A Phase 2 interventional study of rituximab and lenalidomide in Lymphoma, sponsored by Alliance for Clinical Trials in Oncology. Completed at 79 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-15.
Sponsored by Alliance for Clinical Trials in Oncology · Phase 2, Interventional, and Treatment
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. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide may also stop the growth of non-Hodgkin's lymphoma by blocking blood flow to the cancer. Giving rituximab together with lenalidomide may kill more cancer cells. This randomized phase II trial is studying how well rituximab and/or lenalidomide work in treating patients with follicular non-Hodgkin's lymphoma that is not refractory to rituximab.
Outline:
This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms. Please see the "Arms" section for a description of each treatment arm. The primary and secondary objectives of the study are provided below.
Primary Objectives:
Secondary Objectives:
After completion of study treatment, patients are followed for up to 10 years from study entry.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 97 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Documentation of Disease
Prior Treatment
Measurable disease must be present either on physical examination or imaging studies. Non-measurable disease alone is not acceptable. Any tumor mass >1 cm is acceptable.Lesions that are considered non-measurable include the following:
Required Initial Laboratory Values:
Patients receive rituximab IV on days 1, 8, 15, and 22.
Biological: rituximab
Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Drug: lenalidomide
Patients receive lenalidomide as in arm II. Patients also receive rituximab IV on days 8, 15, 22 and 29.
Biological: rituximab · Drug: lenalidomide
Given IV
Given orally
Overall Response Rate
Response is assessed by investigator according to International Working Group (IWG) criteria. A complete response requires disappearance of all evidence of disease. A partial response is a \>/= 50% decrease in the sum of products of 6 largest dominant nodes or nodal masses as well as for splenic and hepatic nodules. No increase in size of nodes, liver or spleen and no new sites of disease.
Time frame: Duration of treatment (12 cycles)
Time to Progression
Time to progression (TTP) is defined as the time from study entry until progression or death without progression. The median TTP with 95% CI was estimated using the Kaplan-Meier method.
Time frame: Up to 10 years
Between October 2006 and April 2011, 97 participants were accrued to the study.
| Milestone | Arm I - Rituximab | Arm II - Lenalidomide | Arm III - Lenalidomide and Rituximab |
|---|---|---|---|
| Started | 3 | 48 | 46 |
| Completed | 3 | 45 | 46 |
| Not completed | 0 | 3 | 0 |
| Withdrew: Withdrawal by subject | 0 | 3 | 0 |
Response is assessed by investigator according to International Working Group (IWG) criteria. A complete response requires disappearance of all evidence of disease. A partial response is a \>/= 50% decrease in the sum of products of 6 largest dominant nodes or nodal masses as well as for splenic and hepatic nodules. No increase in size of nodes, liver or spleen and no new sites of disease.
| percentage of participants | Arm I - Rituximab | Arm II - Lenalidomide | Arm III - Lenalidomide and Rituximab |
|---|---|---|---|
| Overall Response Rate | — | 53.3 (37.9 to 68.3) | 76.1 (61.2 to 87.4) |
Time to progression (TTP) is defined as the time from study entry until progression or death without progression. The median TTP with 95% CI was estimated using the Kaplan-Meier method.
| years | Arm I - Rituximab | Arm II - Lenalidomide | Arm III - Lenalidomide and Rituximab |
|---|---|---|---|
| Time to Progression | — | 1.1 (0.8 to 1.2) | 2 (1.7 to 3.0) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I - Rituximab | — | — | — |
| Arm II - Lenalidomide | — | 8/45 (17.8%) | 44/45 (97.8%) |
| Arm III - Lenalidomide and Rituximab | — | 12/45 (26.7%) | 41/45 (91.1%) |
| Event | Arm I - Rituximab | Arm II - Lenalidomide | Arm III - Lenalidomide and Rituximab |
|---|---|---|---|
| FatigueGeneral disorders | — | 5/45 | 7/45 |
| Platelet count decreasedInvestigations | — | 6/45 | 5/45 |
| Blood glucose increasedMetabolism and nutrition disorders | — | 4/45 | 6/45 |
| Leukocyte count decreasedInvestigations | — | 4/45 | 5/45 |
| Serum albumin decreasedMetabolism and nutrition disorders | — | 0/45 | 5/45 |
| Serum sodium decreasedMetabolism and nutrition disorders | — | 1/45 | 5/45 |
| Hemoglobin decreasedBlood and lymphatic system disorders | — | 4/45 | 4/45 |
| ConstipationGastrointestinal disorders | — | 1/45 | 4/45 |
| Neutrophil count decreasedInvestigations | — | 2/45 | 4/45 |
| Serum calcium decreasedMetabolism and nutrition disorders | — | 2/45 | 4/45 |
| Event | Arm I - Rituximab | Arm II - Lenalidomide | Arm III - Lenalidomide and Rituximab |
|---|---|---|---|
| FatigueGeneral disorders | — | 35/45 | 33/45 |
| Neutrophil count decreasedInvestigations | — | 19/45 | 25/45 |
| Platelet count decreasedInvestigations | — | 25/45 | 23/45 |
| ConstipationGastrointestinal disorders | — | 21/45 | 16/45 |
| Leukocyte count decreasedInvestigations | — | 21/45 | 16/45 |
| Hemoglobin decreasedBlood and lymphatic system disorders | — | 19/45 | 17/45 |
| Peripheral sensory neuropathyNervous system disorders | — | 15/45 | 17/45 |
| NauseaGastrointestinal disorders | — | 16/45 | 12/45 |
| Blood glucose increasedMetabolism and nutrition disorders | — | 15/45 | 14/45 |
| DiarrheaGastrointestinal disorders | — | 14/45 | 14/45 |
Three participants assigned to the lenalidomide arm alone arm never began treatment. Participants on the rituximab arm was discontinued early; in order to avoid potential identification of patients, no results will be entered for this arm.
| Age, Continuous(years) | Arm I - Rituximab | Arm II - Lenalidomide | Arm III - Lenalidomide and Rituximab | Total |
|---|---|---|---|---|
| Median | — | 63 (34 to 85) | 64 (36 to 89) | 63 (34 to 89) |
| Sex: Female, Male(Participants) | Arm I - Rituximab | Arm II - Lenalidomide | Arm III - Lenalidomide and Rituximab | Total |
|---|---|---|---|---|
| Female | — | 18 | 19 | 37 |
| Male | — | 27 | 27 | 54 |
| Race (NIH/OMB)(Participants) | Arm I - Rituximab | Arm II - Lenalidomide | Arm III - Lenalidomide and Rituximab | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | — | 0 | 0 | 0 |
| Asian | — | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | — | 1 | 0 | 1 |
| Black or African American | — | 3 | 1 | 4 |
| White | — | 37 | 44 | 81 |
| More than one race | — | 0 | 0 | 0 |
| Unknown or Not Reported | — | 4 | 0 | 4 |
| Region of Enrollment(participants) | Arm I - Rituximab | Arm II - Lenalidomide | Arm III - Lenalidomide and Rituximab | Total |
|---|---|---|---|---|
| United States | — | 45 | 46 | 91 |
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions 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.
Alliance for Clinical Trials in Oncology