietic cell transplantation for AML.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 1995

Longer than P75 for phase_2

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

November 1, 1995

Completed
9.9 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

July 27, 2010

Status Verified

July 1, 2010

Enrollment Period

11.3 years

First QC Date

September 13, 2005

Last Update Submit

July 23, 2010

Conditions

Leukemia, Myelocytic, AcuteLeukemiaBlood and Marrow Transplant (BMT)

Outcome Measures

Primary Outcomes (1)

  • Disease free survival (DFS)

Secondary Outcomes (4)

  • Transplant related mortality (TRM)

  • Toxicity

  • Adequacy of cell collections

  • Engraftment kinetics

Interventions

high dose chemotherapy then autologous hematopoietic cell transplantPROCEDURE

Eligibility Criteria

Age16 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • active infection
  • liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteLeukemia

Condition Hierarchy (Ancestors)

Leukemia, MyeloidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Laura Johnston

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

November 1, 1995

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

July 27, 2010

Record last verified: 2010-07

Locations

US(1)