Study of Subcutaneous Campath-1H in Patients With B-Cell CLL and Residual Disease After Chemotherapy

Status unconfirmed · Phase 2

Conditions studied: B-Cell Chronic Lymphocytic Leukemia

In brief

To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to chemotherapy will: a) eliminate minimal residual disease (documented by flow cytometry) in patients who have achieved a complete remission (CR) or b) convert partial remission to complete remission. To evaluate the time-to-progression of patients according to pretreatment characteristics and response status at study entry. To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to chemotherapy will eliminate minimal residual disease as determined by real-time quantitative PCR.

Key facts

Study ID

NCT00800943

Run by

Chronic Lymphocytic Leukemia Research Consortium

People needed

31

Starts

2003-12-01

Expected to finish

2010-08-01

Last updated by the study team

2008-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, at least 18 years old.
• Signed informed consent.
• Zubrod performance status of 0, 1, or 2 (Appendix C).
• Patients with CLL, CLL/PLL or PLL (prolymphocytic) who have achieved a clinical complete remission by NCI-WG criteria with chemotherapy, eg., alkylating agents, fludarabine or chemoimmunotherapy but have documentation of residual disease by immunophenotyping showing: (a) a residual population of CD5 and CD19 positive cells that comprise ≥ 10% of the marrow mononuclear cell population; or (b) a residual population of CD5 and CD19 positive cells that comprise <10% of the marrow mononuclear cells and have a Kappa/Lambda ratio >6 or <.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 ≤2 x the upper limit of normal.

You may not qualify if…

• 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.

Where it is running

• University of California San Diego — La Jolla, California, United States
• Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute — Boston, Massachusetts, United States
• M. D. Anderson Cancer Center at University of Texas — Houston, Texas, United States

Full record on ClinicalTrials.gov

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