Campath-1H Plus Rituximab for CD52- and CD20- Positive Refractory or Relapsed Chronic Lymphoid Disorders
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Campath-1H; Rituximab
Intervention description: 15 mg/day Continuous infusion by vein (IV) for 6 days then given twice a week for remaining three weeks as 30 mg injection under skin to complete one treatment course of 4 weeks.; 375 mg/m^2 IV infusion on day 1, then 500 mg/m^2 on days 8, 15, and 22.
Intervention MeSH terms: Rituximab; Alemtuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No
Keywords: Chronic Lymphocytic Leukemia; CD-52 and CD-20 Positive; Refractory; Relapsed

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age >/=15 years.

          2. Written informed consent.

          3. 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.

          4. 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).

          5. 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.

        Exclusion Criteria:

          1. Patients who have previously received Rituximab and CAMPATH-1H in combination are
             excluded.

          2. ECOG performance status of </= 2.

          3. Serum creatinine </= 2mg/dL and total bilirubin of £ 2 mg/dL unless due to direct
             infiltration of the liver or kidney with malignant cells.

          4. 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>.

          5. 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).

          6. 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.

          7. Patients at high risk of hepatitis B virus (HBV) infection and active HBV infection
             are excluded.