Study Stopped
Extreme toxicity in Phase I, study did not proceed to Phase II
Lenalidomide And Rituximab as Maintenance Therapy in Treating Patients With B-Cell Non-Hodgkin Lymphoma
Phase I/II Trial of Maintenance Therapy With Lenalidomide and Rituximab Following High-Dose Chemotherapy and Autologous Stem Cell Transplantation for B-cell Non-Hodgkin Lymphoma
2 other identifiers
interventional
5
1 country
3
Brief Summary
RATIONALE: Lenalidomide may stop the growth of cancer by blocking blood flow to the tumor. 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 be an effective treatment for B-cell non-Hodgkin lymphoma. PURPOSE: This phase I/II trial is studying the side effects and best dose of lenalidomide when given together with rituximab as maintenance therapy in treating patients with B-cell non-Hodgkin lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2010
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 8, 2010
CompletedFirst Posted
Study publicly available on registry
January 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedNovember 26, 2015
November 1, 2015
1.2 years
January 8, 2010
November 25, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Maximum tolerated dose of lenalidomide (Phase I)
24 months
Proportion of subjects who are able to complete 12 cycles of maintenance therapy with lenalidomide and rituximab after autologous stem cell transplantation (ASCT)(PHASE II)
1 year
Secondary Outcomes (7)
Progression-free survival after ASCT
24 months
Evaluation of potential differences in effects of lenalidomide and rituximab on progression-free survival after ASCT according to histologic subtypes of B-cell NHL
24 months
Overall response rate associated with treatment with lenalidomide and rituximab after ASCT, defined as the proportion of subjects with measurable disease at enrollment who achieve a partial response or complete response
6-12 months
Enumeration of peripheral blood lymphocyte subsets by flow cytometry, including T cells, B cells, and NK cells and analysis of potential associations between these levels with progression-free survival
At study entry, 1 month, and 1 year
Analysis of FCgammaRIIIa receptor sequences in enrolled subjects to determine the presence or absence of FCgammaRIIIa-158 polymorphisms (V/V, V/F, and F/F); determining potential associations of these polymorphisms with progression-free survival
12 months
- +2 more secondary outcomes
Study Arms (1)
Arm I
EXPERIMENTALPatients receive oral lenalidomide once daily on days 1-21 and rituximab IV on day 1of courses 1, 3, 5, 7, 9, and 11.
Interventions
Given IV
Correlative study
Eligibility Criteria
You may qualify if:
- Understand and voluntarily sign an informed consent form
- Able to adhere to the study visit schedule and other protocol requirements
- Histologic diagnosis of CD20+ B-cell NHL including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and other B-cell lymphomas excluding chronic lymphocytic leukemia
- Received high-dose chemotherapy with autologous stem cell transplantation (ASCT) from 42 to 128 days before enrollment with stable disease, partial response or complete response following ASCT
- All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study
- ECOG performance status of =\< 2 at study entry; Karnofsky performance status of \>= 70% at study entry
- Absolute neutrophil count \>= 1,500/mm\^3
- Platelet count \>= 75,000/mm\^3
- Serum creatinine =\< 2.0 mg/dL
- Phase I subjects must have estimated or measured creatinine clearance \>= 60 ml/min
- Phase II subjects must have estimated or measured creatinine clearance \>= 30 ml/min
- 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
- 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 for cycle 1 (prescriptions must be filled within 7 days)
- +5 more criteria
You may not qualify if:
- Any serious medical condition, laboratory abnormality, or psychiatric illness that in the opinion of the investigator would prevent the subject from providing written informed consent
- Pregnant or breast feeding females (lactating females must agree not to breast feed while taking lenalidomide)
- Use of any other experimental drug or therapy within 28 days of baseline
- Known hypersensitivity to thalidomide
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
- Known hypersensitivity to rituximab
- Concurrent use of other anti-cancer agents or treatments
- Known positive for HIV or infectious hepatitis, type B or C
- Residual grade 3 or grade 4 non-hematologic toxicity after ASCT
- Transfusion requirement (red blood cells or platelets) within 14 days prior to baseline
- Use of hematopoietic growth factor (including filgrastim, pegfilgrastim, sargramostim, erythropoietin, or darbepoetin) within 14 days prior to baseline
- Any other condition not defined above, including the presence of laboratory abnormalities, which in the opinion of the investigator would place the subject at unacceptable risk if he/she were to participate in the study, or would confound the ability to interpret data from the study
- Prior use of lenalidomide either concurrently with rituximab or within 8 weeks following a dose of rituximab
- Concomitant use of other anti-cancer therapies, including radiation, thalidomide, or other investigational agents is not permitted while subjects are receiving protocol therapy during the treatment phase of the study
- Corticosteroid therapy also is not permitted while subjects are receiving protocol therapy during the treatment phase of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Fairview Cancer Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Dean, MD
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2010
First Posted
January 11, 2010
Study Start
January 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2012
Last Updated
November 26, 2015
Record last verified: 2015-11