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LymphomaPhase 2NCT00848328

Lenalidomide and Rituximab in Treating Patients With Non-Hodgkin Lymphoma

A Phase 2 study testing Rituximab and Lenalidomide in people with Lymphoma, run by University of California, Davis at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
Rituximab and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
25 Aug 2008to 15 Apr 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California Davis Cancer Center

    Sacramento, California, 95817

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Lymphoma
Being tested
Rituximab, Lenalidomide
Keywords
recurrent small lymphocytic lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma
Medical subject headings
Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabBiological

    Also called Rituxan, MabThera

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

  • LenalidomideDrug

    Also called REVLIMID

    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.

Study groups in NCT00848328
Study groupRoleWhat they receive
Lenalidomide and RituximabExperimentalRituximab 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.
Receives: Biological: Rituximab; Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 months

Secondary outcomes (4)

  1. 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

    Measured: Up to two years

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

    Measured: Up to two years

  3. 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.

    Measured: Up to two years

  4. 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

    Measured: Up to two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2009 (estimated)
  2. Study start25 Aug 2008
  3. Primary completion28 Jun 2023
  4. Study completion15 Apr 2024

Why it stopped: Poor accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00848328
Sponsor's protocol ID
220942
Other IDs
CDR0000634775, CELGENE-RV-PI-NHL-0163, UCD-197
Status last verified
Apr 2025
First submitted
19 Feb 2009
Last updated
24 Apr 2025
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab and Lenalidomide in people with Lymphoma, run by University of California, Davis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Poor accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response, as defined by complete response (CR), near CR, partial response, or stable disease at 4 months (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00848328.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.

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