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Completed

NCT Number: NCT00083694

Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia

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

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Key information

Conditions

Leukemia Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Arkansas for Medical Sciences/MIRT

Little Rock, Arkansas, 72205, United States

About this study

Patients will take Thalidomide tablets at bedtime daily until remission. The dose will be increased gradually and modified according to side-effects. The drug will be given daily up to the time of complete remission then as long as it is beneficial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

thalidomide

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

  • Celgene Corporation

Registry information

Official study title

UARK, 98-032, Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia

Important dates

Study start
1998
Study completion
2005
First posted
May 31, 2004
Registry last updated
Jul 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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