Protocol Number: 06-H-0228

Title:

A Pilot Study of Fractionated Dose Subcutaneous Rituximab (RTX, Rituxan® (Registered Trademark)) in Patients with Refractory or Relapsed Chronic Lymphocytic Leukemia

Number:

06-H-0228

Summary:

This study will test the safety and effectiveness of using lower-dose rituximab given more frequently for treating chronic lymphocytic leukemia (CLL). Studies have shown that, used once a week for 4 weeks, rituximab was effective in up to 25 percent of patients with CLL. New evidence shows that using lower and more frequent doses of rituximab can be more effective in destroying leukemia cells and produce a better treatment response.

Patients 21 years of age and older with CLL who have received treatment with fludarabine may be eligible for this study.

Participants take rituximab for 12 weeks. One dose of the drug is infused through an arm vein over about 30 minutes on either day 1 (the first dose) or day 3 (the second dose). All other doses are given as an injection under the skin. After the first week, patients can choose to do these injections at home. Rituximab will be given 3 times a week for a total of 12 weeks. Other medications are given to reduce the side effects and allergic reactions to the drug. In addition to treatment, patients undergo the following tests and procedures:

Before treatment

-Medical history, physical examination, electrocardiogram (EKG) and blood tests.

-Bone marrow and lymph node biopsies (surgical removal of a small tissue sample).

-Computed tomography (CT) and positron emission tomography (PET) scans. CT uses special x-rays to provide images of the neck, chest, abdomen and pelvis. PET uses a radioactive sugar to identify areas of disease.

During treatment (study weeks 1-12)

-Medical history and physical examinations at weeks 3, 6 and 12 to evaluate drug side effects, plus weekly telephone checks and interim visits when needed.

-Blood tests every other week to evaluate blood counts.

Evaluations after treatment (follow-up 3 months to 12 months)

-Blood tests at follow-up visits at 3, 6, 9 and 12 months after treatment to evaluate blood counts.

-Bone marrow aspiration and biopsy at 3 months after treatment to examine the effects of rituximab on bone marrow cells.

-CT scans of the neck, chest, abdomen and pelvis at 3, 6, 9 and 12 months after treatment to evaluate the response to treatment.

Sponsoring Institute:

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA

-Patients diagnosed with Chronic Lymphocytic Leukemia

-Prior therapy with fludarabine or a fludarabine containing regimen

-CD20 expression on CLL cells

-Neutrophil count ANC greater than 500/mm(3)

-Platelet count greater than 30K/mm(3)

-Age 21-99

EXCLUSION CRITERIA

-Bulky lymphadenopathy, defined as greater than 1 lymph node with greater than 5cm in largest diameter

-Evidence for transformation into high grade lymphoma (Richter's transformation)

-ECOG performance 3 or higher

-Other concurrent anticancer therapies

-Less than 3 months from last systemic therapy for CLL

-Less than 6 months from last monoclonal antibody therapy

-More than 10 doses rituximab, within 12 months preceeding protocol enrollment, either as single agent or in a combination chemotherapy regimen

-Chronic or current clinically significant infection, including HIV positivity or hepatitis C

-Moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the patient's ability to tolerate protocol therapy

-History of mucocutaneous reactions (paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis)

-Known anaphylaxis or IgE mediated hypersensitivity to murine proteins or to any component of this product

-Inability to self inject the study medication or to have it administered by a third person

-Inability to understand the investigational nature of the study ability to provide informed consent

Special Instructions:

Currently Not Provided

Keywords:

CLL

Monoclonal Antibody Therapy

Anti CD20

Biologic Response Modifier Therapy

Low Dose

Fractionated-Dose

Low-Dose

Recruitment Keyword(s):

Chronic Lymphocytic Leukemia

CLL

Condition(s):

Refractory Chronic Lymphocytic Leukemia

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

Drug: Rituximab

Supporting Site:

National Heart, Lung and Blood Institute

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Chiorazzi N, Rai KR, Ferrarini M. Chronic lymphocytic leukemia. N Engl J Med. 2005 Feb 24;352(8):804-15. Review. No abstract available.

Beum PV, Kennedy AD, Williams ME, Lindorfer MA, Taylor RP. The shaving reaction: rituximab/CD20 complexes are removed from mantle cell lymphoma and chronic lymphocytic leukemia cells by THP-1 monocytes. J Immunol. 2006 Feb 15;176(4):2600-9.

Kennedy AD, Beum PV, Solga MD, DiLillo DJ, Lindorfer MA, Hess CE, Densmore JJ, Williams ME, Taylor RP. Rituximab infusion promotes rapid complement depletion and acute CD20 loss in chronic lymphocytic leukemia. J Immunol. 2004 Mar 1;172(5):3280-8.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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