Know Cancer

or
forgot password

Continuous Infusion Followed by Subcutaneous Injection of Campath-1H Plus Rituximab in the Treatment of CD52- and CD20-Positive Refractory or Relapsed Chronic Lymphoid Disorders


Phase 2
15 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia

Thank you

Trial Information

Continuous Infusion Followed by Subcutaneous Injection of Campath-1H Plus Rituximab in the Treatment of CD52- and CD20-Positive Refractory or Relapsed Chronic Lymphoid Disorders


Objectives:

1. To determine the efficacy and response rates of Campath-1H when given as a continuous
intravenous infusion followed by subcutaneous injection plus rituximab in the treatment
of chronic lymphoid disorders that are refractory to conventional therapy, have
relapsed, or have no established frontline therapy.

2. To assess the safety of the combination of Campath-1H when given as a continuous
intravenous infusion followed by subcutaneous injection plus rituximab in chronic
lymphoid disorders that express both CD52 and CD20 cell surface antigens.

3. To measure levels of soluble (s) CD20 and sCD52 as well as levels of Campath-1H,
rituximab and antibody complexes of rituximab/CD20 and Campath-1H/CD52 in patients with
chronic lymphoid disorders treated with Campath-1H plus rituximab.


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 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response

Outcome Description:

Overall response categorized as 'Complete Remission,' 'Partial Remission,' or 'No Response.' Blood tests weekly while on active therapy, within 4-6 weeks following last dose of therapy, and every 3 to 6 (+/- month) thereafter as long as on study. Repeat bone marrow biopsy/aspirate with flow cytometry as applicable at the end of first course of therapy, (1 week) within 4-6 weeks following the last dose of therapy and every 6 to 12 months (+/-) thereafter as long as on study.

Outcome Time Frame:

After each 4 week course of treatment

Safety Issue:

Yes

Principal Investigator

Alessandra Ferrajoli, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

ID02-368

NCT ID:

NCT00071396

Start Date:

October 2002

Completion Date:

August 2007

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Chronic Lymphocytic Leukemia
  • CD-52 and CD-20 Positive
  • Refractory
  • Relapsed
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009