Could a new drug combo boost transplant success in lymphoma?
NCT ID NCT01241734
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested adding lenalidomide (Revlimid) to standard chemotherapy (RICE) for people with relapsed diffuse large B-cell lymphoma. The goal was to see if the combination is safe and can improve response rates, helping more patients qualify for a stem cell transplant. Only 18 people took part, and the results are early and limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lenalidomide (Revlimid) combined with rituximab, ifosfamide, etoposide, and carboplatin (RICE chemotherapy)
- What this could lead to
- If this combination works well, it could help more patients with relapsed DLBCL achieve remission and successfully undergo a stem cell transplant, potentially improving long-term survival.
- What could go wrong
- This is a small, early-phase trial (18 participants) testing safety and dosing, not a proven treatment. The added lenalidomide may increase side effects, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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18 people
The number who actually took part.
- Started
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Oct 2010
- Finished
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Sep 2015
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria:Understand and voluntarily sign an informed consent form. 1. Age 18 years at the time of signing the informed consent form. 2. Able to adhere to the study visit schedule and other protocol requirements. 3. Histologically confirmed diffuse large B cell lymphoma 4. 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. 5. 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 6. Histologically confirmed involvement of the bone marrow by DLBCL on the bone marrow biopsy without other measurable disease 7. Eligible for autologous stem cell transplant 8. All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least two weeks prior to treatment in this study. 9. Eastern Cooperative Oncology Group (ECOG) performance status of 2 at study entry (see Appendix B). 10. Laboratory test results within these ranges: * Absolute neutrophil count \>1000 /mm³ * Platelet count \> 50,000/mm³ (unless bone marrow is heavily infiltrated with underlying disease (50% or more) Calculated creatinine clearance of ≥ 60 mL/min by Cockroft-Gault formula (Appendix E) for patients enrolled into the phase I portion of the study (Stage I). Calculated creatinine clearance of ≥ 30 mL/min by Cockroft-Gault formula for patients enrolled into the phase II portion of the study (Stage II). See Section 5.4.2 for lenalidomide dose adjustment for calculated creatinine clearance \> 30ml/min and \< 60ml/min. * Total bilirubin \< 1.5 x Upper Limit of Normal (ULN). * Aspartate Aminotransferase (SGOT) and Alanine Aminotransferase (SGPT) \< 3 x ULN. 11. 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. 12. All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®. 13. Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-International unit (mIU)/mL within 10 - 14 days prior to and again within 24 hours of starting 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 28 days 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 FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. See Appendix A: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods. 14. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid (ASA) may use warfarin or low molecular weight heparin). \- Exclusion Criteria: Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. 1. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide). 2. 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. 3. Evidence of laboratory tumor lysis syndrome (TLS) by Cairo-Bishop Definition of Tumor Lysis Syndrome. Subjects may be enrolled upon correction of electrolyte abnormalities. 4. Use of any other experimental drug or therapy within 28 days of baseline. 5. Known hypersensitivity to thalidomide. 6. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs. 7. Concurrent use of other nonprotocol anti-cancer agents or treatments. 8. Known positive for HIV or active infectious hepatitis, type B or C. 9. Refusal of autologous stem cell transplant. 10. Patients with active central nervous system involvement based on clinical evaluation. Previously treated central nervous system (CNS) involvement that has remained asymptomatic for more than ninety days is allowed if no active CNS disease present as confirmed by MRI or/and lumbar puncture. 11. Concurrent uncontrolled serious medical ort psychiatric conditions likely to interfere with participation in this clinical study, as judged by investigator. 12. Prior Lenalidomide exposure for more than 28 days. \-
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Duke University Medical Center
Durham, North Carolina, 27710, United States
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John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
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