CompletedNCT00695786Updated Oct 20, 2021Results posted

Lenalidomide in Combination With Rituximab in Treating Participants With Stage III/IV Indolent Non-Hodgkin Lymphoma

A Phase 2 interventional study of Lenalidomide and Rituximab in Ann Arbor Stage III Grade 1 Follicular Lymphoma, Ann Arbor Stage III Grade 2 Follicular Lymphoma and Ann Arbor Stage III Indolent Adult Non-Hodgkin Lymphoma, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-20.

Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 156
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study summary

This phase II trial studies how well lenalidomide works in combination with rituximab in treating participants with stage III-IV non-Hodgkin lymphoma that is growing slowly. Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth, which may prevent the growth of cancer cells. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving lenalidomide and rituximab may work better in participants with indolent non-Hodgkin lymphoma.

Read the detailed description

PRIMARY OBJECTIVES:

I. To evaluate the overall response rate of lenalidomide in combination with rituximab in previously untreated indolent non-Hodgkin's lymphoma (NHL).

SECONDARY OBJECTIVES:

I. To evaluate the toxicity of lenalidomide in combination with rituximab in previously untreated indolent non-Hodgkin's lymphoma.

OUTLINE: Participants are assigned to 1 of 2 drug schedules.

SCHEDULE A: Participants receive lenalidomide orally (PO) on days 1-21 and rituximab intravenously (IV) over 4-8 hours on day 1 of courses 1-12. Courses repeat every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

SCHEDULE B: Participants receive lenalidomide PO on days 2-22 and rituximab IV over 4-8 hours on days 1, 8, 15, and 22 of course 1 and on day 1 of all subsequent courses. Courses repeat every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up every 6 months.

Conditions studied

Ann Arbor Stage III Grade 1 Follicular Lymphoma
Ann Arbor Stage III Grade 2 Follicular Lymphoma
Ann Arbor Stage III Indolent Adult Non-Hodgkin Lymphoma
Ann Arbor Stage III Marginal Zone Lymphoma
Ann Arbor Stage III Small Lymphocytic Lymphoma
Ann Arbor Stage IV Grade 1 Follicular Lymphoma
Ann Arbor Stage IV Grade 2 Follicular Lymphoma
Ann Arbor Stage IV Indolent Adult Non-Hodgkin Lymphoma
Ann Arbor Stage IV Marginal Zone Lymphoma
Ann Arbor Stage IV Small Lymphocytic Lymphoma

Browse trials for

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 156 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Understand and voluntarily sign an informed consent form.
Age >/= 18 at the time of signing the informed consent form.
Able to adhere to the study visit schedule and other protocol requirements.
Untreated indolent non-Hodgkin's lymphoma stage III-IV including small lymphocytic lymphoma, marginal zone lymphoma, grade 1 or 2 follicular lymphoma. (prior radiation for localized disease allowed).
At least one measurable lesion according to the International workshop standardized response criteria for non-Hodgkin's lymphomas (IWG) greater than 1.5cm.
ECOG performance status of \</= 2 at study entry.
Laboratory test results within these ranges: Absolute neutrophil count >/= 1.5 x 10\^9/L; Platelet count >/=100 x 10\^9/L; Serum creatinine \</= 2.0 mg/dL; Total bilirubin \</=1.5 mg/dL; AST (SGOT) and ALT (SGPT) \</=2 x ULN or \</=5 x ULN if hepatic metastases are present.
Disease free of prior malignancies for >/= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast, or localized prostate cancer treated with curative intent.
All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
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 prior to and again within 24 hours of prescribing lenalidomide 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 4 weeks 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 female of child bearing potential even if they have had a successful vasectomy.
For patients with bulky disease (tumors >5cm) must be able to take aspirin (81 mg or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin.

Exclusion criteria

Exclusion Criteria:

Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Pregnant or breast feeding females.
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.
Use of any chemotherapy or experimental therapy within 28 days of enrollment.
Known hypersensitivity to thalidomide.
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Any prior use of lenalidomide.
Concurrent use of other anti-cancer agents or experimental treatments.
Known positive for HIV or infectious hepatitis type B or C. (Hepatitis B core antibody can be positive if Hep B surface antigen is negative and no HBV DNA in blood, indicating a cleared infection.)

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 156 participants (actual)

Study arms

Experimental
Schedule A (lenalidomide, rituximab)
Participants receive lenalidomide PO on days 1-21 and rituximab IV over 4-8 hours on day 1 of courses 1-12. Courses repeat every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
Drug: Lenalidomide · Biological: Rituximab
Experimental
Schedule B (lenalidomide, rituximab)
Participants receive lenalidomide PO on days 2-22 and rituximab IV over 4-8 hours on days 1, 8, 15, and 22 of course 1 and on day 1 of all subsequent courses. Courses repeat every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Drug: Lenalidomide · Biological: Rituximab

Interventions

DrugLenalidomide
Given PO
Also known as: CC-5013, CC5013, CDC 501, Revlimid
BiologicalRituximab
Given IV
Also known as: ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, CT-P10, IDEC-102, IDEC-C2B8, IDEC-C2B8 Monoclonal Antibody, MabThera, Monoclonal Antibody IDEC-C2B8, PF-05280586, Rituxan, Rituximab Biosimilar ABP 798, Rituximab Biosimilar BI 695500, Rituximab Biosimilar CT-P10, Rituximab Biosimilar GB241, Rituximab Biosimilar IBI301, Rituximab Biosimilar PF-05280586, Rituximab Biosimilar RTXM83, Rituximab Biosimilar SAIT101, RTXM83

What researchers measure

Primary outcomes

Number of Participants With Best Overall Disease Response
Will be monitored simultaneously for each of the subgroups separately using the Bayesian approach of Thall, Simon, Estey. Summary statistics will be provided for continuous variables. Frequency tables will be used to summarize categorical variables. Logistic regression will be will be utilized to assess the effect of patient prognostic factors on the response rate.
Time frame: At the end of 3 courses (84 days)

Results

Posted Sep 29, 2021

Participant flow

Recruitment period from time of protocol activation 06/10/2008 to protocol closure to new patient entry 02/04/2013.

Participant flow — Overall Study
Milestone	Other Histology	Follicular Lymphoma	Marginal Zone Lymphoma	Small Lymphocytic Lymphoma
Started	2	79	31	44
Completed	1	67	23	36
Not completed	1	12	8	8
Withdrew: Adverse event	0	3	4	2
Withdrew: Lost to follow-up	0	5	1	1
Withdrew: Withdrawal by subject	0	4	3	1
Withdrew: Deemed ineligible	1	0	0	0
Withdrew: Lack of efficacy	0	0	0	4

Outcome measures

PrimaryNumber of Participants With Best Overall Disease Response

Will be monitored simultaneously for each of the subgroups separately using the Bayesian approach of Thall, Simon, Estey. Summary statistics will be provided for continuous variables. Frequency tables will be used to summarize categorical variables. Logistic regression will be will be utilized to assess the effect of patient prognostic factors on the response rate.

Time frame:: At the end of 3 courses (84 days)
Reported as:: Count of participants · Participants

Number of Participants With Best Overall Disease Response
Participants	Other Histology	Follicular Lymphoma	Marginal Zone Lymphoma	Small Lymphocytic Lymphoma
Best Overall Response - CR	0	56	17	8
Best Overall Response - CRu Response	0	13	2	5
Best Overall Response - PR	1	6	4	21
Best Overall Response - SD	0	1	3	3
Best Overall Response - PD	0	0	1	6
Best Overall Response - Inevaluable	1	3	4	1

Adverse events

Collected over beginning at the start of intervention and through 30 days post intervention completion, up to 366 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Other Histology	0/2 (0%)	1/2 (50%)	0/2 (0%)
Follicular Lymphoma	0/79 (0%)	8/79 (10.1%)	0/79 (0%)
Marginal Zone Lymphoma	0/31 (0%)	4/31 (12.9%)	0/31 (0%)
Small Lymphocytic Lymphoma	0/44 (0%)	12/44 (27.3%)	0/44 (0%)

Most frequent serious events

Showing 10 of 14

Most frequent serious events
Event	Other Histology	Follicular Lymphoma	Marginal Zone Lymphoma	Small Lymphocytic Lymphoma
Cytokine ReleaseGeneral disorders	1/2	1/79	1/31	0/44
Secondary MalignancyNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/2	8/79	1/31	0/44
ThrombosisVascular disorders	0/2	1/79	0/31	3/44
Cardiac General (Other)Cardiac disorders	0/2	2/79	0/31	2/44
PainGeneral disorders	0/2	0/79	1/31	0/44
PneumoniaRespiratory, thoracic and mediastinal disorders	0/2	0/79	1/31	0/44
Pulmonary (Other)Respiratory, thoracic and mediastinal disorders	0/2	2/79	0/31	1/44
BronchitisRespiratory, thoracic and mediastinal disorders	0/2	0/79	0/31	1/44
DizzinessNervous system disorders	0/2	1/79	0/31	1/44
DyspneaRespiratory, thoracic and mediastinal disorders	0/2	0/79	0/31	1/44

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Other Histology	Follicular Lymphoma	Marginal Zone Lymphoma	Small Lymphocytic Lymphoma	Total
<=18 years	0	0	0	0	0
Between 18 and 65 years	1	62	24	36	123
>=65 years	1	17	7	8	33

Sex: Female, Male
Sex: Female, Male(Participants)	Other Histology	Follicular Lymphoma	Marginal Zone Lymphoma	Small Lymphocytic Lymphoma	Total
Female	0	39	18	18	75
Male	2	40	13	26	81

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Other Histology	Follicular Lymphoma	Marginal Zone Lymphoma	Small Lymphocytic Lymphoma	Total
Hispanic or Latino	0	4	6	4	14
Not Hispanic or Latino	2	54	20	30	106
Unknown or Not Reported	0	21	5	10	36

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Other Histology	Follicular Lymphoma	Marginal Zone Lymphoma	Small Lymphocytic Lymphoma	Total
American Indian or Alaska Native	0	1	0	0	1
Asian	0	1	1	0	2
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	0	0	2	4	6
White	2	72	23	35	132
More than one race	0	0	0	0	0
Unknown or Not Reported	0	5	5	5	15

Region of Enrollment
Region of Enrollment(participants)	Other Histology	Follicular Lymphoma	Marginal Zone Lymphoma	Small Lymphocytic Lymphoma	Total
United States	2	77	31	44	154
United Arab Emirates	0	2	0	0	2

Lymphoma - Non-Hodgkin Stages
Lymphoma - Non-Hodgkin Stages(Participants)	Other Histology	Follicular Lymphoma	Marginal Zone Lymphoma	Small Lymphocytic Lymphoma	Total
Stage I	0	0	1	0	1
Stage III	0	35	9	2	46
Stage IV	2	44	21	42	109

Bone Marrow Involvement (+)
Bone Marrow Involvement (+)(Participants)	Other Histology	Follicular Lymphoma	Marginal Zone Lymphoma	Small Lymphocytic Lymphoma	Total
Count of participants	2	35	9	2	48

Splenomegaly (+)
Splenomegaly (+)(Participants)	Other Histology	Follicular Lymphoma	Marginal Zone Lymphoma	Small Lymphocytic Lymphoma	Total
Count of participants	1	6	5	7	19

1 further baseline measures are reported on the registry.

Study locations

1 site

M D Anderson Cancer Center
Houston, Texas 77030, United States

References and documents

Publications

Fowler NH, Nastoupil LJ, Hagemeister FB, Neelapu SS, Fayad LE, LeBlanc D, Samaniego F, Cheah CY. Characteristics and management of rash following lenalidomide and rituximab in patients with untreated indolent non-Hodgkin lymphoma. Haematologica. 2015 Nov;100(11):e454-7. doi: 10.3324/haematol.2015.131144. Epub 2015 Aug 6. No abstract available. PubMed 26250576 ↗
Fowler NH, Davis RE, Rawal S, Nastoupil L, Hagemeister FB, McLaughlin P, Kwak LW, Romaguera JE, Fanale MA, Fayad LE, Westin JR, Shah J, Orlowski RZ, Wang M, Turturro F, Oki Y, Claret LC, Feng L, Baladandayuthapani V, Muzzafar T, Tsai KY, Samaniego F, Neelapu SS. Safety and activity of lenalidomide and rituximab in untreated indolent lymphoma: an open-label, phase 2 trial. Lancet Oncol. 2014 Nov;15(12):1311-8. doi: 10.1016/S1470-2045(14)70455-3. Epub 2014 Oct 15. PubMed 25439689 ↗

Study documents

Protocol and statistical analysis plan · Dec 5, 2011

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00695786
Lead sponsor: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Jun 12, 2008
Start date: Jun 10, 2008
Primary completion: Jul 11, 2020
Completion: Jul 11, 2020
Results posted: Sep 29, 2021
Last update: Oct 20, 2021

Study contacts

Felipe Samaniego, MD

principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Lymphoma→

Other studies from this sponsor

M.D. Anderson Cancer Center

Start the discussion