Study of Lenalidomide in Combination With RICE With Lenalidomide Maintenance Post-Auto Transplant… (NCT01241734) | Clinical Trial Compass
CompletedPhase 1/2
Study of Lenalidomide in Combination With RICE With Lenalidomide Maintenance Post-Auto Transplant for DLBCL
United States18 participantsStarted 2010-10
Plain-language summary
The standard of care therapy for DLBCL in the relapsed setting is RICE with the plan for the patient to proceed to transplant. This protocol will add Revlimid to the first 7 days of the RICE therapy and again after transplant as maintenance. To improve over all outcome and survival.
Hypothesis is that combining lenalidomide with standard of care (RICE) may increase overall response rate thus increasing the number of patients able to proceed with autologous stem cell transplant. This in turn may translate into improved overall survival and progression free survival.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18 years at the time of signing the informed consent form.
. Able to adhere to the study visit schedule and other protocol requirements.
. Histologically confirmed diffuse large B cell lymphoma
. Relapsed or refractory after one prior therapeutic treatment for DLBCL. Refractory is defined as patients received adequate prior treatment and did not respond during treatment or progressed within 90 days of last treatment.
. Measurable disease with at least on bidimensional lymph node or tumor mass \>1.5 cm in the longest diameter that can be followed for response as a target lesion as measured by PET or CT
. Histologically confirmed involvement of the bone marrow by DLBCL on the bone marrow biopsy without other measurable disease
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Stage I - Safety (Type, Frequency, Severity and Relationship of Adverse Events to Study Treatment) and Tolerability
Timeframe: Cycle 1 of Treatment (28 Days)
2
Stage II - Overall Response Rate
Timeframe: After 2 Cycles of Treatment (28 Day Cycles)
3
Stage III - Overall Response Rate
Timeframe: After 2 Cycles of Treatment (28 Day Cycles)
. All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least two weeks prior to treatment in this study.
Exclusion criteria
. 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.
. Evidence of laboratory tumor lysis syndrome (TLS) by Cairo-Bishop Definition of Tumor Lysis Syndrome. Subjects may be enrolled upon correction of electrolyte abnormalities.
. 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.
. Concurrent use of other nonprotocol anti-cancer agents or treatments.
. Known positive for HIV or active infectious hepatitis, type B or C.