Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase II Study Investigating Treatment of Post-Allogeneic Transplant Progression or Relapse of CLL/SLL/PLL or NHL With Lenalidomide Alone or With Rituximab
This phase II trial studies how well giving lenalidomide with or without rituximab works in treating patients with progressive or relapsed chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), prolymphocytic leukemia (PLL), or non-Hodgkin lymphoma (NHL). Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving lenalidomide together with or without rituximab may kill more cancer cells.
PRIMARY OBJECTIVES:
I. To improve overall survival in patients with relapse of NHL or CLL/SLL/PLL within 180 days
after allogeneic hematopoietic cell transplant (HCT).
SECONDARY OBJECTIVES:
I. Rate of response (complete response [CR], partial response [PR], or stable disease [SD])
and time to progression.
II. Grade III-IV toxicity.
III. Incidences of grades II-IV acute graft-versus-host disease (GVHD) and limited or
extensive chronic GVHD.
IV. Compare efficacy and safety between the first, second and third cohorts.
V. Laboratory research studies for efficacy and toxicity: blood samples will be stored at
baseline, day 7, and day 28 of cycle 1 and day 28 of cycle 3 to investigate:
1. changes in plasma cytokines and peripheral blood lymphocytes in correlation to treatment
with lenalidomide;
2. pharmacokinetics of rituximab;
3. donor and host polymorphisms of the FCgamma RIIIa receptor and their impact on disease
response and relapse.
OUTLINE: Patients are assigned to 1 of 2 treatment arms.
ARM I: Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1),
beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3
months of relapse, receive lenalidomide orally (PO) once daily (QD) on days 1-28 (patients
with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive
rituximab intravenously (IV) on days 1, 8, 15, and 22 of course 1 and then every two months
for courses 3, 5, 7, 9, and 11.
ARM II: Patients who have relapsed/progressed at any time point post-transplant and who have
contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive
rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.
Treatment repeats every 28 days for 12 courses in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 and 60 days and then
every 3 months for up to 18 months.
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