Neoplasms

Blood and Lymph Conditions

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Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Antibodies

Antibodies, Monoclonal

Rituximab

Immunoglobulins

Antineoplastic Agents, Immunological

Immunologic Factors

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.

Rituximab is FDA approved for the treatment of relapsed or refractory low grade or follicular CD20+ B cell non Hodgkin's lymphoma (375 mg/m(2) IV infusion once weekly for 4 or 8 doses). Recently, rituximab (anti CD20) has been introduced to CLL treatment regimens and has become an attractive choice in combination chemotherapy or as single agent treatment. Rituximab has been shown to be effective at lower doses than 375 mg/m(2) when given more frequently.

Several theoretical considerations and supporting laboratory evidence suggest that a fractionated dosing schedule using low-dose rituximab could be more effective than the current i.v. schedule of high-dose rituximab. Indeed, preliminary clinical evidence suggests that low-dose rituximab at 20mg/m2 i.v. 3-times per week can lead to steady clearance of leukemic cells without inducing substantial loss of targeted CD20.

This is a Phase I/II , single agent study which will evaluate the safety and feasibility of subcutaneous rituximab (Rituxan) administered at 20 mg/day three times a week for 12 weeks in subjects with CLL. Patients need to have had prior treatment with fludarabine, and have an elevated absolute lymphocyte count. The primary objective will be to test the safety and feasibility of giving rituximab subcutaneously. We will also obtain as a secondary endpoint an early estimate of efficacy as evidenced by (a) shrinkage of lymphadenopathy and/or (b) improvement in blood values and bone marrow biopsy findings.

Lower But More Frequent Dose Rituximab to Treat Chronic Lymphocytic Leukemia

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

National Heart, Lung, and Blood Institute (NHLBI)

Lymphoma

Lymphosarcoma

Lenalidomide

Angiogenesis Inhibitors

Growth Inhibitors

Lenalidomide regimen testing to determine efficacy for CLL/ SLL subjects

Lenalidomide (Revlimid) regimen testing to determine efficacy for SLL/ CLL subjects

Georg Aue, MD

This study will evaluate the safety and effectiveness of a new drug called lenalidomide (Revlimid) for treating patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who relapsed after their initial treatment.

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

Participants take lenalidomide capsules once a day for 21 days, followed by 21 days off the drug. This constitutes one treatment cycle. Treatment continues for four cycles as long as the medicine is tolerated. After four cycles, patients who respond completely continue treatment for another two cycles; patients who respond partially continue treatment for another four cycles; and patients who do not respond stop treatment but continue to be followed for safety.

...

There is evidence that lenalidomide has single agent activity in chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL). Optimal dosing of lenalidomide in CLL has not been established yet. A pilot clinical trial in CLL studied single agent lenalidomide cycled every 4 weeks with 25 mg for three weeks on and one week off drug. In this trial dose reductions have been necessary secondary to prolonged neutropenia or thrombocytopenia in a majority of patients. However, there was also remarkable efficacy and evidence for an immune stimulatory effect of lenalidomide. Therefore, we propose this phase II trial using 20 mg lenalidomide (Revlimid(Registered Trademark)) 3 weeks on and 3 weeks off for 4 cycles in subjects who have been previously treated for chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL). Subjects with at least partial response (PR) may go on to receive 4 additional cycles.

The primary objective of the trial is to test the efficacy of a more tolerable dosing scheme of lenalidomide.

Lenalidomide in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

A Phase II Study of Lenalidomide Revlimid(Registered Trademark) in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

To establish the overall response rate based on peripheral blood measures (absolute neutrophil count, platelets, and/or hemoglobin), lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; and bone marrow biopsy measured at 24 weeks after first dose of lenalidomide using this dosing regimen

Georg Aue, M.D.

NHLBI Hematolgy Clinician

CLL Subjects Treated With Lenalidomide (Revlimid)

To establish a response rate to lenalidomide (Revlimid) in subjects with chronic lymphocytic leukemia (CLL)/ small lymphocytic leukemia (SLL) using a 3 week on, 3 week off dosing regimen. The responses will be categorized using the revised 1996 National Cancer Institute - sponsored working guidelines. The response rate will be based on changes in peripheral blood measures (ANC, platelets and/or hemoglobin), lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; and bone marrow biopsy measured at 24 weeks after the first dose of lenalidomide using the protocol dosing regimen. Complete responders will respond to treatment after 2 cycles. Partial responders will respond to treatment after 4 cycles.

CLL Subjects Response to Lenalidomide (Revlimid)

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Georg Aue

Complete response

Partial response

No response

To establish a response rate to lenalidomide (Revlimid) in subjects with chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) using a 3 week on, 3 week off dosing regimen. Complete responders will respond to treatment after 2 cycles. Partial responders will respond to treatment after 4 cycles.

CLL Subject Response Rate After Lenalidomide Therapy

To Establish the Overall Response Rate Measured at 24 Weeks After First Dose of Lenalidomide Using This Dosing Regimen

To establish a response rate to lenalidomide (Revlimid) in subjects with CLL/SLL using a 3 week on, 3 week off dosing regimen. The responses will be categorized using the revised 1996 National Cancer Institute - sponsored working guidelines. The response rate will be based on changes in peripheral blood measures (ANC, platelets and/or hemoglobin), lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; and bone marrow biopsy measured at 24 weeks after the first dose of lenalidomide using the protocol dosing regimen. Complete responders will respond to treatment after 2 cycles. Partial responders will respond to treatment after 4 cycles.

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Lower But More Frequent Dose Rituximab to Treat Chronic Lymphocytic Leukemia	NCT00366418	Refractory Chro...	Rituximab	21 Years - 99 Years	National Institutes of Health Clinical Center (CC)
Lenalidomide in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma	NCT00439231	Chronic Lymphoc... Small Lymphocyt...	Lenalidomide	21 Years -	National Institutes of Health Clinical Center (CC)

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