Lenalidomide With or Without Rituximab After Standard Chemotherapy in Treating Patients With Diffuse Large B-Cell Non-Hodgkin Lymphoma
A Phase II Randomized Study of Lenalidomide or Lenalidomide and Rituximab as Maintenance Therapy Following Standard Chemotherapy for Patients With High/High-intermediate Risk Diffuse Large B-Cell Lymphoma
2 other identifiers
interventional
44
1 country
4
Brief Summary
RATIONALE: Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. It may also 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. It is not yet known whether lenalidomide is more effective with or without rituximab in treating diffuse large B-cell non-Hodgkin lymphoma. PURPOSE: This randomized phase II trial is studying lenalidomide to see how well it works when given with or without rituximab after standard chemotherapy in treating patients with diffuse large B-cell non-Hodgkin lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 lymphoma
Started Oct 2008
Typical duration for phase_2 lymphoma
4 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
First Submitted
Initial submission to the registry
October 1, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedFirst Posted
Study publicly available on registry
October 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedResults Posted
Study results publicly available
April 11, 2016
CompletedApril 11, 2016
March 1, 2016
6.1 years
October 1, 2008
February 27, 2015
March 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-free Survival at 1 Year
Disease-free survival is the time from on-treatment to first relapse or death (whichever comes first). Those who are alive and without relapse are censored at the last date known alive.
From on-treatment date to disease recurrence, up to 1 year
Secondary Outcomes (2)
Disease-free Survival at 2 Years
From on-treatment date to disease recurrence, up to 2 years
Number of Patients With Each Worst-Grade Toxicity
30 days after completing treatment, for up to 13 months
Other Outcomes (2)
Investigate Potential Predictive Biomarkers of Clinical Response or Resistance to Lenalidomide
up to two years
Exploratory: Concordance Between IHC for GCB and Non-GCB Subtypes to the Gene Expression Profiles Associated With the Subtypes
up to two years
Study Arms (2)
Arm I: Lenalidomide
EXPERIMENTALArm II: Lenalidomide and Rituximab IV
EXPERIMENTALPatients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.
Interventions
Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization.
Eligibility Criteria
You may qualify if:
- Understand and voluntarily sign an Informed Consent form
- Age \> 18 years at time of signing the Informed Consent Form
- Able to adhere to the study visit schedule and other protocol requirements.
- Patients with histological confirmation of diffuse large B cell lymphoma with at least one of the following characteristics:
- High or intermediate IPI score (See Appendix 8.0 for IPI scoring criteria)
- Patients who are still PET scan positive mid therapy with R-CHOP, but, have turned negative after completion of therapy.
- Low risk International prognostic index ie., an IPI score of \<3 if age \>60 years or \<2 if age is less than or equal to 60 with c-myc positive by Fluorescent In situ Hybridization.
- No other previous lymphoma therapy, hormonal therapy or surgery, except for standard therapy with R-CHOP with or without radiation and with or without prophylactic Methotrexate therapy. Patients must be enrolled within 4-12 weeks of completion of therapy.
- At the time of study entry following standard therapy with R-CHOP±RT, patients should be in complete remission.
- ECOG performance status of ≤ 2 at study entry
- Laboratory test results within these ranges:
- Absolute neutrophil count ≥ 1500/mm³
- Platelet count ≥100K /mm³
- Serum creatinine ≤ 2.0 mg/dL
- Total bilirubin ≤ 1.5 mg/dL
- +5 more criteria
You may not qualify if:
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the Informed Consent
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- 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 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.
- Any prior use of lenalidomide.
- Concurrent use of other anti-cancer agents or treatments.
- Known positive for HIV or infectious hepatitis, type B or C.
- A diagnosis of deep vein thromboses in the preceding 3 months of study enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt-Ingram Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (4)
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295, United States
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37064, United States
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, 37064, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838, United States
Related Publications (1)
Vose JM, Habermann TM, Czuczman MS, Zinzani PL, Reeder CB, Tuscano JM, Lossos IS, Li J, Pietronigro D, Witzig TE. Single-agent lenalidomide is active in patients with relapsed or refractory aggressive non-Hodgkin lymphoma who received prior stem cell transplantation. Br J Haematol. 2013 Sep;162(5):639-47. doi: 10.1111/bjh.12449. Epub 2013 Jul 9.
PMID: 23834234DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
"Pre-specified Outcomes Measures" data were not collected as anticipated in original protocol, thus results will not be reported.
Results Point of Contact
- Title
- Dr. Nishitha Reddy
- Organization
- Vanderbilt-Ingram Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Nishitha Reddy, MD
Vanderbilt-Ingram Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine; Hematologist/Oncologist
Study Record Dates
First Submitted
October 1, 2008
First Posted
October 2, 2008
Study Start
October 1, 2008
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
April 11, 2016
Results First Posted
April 11, 2016
Record last verified: 2016-03