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NCT01419795 · REGISTRY CONDITION SEARCH

Lenalidomide With or Without Rituximab in Treating Patients With Progressive or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia, or Non-Hodgkin Lymphoma Previously Treated With Donor Stem Cell Transplant

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2017-07-27

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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)

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outcome · POSTED

Rate of Response (CR, PR, or SD) and Time to Progression

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outcome · POSTED

Grade III-IV Toxicity in Patients Receiving Lenalidomide With or Without Rituximab

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outcome · POSTED

Incidences of Grades II-IV Acute GVHD and Limited or Extensive Chronic GVHD

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outcome · POSTED

Comparison of Rates of Overall Response and Complete Remission Between the First, Second, and Third Cohorts

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outcome · POSTED

Changes in Plasma Cytokines and Peripheral Blood Lymphocytes in Correlation to Treatment With Lenalidomide

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outcome · POSTED

Comparison of Incidences of Adverse Events Between the First, Second, and Third Cohorts

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outcome · POSTED

Pharmacokinetics of Rituximab: Evaluation of Serum Concentrations and Correlations to Drug Dose and Clinical Responses

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outcome · POSTED

Donor and Host Polymorphisms of the FCgamma RIIIa Receptor and Their Impact on Disease Response and Relapse

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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)
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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 PO 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 IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.
    intervention Names
    1. Drug: lenalidomide
    2. Biological: rituximab
    3. Other: pharmacological study
    4. Other: laboratory biomarker analysis
    label
    Arm I (lenalidomide, rituximab)
    type
    EXPERIMENTAL
  2. description
    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.
    intervention Names
    1. Drug: lenalidomide
    2. Other: pharmacological study
    3. Other: laboratory biomarker analysis
    label
    Arm II (lenalidomide)
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Arm I (lenalidomide, rituximab)
    2. Arm II (lenalidomide)
    description
    Given PO
    name
    lenalidomide
    other Names
    1. CC-5013
    2. IMiD-1
    3. Revlimid
    type
    DRUG
  2. arm Group Labels
    1. Arm I (lenalidomide, rituximab)
    description
    Given IV
    name
    rituximab
    other Names
    1. IDEC-C2B8
    2. IDEC-C2B8 monoclonal antibody
    3. Mabthera
    4. MOAB IDEC-C2B8
    5. Rituxan
    type
    BIOLOGICAL
  3. arm Group Labels
    1. Arm I (lenalidomide, rituximab)
    2. Arm II (lenalidomide)
    description
    Correlative studies
    name
    pharmacological study
    other Names
    1. pharmacological studies
    type
    OTHER
  4. arm Group Labels
    1. Arm I (lenalidomide, rituximab)
    2. Arm II (lenalidomide)
    description
    Correlative studies
    name
    laboratory biomarker analysis
    type
    OTHER
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
3
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Estimated using the Kaplan-Meier method in all cohorts.
    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)
    time Frame
    12 months
secondary Outcomes
  1. description
    Estimated using the Kaplan-Meier method in all cohorts. Assessed at day 100.
    measure
    Rate of Response (CR, PR, or SD) and Time to Progression
    time Frame
    Assessed up to 18 months
  2. measure
    Grade III-IV Toxicity in Patients Receiving Lenalidomide With or Without Rituximab
    time Frame
    Assessed up to 30 days after completion of study treatment
  3. measure
    Incidences of Grades II-IV Acute GVHD and Limited or Extensive Chronic GVHD
    time Frame
    Assessed up to 30 days after completion of study treatment
  4. measure
    Comparison of Rates of Overall Response and Complete Remission Between the First, Second, and Third Cohorts
    time Frame
    Assessed up to 18 months
  5. measure
    Changes in Plasma Cytokines and Peripheral Blood Lymphocytes in Correlation to Treatment With Lenalidomide
    time Frame
    From baseline to day 28 of course 3
  6. measure
    Comparison of Incidences of Adverse Events Between the First, Second, and Third Cohorts
    time Frame
    Assessed up to 30 days after completion of study treatment
  7. measure
    Pharmacokinetics of Rituximab: Evaluation of Serum Concentrations and Correlations to Drug Dose and Clinical Responses
    time Frame
    Baseline, day 7 and 28 of course 1, and day 28 of course 3
  8. measure
    Donor and Host Polymorphisms of the FCgamma RIIIa Receptor and Their Impact on Disease Response and Relapse
    time Frame
    Baseline, day 7 and 28 of course 1, and day 28 of course 3
Full study description
brief Summary
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.
detailed Description
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.
Source references
Source notices and limitations
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    Preserved source evidence · Not medical advice