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

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00071396

Purpose

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.

Condition	Intervention	Phase
Chronic Lymphocytic Leukemia	Drug: Campath-1H Drug: Rituximab	Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Rituximab Alemtuzumab Campath

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment:	48
Study Start Date:	October 2002
Estimated Study Completion Date:	November 2005

Detailed Description:

Objectives:

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.
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.
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.

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 CLL, B-cell PLL, 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 either rituximab and/or Campath-

1H on different protocols but not in combination are eligible for the study.
Patients who have previously received either 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.
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 HBV infection and active HBV infection are excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00071396

Locations

United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Alessandra Ferrajoli, MD

M.D. Anderson Cancer Center

More Information

M.D. Anderson Cancer Center's website This link exits the ClinicalTrials.gov site

Study ID Numbers:	ID02-368
Study First Received:	October 21, 2003
Last Updated:	October 6, 2006
ClinicalTrials.gov Identifier:	NCT00071396
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Chronic Lymphocytic Leukemia
CD-52 and CD-20 Positive
Refractory
Relapsed

Study placed in the following topic categories:

Chronic lymphocytic leukemia
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Rituximab

Leukemia, Lymphocytic, Chronic, B-Cell
Alemtuzumab
Leukemia, B-cell, chronic
Lymphoproliferative Disorders
Leukemia, B-Cell

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009