Campath-1H Plus Rituximab for CD52- and CD20- Positive Refractory or Relapsed Chronic Lymphoid Disorders

Completed · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia

In brief

The goal of this clinical research study is to learn if giving CAMPATH-1H with rituximab can shrink or slow the growth of the disease in patients with chronic lymphoid disorders that have either not responded or whose disease has returned after treatment with standard therapies.

Key facts

Study ID

NCT00071396

Run by

M.D. Anderson Cancer Center

People needed

48

Starts

2002-10-01

Expected to finish

2007-08-01

Last updated by the study team

2012-08-07

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >/=15 years.
• Written informed consent.
• Patients with chronic lymphoid malignancies that are either refractory to frontline therapy or have relapsed and that have a predicted probability of response of less than 20% with conventional therapy or allogeneic/autologous stem cell transplantation.
• The following histologies are included: B-cell chronic lymphocytic leukemia (B-CLL or B-cell CLL), B-cell prolymphocytic leukemia (PLL), chronic lymphoid leukemia (CLL/PLL), hairy cell leukemia and hairy cell variant, mantle cell leukemia/lymphoma, marginal zone lymphoma/leukemia, splenic lymphoma with villous lymphocytes, CLL with evidence of transformation (e.g., Richter's transformation), large granular lymphocytic leukemia (LGL and NK-cell type).
• Patients with above mentioned histologies whose malignant cell population have expressed both CD52 and CD20 in >/= 20% of cells as assessed by flow cytometry or immunohistochemistry. Expression of CD20 or CD52 < 20% is permitted if patients received rituximab or alemtuzumab, respectively, within 3 months prior to study start.

You may not qualify if…

• Patients who have previously received Rituximab and CAMPATH-1H in combination are excluded.
• ECOG performance status of </= 2.
• Serum creatinine </= 2mg/dL and total bilirubin of £ 2 mg/dL unless due to direct infiltration of the liver or kidney with malignant cells.
• Patients with a past history of anaphylaxis following exposure to rat or mouse derived CDR-grafted humanized monoclonal antibodies are excluded <CDR = complementarity determining regions>.
• Negative pregnancy test (serum or urine) if female and of childbearing potential only (non-childbearing is defined as greater than one year post-menopausal or surgically sterilized).
• No prior chemotherapy, immunotherapy, or hormonal therapy within 2 weeks prior to study start. Hormonal replacement therapy is permitted. No prior therapy with monoclonal antibodies for at least 4 weeks prior to study start.
• Patients at high risk of hepatitis B virus (HBV) infection and active HBV infection are excluded.

Where it is running

• University of Texas - MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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