Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refr... | NCT00083694

Studies
Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia

NCT00083694

Sponsor

University of Arkansas

Status

Completed

Last Update Posted

Jul 2, 2010Estimated

Enrollment

Phase

Phase 2

Conditions

Leukemia

Interventions

Thalidomide

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Aug 1998

Primary Completion Date

Not provided

Completion Date

May 2005

First Submitted Date

May 27, 2004

First Submission Date that Met QC Criteria

May 28, 2004

First Posted Date

May 31, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2010

Last Update Posted Date

Jul 2, 2010Estimated

Name	Class
Celgene Corporation	INDUSTRY

Description Module

Brief Summary

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

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Thalidomide	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the efficacy and safety of Thalidomide in patients with leukemia.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Barthel Barlogie, M.D., Ph.D.	UAMS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Arkansas for Medical Sciences/MIRT		Little Rock	Arkansas	72205	United States

Label	URL
Myeloma Institute for Research \& Therapy website	View source

Condition Browse Module

MeSH Terms

ID	Term
D007938	Leukemia
D012008	Recurrence

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013792	Thalidomide

Ancestor Terms

ID	Term
D010797	Phthalimides
D010795	Phthalic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids

Browse Leaves

Not provided

Browse Branches

Not provided