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Study Summary
No. 2003-0834:.......Leukemia......Susan O'Brien......Leukemia
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Study Summary Title
Study Summary
Number:		2003-0834
Study Title:A CRC Phase II Study of Subcutaneous Campath-1H in Patients with B-Cell Chronic Lymphocytic Leukemia and Residual Disease After Chemotherapy
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Physician New Patient Referral
Name:Susan O'BrienPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:LeukemiaReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-7543
Contact us about clinical trials
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General Information
Disease Group:LeukemiaSupported By:Berlex Laboratories
Phase of Study:Phase IIReturn
Visit:		One day every 3 months.
Treatment
Agents:		Collection
Questionaire
Campath-1H		Home Care:None needed.
Treatment Loc:outpatient
Estimated
Length of Stay
in Houston:		No hospitalization
Description/
Intervention:		Unavailable
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Study Objectives / Outcomes
Unavailable
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Study Status Information
Study Activation / Registration Date:03/04/2005
IRB Review and Approval Date:12/03/2003
Study Type:Therapeutic
Recruitment Status:Closed
Projected Accrual:30
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:Male or female, at least 18 years old

Signed informed consent

Zubrod performance status of 0, 1, or 2 (Appendix C)

Pt w/CLL, CLL/PLL or PLL (prolymphocytic) who has achieve clinical complete remission by NCI-WG crit w/chemotherapy, eg., alkylating agents, fludarabine or chemoimmunotherapy but have docu of resid disease by immunophenotying showing: a) resid popu of CD5 and CD19 + cells that comprise equal to/greater than 10% of marrow mononuclear cell popu or b) resid popu of CD5 and CD19 + cells that comprise less than 10% of marrow mononuclear cell and have Kappa/Lambda ratio greater than 6 or le ss than .33

Patients with CLL who have achieved a partial remission (PR) or nodular partial remission (nPR) by NCI-WG criteria after chemotherapy

Creatinine, bilirubin, AST or ALT and alkaline phosphatase less than or equal to 2 x the upper limit of normal
Exclusion Criteria:Active infection

Past history of anaphylaxis, following exposure to rat or mouse derived CDR-grafted humanized monoclonal antibodies

Less than 2 months since prior chemotherapy

Previous treatment with CAMPATH-1H

Pregnant or nursing women

Patients on corticosteroids

Uncontrolled autoimmune hemolytic anemia
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Links
Registration Number:
Other Links:
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Results

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