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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

Phase 2
18 Years
Open (Enrolling)
Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Cutaneous B-cell Non-Hodgkin Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Hepatosplenic T-cell Lymphoma, Intraocular Lymphoma, Nodal Marginal Zone B-cell Lymphoma, Noncutaneous Extranodal Lymphoma, Peripheral T-cell Lymphoma, Prolymphocytic Leukemia, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Hairy Cell Leukemia, Small Intestine Lymphoma, Splenic Marginal Zone Lymphoma, T-cell Large Granular Lymphocyte Leukemia, Testicular Lymphoma, Waldenström Macroglobulinemia

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Trial Information

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
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.

Inclusion Criteria:

- Understand and voluntarily sign an informed consent form

- Able to adhere to the study visit schedule and other protocol requirements

- Patients with CLL/SLL/PLL or NHL and who:

- Met the criteria of relapse or progression after allogeneic HCT according to the
HCT protocol or the attending discretion and who,

- Not responding to appropriate tapering of immunosuppressive medications

- Absolute neutrophil count (ANC) >= 1500/mm^3 or >= 1000/mm^3 if ANC has persistently
< 1500/ mm^3 for more than 2 weeks

- Platelet count (transfusion independent) >= 50,000/mm^3 or >= 20,000/mm^3 if platelet
count has persistently < 50,000/mm^3 for more than 2 weeks

- Creatinine clearance >= 30ml/min by Cockcroft-Gault formula

- Total bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN if total bilirubin
has been persistently > 1.5 x ULN for more than 2 weeks

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and
alanine transaminase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3 x ULN or
=< 5 x ULN if AST or ALT have been persistently > 3 x ULN for more than 2 weeks

- Females of childbearing potential (FCBP) must have a negative serum or urine
pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again
within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be
filled within 7 days) and must either commit to continued abstinence from
heterosexual intercourse or begin TWO acceptable methods of birth control, one highly
effective method and one additional effective method AT THE SAME TIME, at least 28
days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy
testing; men must agree to use a latex condom during sexual contact with a FCBP even
if they have had a successful vasectomy

- All study participants must be registered into the mandatory RevAssist program, and
be willing and able to comply with the requirements of RevAssist

- Study participants with risk factors for venous thrombo-embolism (VTE), such as
previous VTE, cardiac disease, chronic renal insufficiency, and/or poorly controlled
diabetes, should be able to comply with some degree of prophylactic anticoagulation
using aspirin 81 or 325 mg daily, coumadin, or low molecular weight heparin

Exclusion Criteria:

- Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the patient from signing the informed consent form

- Pregnant or breast feeding females; (lactating females must agree not to breast feed
while taking lenalidomide)

- Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study

- Known hypersensitivity to thalidomide

- The development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs

- Resistance to prior use of lenalidomide, defined as progression on full dose
lenalidomide within the first two cycles of therapy

- Concurrent use of other anti-cancer agents or treatments

- Known seropositive for or active viral infection with human immunodeficiency virus

- Karnofsky performance status < 50%

- Active grades III or IV acute graft-versus-host disease (GVHD)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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)

Outcome Description:

Estimated using the Kaplan-Meier method in all cohorts.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Mohamed Sorror

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium


United States: Federal Government

Study ID:




Start Date:

May 2012

Completion Date:

Related Keywords:

  • Adult Nasal Type Extranodal NK/T-cell Lymphoma
  • Anaplastic Large Cell Lymphoma
  • Angioimmunoblastic T-cell Lymphoma
  • Cutaneous B-cell Non-Hodgkin Lymphoma
  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Hepatosplenic T-cell Lymphoma
  • Intraocular Lymphoma
  • Nodal Marginal Zone B-cell Lymphoma
  • Noncutaneous Extranodal Lymphoma
  • Peripheral T-cell Lymphoma
  • Prolymphocytic Leukemia
  • Recurrent Adult Burkitt Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Diffuse Mixed Cell Lymphoma
  • Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
  • Recurrent Adult Grade III Lymphomatoid Granulomatosis
  • Recurrent Adult Immunoblastic Large Cell Lymphoma
  • Recurrent Adult Lymphoblastic Lymphoma
  • Recurrent Adult T-cell Leukemia/Lymphoma
  • Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Mycosis Fungoides/Sezary Syndrome
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Hairy Cell Leukemia
  • Small Intestine Lymphoma
  • Splenic Marginal Zone Lymphoma
  • T-cell Large Granular Lymphocyte Leukemia
  • Testicular Lymphoma
  • Waldenström Macroglobulinemia
  • Burkitt Lymphoma
  • Immunoblastic Lymphadenopathy
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Hairy Cell
  • Leukemia, Lymphoid
  • Leukemia, Prolymphocytic
  • Leukemia, T-Cell
  • Leukemia-Lymphoma, Adult T-Cell
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphomatoid Granulomatosis
  • Waldenstrom Macroglobulinemia
  • Mycoses
  • Mycosis Fungoides
  • Sezary Syndrome
  • Lymphoma, B-Cell
  • Lymphoma, Large-Cell, Immunoblastic
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous
  • Lymphoma, T-Cell, Peripheral
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Extranodal NK-T-Cell
  • Lymphoma, Mantle-Cell
  • Leukemia, Large Granular Lymphocytic



Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle, Washington  98109