NCT00186342

Brief Summary

The purpose of this study is to determine the tolerability and efficacy in treating patients aged 51-60 with acute leukemia and in treating myelodysplastic syndromes (MDS) or myeloproliferative disorders (MPD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 1992

Longer than P75 for not_applicable

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

September 1, 1992

Completed
13 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
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

December 17, 2012

Status Verified

December 1, 2012

Enrollment Period

16.3 years

First QC Date

September 13, 2005

Last Update Submit

December 13, 2012

Conditions

Acute DiseaseMyelodysplastic SyndromesLeukemia, Myeloid, ChronicMyeloproliferative DisordersBlood and Marrow Transplant (BMT)Myelodysplastic Syndromes (MDS)Leukemia

Outcome Measures

Primary Outcomes (2)

  • tolerability

  • efficacy of therapy

Secondary Outcomes (1)

  • compare efficacy of this treatment to historical controls

Study Arms (1)

CIK cell

EXPERIMENTAL

The initial dose utilized will be 1x107 expanded cells/kg. The dose will be increased to 5x107 expanded cells/kg and 1x108 expanded cells/kg in successive escalations based on no significant infusional toxicity or GVHD.

Procedure: ablative allogeneic hematopoietic cell transplantation

Interventions

ablative allogeneic hematopoietic cell transplantationPROCEDURE
CIK cell

Eligibility Criteria

Age51 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \) Patients with myelodysplastic syndrome including patients with refractory anemia with excess blasts or refractory anemia with excess blasts in transformation.
  • \) Patients with myeloproliferative disorders which give them poor long-term disease-free survival, such as myeloid metaplasia or myeloid fibrosis.

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

Acute DiseaseMyelodysplastic SyndromesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMyeloproliferative DisordersLeukemia

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidNeoplasms by Histologic TypeNeoplasmsChronic Disease

Study Officials

  • Robert S Negrin

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Lymphatic Research and Medicine

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

September 1, 1992

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

December 17, 2012

Record last verified: 2012-12

Locations

US(1)