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Lenalidomide and Rituximab in Treating Patients With Non-Hodgkin Lymphoma

Primary Purpose

Lymphoma

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Rituximab

Lenalidomide

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring recurrent small lymphocytic lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

Histologically* confirmed non-Hodgkin lymphoma, including one of the following subtypes:
- Grade 1, 2, or 3a (> 15 centroblasts per high-power field with centrocytes present) follicular lymphoma according to WHO criteria
- Small lymphocytic lymphoma
NOTE: *Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies or extra-nodal biopsies; fine-needle aspirates are not acceptable for diagnosis.
At least one measurable lesion according to RECIST criteria
- Measurable lymphadenopathy to follow with serial exam and/or imaging
Relapsed or refractory disease
- Must have evidence of disease progression during or after last treatment
  - If previously treated with rituximab, must have disease progression within 6 months of last therapy OR if there was a prior response to rituximab, rituximab must not have been given within the past 6 months
No evidence of CNS metastases

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Life expectancy > 3 months
Absolute neutrophil count ≥ 1,000/mm³
Platelet count ≥ 75,000/mm³
Serum creatinine ≤ 2.0 mg/dL
Total bilirubin ≤ 2.0 mg/dL
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective double method contraception for ≥ 28 days before, during, and for ≥ 28 days after completion of study therapy
HIV negative
Able to swallow lenalidomide
Able to take aspirin (81 or 325 mg) daily or low molecular weight heparin as prophylactic anticoagulation
No neuropathy ≥ grade 2
No known active hepatitis A, B, or C
No other malignancies within the past 5 years except treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude the patient from signing the informed consent form
No condition, including the presence of laboratory abnormalities, that would preclude study participation or confound the ability to interpret study data
No known hypersensitivity to thalidomide or rituximab
No development of erythema nodosum, if characterized by a desquamating rash while taking thalidomide or similar drugs

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
At least 4 weeks since prior anticancer therapy, including radiotherapy, hormonal therapy, or surgery
More than 28 days since prior experimental drug or therapy
No prior lenalidomide
No other concurrent anticancer agents or treatments, including radiotherapy or thalidomide
No other concurrent investigational agents
No concurrent sargramostim (GM-CSF)
No other concurrent antilymphoma therapy, including steroids (except for the treatment of hypersensitivity reactions)

Sites / Locations

University of California Davis Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lenalidomide and Rituximab

Arm Description

Rituximab 375 mg/m2/wk x 4 weeks, to begin Cycle 1, Day 15. Lenalidomide 20 mg daily, days 1-21 of a 28 day cycle, to begin Day 1 of cycle 1 and continue until disease progression.

Outcomes

Primary Outcome Measures

Response, as defined by complete response (CR), near CR, partial response, or stable disease at 4 months

Responses will be assessed by the Revised Working Group Response Criteria for Malignant Lymphoma. A complete response is the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is regression of measurable disease and no new sites of disease. Stable disease is failure to attain a complete response/partial response or progressive disease.

Secondary Outcome Measures

Time to disease progression

Time to progression will be measured as the time from when the patient started treatment to the time the patient is first recorded as having disease progression, or the date of death if the patient dies due to causes other than disease progression

Tolerability (type, frequency, severity, and relationship of adverse events to study treatment as assessed by NCI CTCAE v3.0)

Duration of response

The duration of response is measured from the time measurement criteria are met for complete response/partial response(whichever status is recorded first) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The duration of response is measured from the time measurement criteria are first met for complete response until the first date that recurrent disease is objectively documented.

Overall survival

Overall survival wil be measured as the time from start of treatment to the date of death or the last date the patient was known to be alive

Full Information

NCT ID

NCT00848328

First Posted

February 19, 2009

Last Updated

August 30, 2023

Sponsor

University of California, Davis

Collaborators

Celgene

1. Study Identification

Unique Protocol Identification Number

NCT00848328

Brief Title

Lenalidomide and Rituximab in Treating Patients With Non-Hodgkin Lymphoma

Official Title

A Phase II Trial of the Combination of Lenalidomide and Rituximab in Patients With Relapsed/Refractory Follicular NHL (RV 0163)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 25, 2008 (Actual)

Primary Completion Date

April 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Davis

Collaborators

Celgene

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

RATIONALE: 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 cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving lenalidomide together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving lenalidomide together with rituximab works in treating patients with follicular or small lymphocytic non-Hodgkin lymphoma that has relapsed or not responded to treatment.

Detailed Description

OBJECTIVES: Primary To determine the response rate in patients with relapsed or refractory follicular or small lymphocytic non-Hodgkin lymphoma treated with lenalidomide and rituximab. Secondary To determine the time to disease progression, duration of response, and overall survival of these patients. To determine the tolerability of this regimen in these patients. To assess changes in serum cytokines before and after treatment and correlate these changes with response. OUTLINE: This is a multicenter study. Patients receive oral lenalidomide once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 15 and 22 of course 1 and on days 1 and 8 of course 2. Patients who do not achieve complete response after 2 courses of rituximab may receive up to 4 additional doses of rituximab once weekly for 4 weeks. Blood samples are collected at baseline and after treatment for cytokine analysis. After completion of study treatment, patients are followed at 30 days and then every 3 months thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma

Keywords

recurrent small lymphocytic lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lenalidomide and Rituximab

Arm Type

Experimental

Arm Description

Rituximab 375 mg/m2/wk x 4 weeks, to begin Cycle 1, Day 15. Lenalidomide 20 mg daily, days 1-21 of a 28 day cycle, to begin Day 1 of cycle 1 and continue until disease progression.

Intervention Type

Biological

Intervention Name(s)

Rituximab

Other Intervention Name(s)

Rituxan, MabThera

Intervention Description

Injection for Intravenous Use, 375 mg/m2/wk x 4 weeks, to begin Cycle 1, Day 15.

Intervention Type

Drug

Intervention Name(s)

Lenalidomide

Other Intervention Name(s)

REVLIMID

Intervention Description

Supplied as 5mg capsules; Dosage: 20 mg daily, days 1-21 of a 28 day cycle, to begin Day 1 of cycle 1 and continue until disease progression.

Primary Outcome Measure Information:

Title

Response, as defined by complete response (CR), near CR, partial response, or stable disease at 4 months

Description

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Time to disease progression

Description

Time Frame

Up to two years

Title

Tolerability (type, frequency, severity, and relationship of adverse events to study treatment as assessed by NCI CTCAE v3.0)

Time Frame

Up to two years

Title

Duration of response

Description

Time Frame

Up to two years

Title

Overall survival

Description

Overall survival wil be measured as the time from start of treatment to the date of death or the last date the patient was known to be alive

Time Frame

Up to two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically* confirmed non-Hodgkin lymphoma, including one of the following subtypes: Grade 1, 2, or 3a (> 15 centroblasts per high-power field with centrocytes present) follicular lymphoma according to WHO criteria Small lymphocytic lymphoma NOTE: *Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies or extra-nodal biopsies; fine-needle aspirates are not acceptable for diagnosis. At least one measurable lesion according to RECIST criteria Measurable lymphadenopathy to follow with serial exam and/or imaging Relapsed or refractory disease Must have evidence of disease progression during or after last treatment If previously treated with rituximab, must have disease progression within 6 months of last therapy OR if there was a prior response to rituximab, rituximab must not have been given within the past 6 months No evidence of CNS metastases PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy > 3 months Absolute neutrophil count ≥ 1,000/mm³ Platelet count ≥ 75,000/mm³ Serum creatinine ≤ 2.0 mg/dL Total bilirubin ≤ 2.0 mg/dL Not pregnant or nursing Negative pregnancy test Fertile patients must use effective double method contraception for ≥ 28 days before, during, and for ≥ 28 days after completion of study therapy HIV negative Able to swallow lenalidomide Able to take aspirin (81 or 325 mg) daily or low molecular weight heparin as prophylactic anticoagulation No neuropathy ≥ grade 2 No known active hepatitis A, B, or C No other malignancies within the past 5 years except treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude the patient from signing the informed consent form No condition, including the presence of laboratory abnormalities, that would preclude study participation or confound the ability to interpret study data No known hypersensitivity to thalidomide or rituximab No development of erythema nodosum, if characterized by a desquamating rash while taking thalidomide or similar drugs PRIOR CONCURRENT THERAPY: See Disease Characteristics At least 4 weeks since prior anticancer therapy, including radiotherapy, hormonal therapy, or surgery More than 28 days since prior experimental drug or therapy No prior lenalidomide No other concurrent anticancer agents or treatments, including radiotherapy or thalidomide No other concurrent investigational agents No concurrent sargramostim (GM-CSF) No other concurrent antilymphoma therapy, including steroids (except for the treatment of hypersensitivity reactions)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph M. Tuscano, MD

Organizational Affiliation

University of California, Davis

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California Davis Cancer Center

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

12. IPD Sharing Statement

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Lenalidomide and Rituximab in Treating Patients With Non-Hodgkin Lymphoma

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