Overview

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

Status:
Completed
Trial end date:
2007-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Bayer
Treatments:
Alemtuzumab
Rituximab
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
3. Serum creatinine 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 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.