NCT00083694

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Thalidomide in patients with leukemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_2 leukemia

Timeline
Completed

Started Aug 1998

Typical duration for phase_2 leukemia

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

August 1, 1998

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 31, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
Last Updated

July 2, 2010

Status Verified

July 1, 2010

First QC Date

May 27, 2004

Last Update Submit

July 1, 2010

Conditions

Leukemia

Keywords

LeukemiaThalidomiderelapsed

Outcome Measures

Primary Outcomes (1)

  • To evaluate the efficacy and safety of Thalidomide in patients with leukemia.

Interventions

ThalidomideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of refractory or relapsed leukemia: acute leukemia, CML, CLLm and MDS.
  • Signed informed consent, including patient agreeing to use safe contraceptive methods during the treatment and for at least 4 months after the treatment is completed
  • Serum creatinine \< or = 2.5mg/dL
  • Serum bilirubin\< or = 2.5mg/dL
  • Negative pregnancy test
  • Age 18 years or older
  • Performance status \< or = 3

You may not qualify if:

  • Pregnant or lactating women
  • Concurrent treatment with cytotoxic chemotherapy, or radiation
  • History of seizures, neurotoxicity, or active CNS disease
  • Serious infections not controlled by antibiotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences/MIRT

Little Rock, Arkansas, 72205, United States

Location

Related Links

MeSH Terms

Conditions

LeukemiaRecurrence

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Barthel Barlogie, M.D., Ph.D.

    UAMS

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 27, 2004

First Posted

May 31, 2004

Study Start

August 1, 1998

Study Completion

May 1, 2005

Last Updated

July 2, 2010

Record last verified: 2010-07

Locations

US(1)