Trial Information

Summary: This is a phase II study in which patients will receive uniform doses of fludarabine and rituximab for low-grade lymphoma and chronic lymphocytic leukemia, and for responding patients who can tolerate it, CAMPATH will be given only during the final 2 months of treatment on this study.

During this study, patients will have screening tests such as bone marrow examination, CT scanning of chest and abdomen, and blood tests requiring 2 to 3 tablespoons of blood. Blood tests will include hepatitis, HSV, CSV and may include testing for HIV. State law may require that the results of positive tests be reported to a local health agency. This may be the legal obligation of the medical personnel. A CT scan is a test that produces an image of the body using a small amount of radiation. The image shows the body tissues and structure in 3-D.

Study treatment is expected to last for 6 months.

In the first four months, each cycle of study drug use will take 3 days. There will be 28 days between cycles. The fludarabine will be given by vein over a 1-hour period on a daily basis over 3 days of each cycle. On the third day of each cycle, the rituximab will be given by vein over a period of about 3 to 6 hours, depending on the dose given and how well a patient tolerates the study drugs.

Following the first 2 cycles of fludarabine and rituximab use (months 1 and 2) the doctor will re-evaluate the patient to see if whether his/her lymphoma or leukemia is responding to the study drugs. In addition to a routine physical examination, the study doctor will repeat CT scans if the scans originally showed disease in a specific area of the body.

If the re-evaluation suggests that the disease has responded to the study drugs, patients will continue to receive fludarabine and rituximab for another 2 months (months 3 and 4). Re-evaluation will occur again after the fourth month of study drug use. In the fifth and sixth months of the study, the patient will receive fludarabine for 3 consecutive days each month (months 5 and 6). Campath® will be given by injection under the skin on the 1st, 3rd and 5th day of each week for the same two months (total 8 weeks of Campath® use).

If re-evaluation shows no response to the use of fludarabine and rituximab at the conclusion of month 2, the study doctor will begin the combination of fludarabine and Campath® in month 3 rather than giving 2 additional months of combined fludarabine and rituximab. If the combined fludarabine and Campath® use does begin in month 3, patients will receive the fludarabine and Campath® over the next 3 months (months 3, 4 and 5).

Lowering of study drug dosage or delay in study drug use may be required if blood counts are too low. The study drugs will be stopped if patients develop unacceptable side effects.

If someone is unable or unwilling to receive Campath® treatments, they will receive only fludarabine and rituximab. They will be given six cycles of fludarabine and rituximab, depending on the tolerance of the drugs and the response of the disease.

Inclusion:

• Evaluation by a CPMC staff hematologist or oncologist.
• Clinical and laboratory diagnosis of low-grade stage II-IV non-Hodgkin's lymphoma (e.g., follicular lymphoma, marginal zone lymphoma, mucosa-associated lymphoid tissue lymphoma, diffuse small cell lymphoma, mantle cell lymphoma) or B-cell CLL. Immunophenotyping to confirm CD20 and CD52 positivity will be performed.
• Prior fludarabine, rituximab, or Campath therapy is not a contraindication.
• Prior radiotherapy is not a contraindication, excepting external beam irradiation to areas of active bone marrow.
• Serum creatinine < 2.5 mg/dl.
• Non-pregnant, non-lactating in pre-menopausal women.
• Each patient must be completely aware of the nature of his/her disease and must willingly consent after being informed of the procedure to be followed, alternatives, potential benefits, side-effects, risks, and discomforts. IRB approval is also required.
• No known sensitivity to murine protein.
• Seropositivity for CMV is not a contraindication.

Exclusion:

• Prior external beam irradiation to areas of active marrow.
• Serum creatinine >= 2.5 mg/dl.
• Seropositivity for hepatitis BsAg, hepatitis C, or HIV.
• Pregnancy, lactation.

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Trial listings updated: June 1, 2008 at 5:44:18 AM