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
I. To improve overall survival in patients with relapse of NHL or CLL/SLL/PLL within 180
days after allogeneic hematopoietic cell transplant (HCT).
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
After completion of study treatment, patients are followed up at 30 and 60 days and then
every 3 months for up to 18 months.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Improvement in overall survival of patients receiving lenalidomide with or without rituximab in comparison to historical controls managed by single or multiple chemotherapeutic agents or donor lymphocyte infusion (DLI) (Cohort 1)
Estimated using the Kaplan-Meier method in all cohorts.
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|