Mantle Cell LymphomaPhase 1NCT02446236
Dose Finding Study of Ibrutinib Plus Lenalidomide / Rituximab in Relapsed or Refractory Mantle Cell Lymphoma
A Phase 1 study testing Lenalidomide, Ibrutinib and Rituximab in people with Mantle Cell Lymphoma, run by Hackensack Meridian Health at 1 site in United States.
Trial summary
This is a dose-escalation to determine the MTD and/or RPII for combinations of ibrutinib (PCI-32765) plus lenalidomide/rituximab in patients with relapsed/refractory mantle cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- Lenalidomide, Ibrutinib and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2015to Jan 2027
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years.
- Histologically or cytologically confirmed diagnosis of MCL.
- Relapsed or refractory MCL patients who have received at least one prior therapy are eligible. Patients who have previously received high-dose chemotherapy with peripheral stem cell support are eligible.
- Presence of at least one lymph node evaluable or mass measurable for response.
- Eastern Cooperative Oncology Group Performance Status greater than 2.
- Platelets > 75,000/μL and absolute neutrophils count (ANC) > 1,000/μL within 14 days of study registration (unless the treating physician deems the neutropenia is related to bone marrow involvement, then an ANC of > 750/mm 3 is allowed)
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- Normal renal function defined as serum creatinine less than 2.
- Recovery from any previous treatment therapy.
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test
- All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program.
- Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
- Ability to understand, and willingness to sign, a written informed consent document.
- Able to take aspirin (81 or 325 mg) daily as prophylactic anti-coagulation (patients intolerant to ASA may use low molecular weight heparin).
- Normal organ and bone marrow function parameter:
- Laboratory tests Required value WBC >3000/μL Absolute neutrophils count >1,000/μL Platelets >75,000/μL Total bilirubin < 1.5Within normal institutional limits AST (SGOT) and ALT (SGPT) <3 x institutional upper limit of normal Creatinine or creatinine clearance <1.5 within normal institutional limits >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal (calculated by Cockcroft-Gault formula)
Who cannot join
- Concomitant use of warfarin or other Vit K antagonists
- Central nervous system (CNS) involvement by lymphoma at time of enrollment.
- Other medical conditions that would potentially interfere with patient participation in this trial.
- A second malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix (unless for other tumor type patient was treated with curative intent at least 2 years previously.)
- Known human immunodeficiency virus (HIV-1) infection or chronic hepatitis B, or C (Hep B serology positive without active infection will be eligible)
- Active, clinically serious infection > CTCAE grade 2. Patients may be eligible upon resolution of the infection.
Show all 16Show fewer
- Major surgery or significant traumatic injury within 28 days of the first dose of study drug.
- Use of any other standard chemotherapy, radiation therapy, or experimental drug therapy for the treatment of MCL within 21 days of starting treatment or 5 half life times (whatever is shorter)
- Patients with grade 3/4 cardiac problems, as defined by the New York Heart Association (NYHA) criteria:
- History of uncontrolled or symptomatic angina
- History of uncontrolled arrhythmias
- Myocardial infarction < 6 months from study entry
- Uncontrolled or symptomatic congestive heart failure
- Ejection fraction below the institutional normal limit
- Any other cardiac condition that, in the opinion of the treatment physician, would make this protocol unreasonably hazardous for the patient
- Patients unwilling or unable to comply with the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
About this study
Official title: Phase Ib Dose Finding Study of Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib (PCI-32765) Plus Lenalidomide / Rituximab in Relapsed or Refractory Mantle Cell Lymphoma (MCL)
This is a dose-escalation to determine the MTD and/or RPII for combinations of ibrutinib (PCI-32765) plus lenalidomide/rituximab in patients with relapsed/refractory mantle cell lymphoma.
Read the detailed description
Mantle cell lymphoma (MCL) is a relatively rare subtype (3% to 6% (Zhou, 2008) of mature B cell non-Hodgkin lymphomas (NHL), with a median age at diagnosis in mid to late 60's, a male predominance (3/1) and typically advanced stage presentation though only about 1/3 of patients are truly symptomatic at baseline (Armitage, 1998). Although significant controversies remain in the management of MCL, all would agree that the challenges associated with MCL, particularly the poor results with standard chemotherapy and frequent chemoresistance have pushed the community to be more innovative and active in clinical research. Hence the median OS has clearly improved over the last 3 decades (from 2-3y to >5y) (Goy, 2011a), thanks to deeper responses obtained with intensive regimens in younger patients (an early CR translates into clearly better outcome) and also better salvage therapies with now MCL being the only lymphoma with 4 new biologicals approved (3 in the US and 1 in EU).
- Conditions
- Mantle Cell Lymphoma
- Being tested
- Lenalidomide, Ibrutinib, Rituximab
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Also called Revlimid
Dose escalation of lenalidomide. Patients will receive 10, 15, 20, or 25 mg PO days 1-21
IbrutinibDrug
Also called Imbruvica
560 mg PO daily
RituximabDrug
Also called Rituxan
375 mg/m2 IV Day 1
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Study | Experimental | Ibrutinib 560 mg/daily rituximab 375mg/m2 IV Day 1 Lenalidomide 10-25 mg PO days 1-21 Receives: Drug: Lenalidomide; Drug: Ibrutinib; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the MTD (Measured in mg) Based on the Number of Patients With Adverse Events
Define maximum tolerated dose (MTD) and /or recommended phase II dose for the combinations of Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib (PCI-32765) plus lenalidomide / rituximab in relapsed or refractory MCL by assessing the incidence of dose limiting toxicities (DLTs) in cycle 1 through an assessment of adverse events
Measured: 28 Days
Secondary outcomes (4)
Assess Safety Profile Through Review of Adverse Events
Assess safety and tolerability of the combinations through the review of adverse events. Patients will remain on treatment until disease progression or unacceptable toxicity. There is no predetermined length of treatment.
Measured: Through 28 Days After Discontinuation of Study Drug
Assess Radiologic Progression-Free Survival
Assess preliminary anti-tumor activity of the combinations by radiological progression-free survival. Patients will remain on treatment until disease progression or unacceptable toxicity. There is no predetermined length of treatment.
Measured: Response is evaluated after 2, 4 and 6 cycles, after initiation of treatment and later every 3 cycles until disease progression or patient taken off study
Assess Radiologic Response Rate
Assess preliminary anti-tumor activity of the combinations by radiological response rate. Patients will remain on treatment until disease progression or unacceptable toxicity. There is no predetermined length of treatment.
Measured: Response is evaluated after 2, 4 and 6 cycles, after initiation of treatment and later every 3 cycles until disease progression or patient taken off study
Assess Drug-drug Interaction of Combination Therapy
Investigate potential drug-drug interaction between Ibrutinib (PCI-32765) plus lenalidomide / rituximab. Patients will remain on treatment until disease progression or unacceptable toxicity. There is no predetermined length of treatment.
Measured: Through 28 Days After Discontinuation of Study Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study start18 Jun 2015
- Primary completion3 Jan 2017
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (55)Papers the sponsor has linked to this study.
- Other trials for Mantle Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andre Goy, MD, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02446236
- Sponsor's protocol ID
- Pro00005444
- Status last verified
- Aug 2026
- First submitted
- 6 May 2015
- Last updated
- 16 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ansell SM, Inwards DJ, Rowland KM Jr, Flynn PJ, Morton RF, Moore DF Jr, Kaufmann SH, Ghobrial I, Kurtin PJ, Maurer M, Allmer C, Witzig TE. Low-dose, single-agent temsirolimus for relapsed mantle cell lymphoma: a phase 2 trial in the North Central Cancer Treatment Group. Cancer. 2008 Aug 1;113(3):508-14. doi: 10.1002/cncr.23580.
PubMed 18543327Armitage JO. Management of mantle cell lymphoma. Oncology (Williston Park). 1998 Oct;12(10 Suppl 8):49-55.
PubMed 9830633Caballero D, Campo E, Lopez-Guillermo A, Martin A, Arranz-Saez R, Gine E, Lopez A, Gonzalez-Barca E, Canales MA, Gonzalez-Diaz M, Orfao A. Clinical practice guidelines for diagnosis, treatment, and follow-up of patients with mantle cell lymphoma. Recommendations from the GEL/TAMO Spanish Cooperative Group. Ann Hematol. 2013 Sep;92(9):1151-79. doi: 10.1007/s00277-013-1783-4. Epub 2013 May 29.
PubMed 23716187Corral LG, Kaplan G. Immunomodulation by thalidomide and thalidomide analogues. Ann Rheum Dis. 1999 Nov;58 Suppl 1(Suppl 1):I107-13. doi: 10.1136/ard.58.2008.i107. No abstract available.
PubMed 10577986Crane E, List A. Immunomodulatory drugs. Cancer Invest. 2005;23(7):625-34. doi: 10.1080/07357900500283101.
PubMed 16305990Davies F, Baz R. Lenalidomide mode of action: linking bench and clinical findings. Blood Rev. 2010 Nov;24 Suppl 1:S13-9. doi: 10.1016/S0268-960X(10)70004-7.
PubMed 21126632Dredge K, Horsfall R, Robinson SP, Zhang LH, Lu L, Tang Y, Shirley MA, Muller G, Schafer P, Stirling D, Dalgleish AG, Bartlett JB. Orally administered lenalidomide (CC-5013) is anti-angiogenic in vivo and inhibits endothelial cell migration and Akt phosphorylation in vitro. Microvasc Res. 2005 Jan;69(1-2):56-63. doi: 10.1016/j.mvr.2005.01.002.
PubMed 15797261Fisher RI, Bernstein SH, Kahl BS, Djulbegovic B, Robertson MJ, de Vos S, Epner E, Krishnan A, Leonard JP, Lonial S, Stadtmauer EA, O'Connor OA, Shi H, Boral AL, Goy A. Multicenter phase II study of bortezomib in patients with relapsed or refractory mantle cell lymphoma. J Clin Oncol. 2006 Oct 20;24(30):4867-74. doi: 10.1200/JCO.2006.07.9665. Epub 2006 Sep 25.
PubMed 17001068Geisler CH, Kolstad A, Laurell A, Andersen NS, Pedersen LB, Jerkeman M, Eriksson M, Nordstrom M, Kimby E, Boesen AM, Kuittinen O, Lauritzsen GF, Nilsson-Ehle H, Ralfkiaer E, Akerman M, Ehinger M, Sundstrom C, Langholm R, Delabie J, Karjalainen-Lindsberg ML, Brown P, Elonen E; Nordic Lymphoma Group. Long-term progression-free survival of mantle cell lymphoma after intensive front-line immunochemotherapy with in vivo-purged stem cell rescue: a nonrandomized phase 2 multicenter study by the Nordic Lymphoma Group. Blood. 2008 Oct 1;112(7):2687-93. doi: 10.1182/blood-2008-03-147025. Epub 2008 Jul 14.
PubMed 18625886Goy A, Sinha R, Williams ME, Kalayoglu Besisik S, Drach J, Ramchandren R, Zhang L, Cicero S, Fu T, Witzig TE. Single-agent lenalidomide in patients with mantle-cell lymphoma who relapsed or progressed after or were refractory to bortezomib: phase II MCL-001 (EMERGE) study. J Clin Oncol. 2013 Oct 10;31(29):3688-95. doi: 10.1200/JCO.2013.49.2835. Epub 2013 Sep 3.
PubMed 24002500Goy A, Younes A, McLaughlin P, Pro B, Romaguera JE, Hagemeister F, Fayad L, Dang NH, Samaniego F, Wang M, Broglio K, Samuels B, Gilles F, Sarris AH, Hart S, Trehu E, Schenkein D, Cabanillas F, Rodriguez AM. Phase II study of proteasome inhibitor bortezomib in relapsed or refractory B-cell non-Hodgkin's lymphoma. J Clin Oncol. 2005 Feb 1;23(4):667-75. doi: 10.1200/JCO.2005.03.108. Epub 2004 Dec 21.
PubMed 15613697Goy A, Bernstein SH, Kahl BS, Djulbegovic B, Robertson MJ, de Vos S, Epner E, Krishnan A, Leonard JP, Lonial S, Nasta S, O'Connor OA, Shi H, Boral AL, Fisher RI. Bortezomib in patients with relapsed or refractory mantle cell lymphoma: updated time-to-event analyses of the multicenter phase 2 PINNACLE study. Ann Oncol. 2009 Mar;20(3):520-5. doi: 10.1093/annonc/mdn656. Epub 2008 Dec 12.
PubMed 19074748Goy A. Are we improving the survival of patients with mantle cell lymphoma: if so, what is the explanation? Leuk Lymphoma. 2011 Oct;52(10):1828-30. doi: 10.3109/10428194.2011.604753. Epub 2011 Aug 24. No abstract available.
PubMed 21767240Goy A, Kahl B. Mantle cell lymphoma: the promise of new treatment options. Crit Rev Oncol Hematol. 2011 Oct;80(1):69-86. doi: 10.1016/j.critrevonc.2010.09.003. Epub 2010 Dec 17.
PubMed 21168343Habermann TM, Lossos IS, Justice G, Vose JM, Wiernik PH, McBride K, Wride K, Ervin-Haynes A, Takeshita K, Pietronigro D, Zeldis JB, Tuscano JM. Lenalidomide oral monotherapy produces a high response rate in patients with relapsed or refractory mantle cell lymphoma. Br J Haematol. 2009 May;145(3):344-9. doi: 10.1111/j.1365-2141.2009.07626.x. Epub 2009 Feb 24.
PubMed 19245430
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Dose Finding Study of Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib (PCI-32765) Plus Lenalidomide / Rituximab in Relapsed or Refractory Mantle Cell Lymphoma (MCL)
- ClinicalTrials.gov ID
- NCT02446236
- Acronym / sponsor ID
- Pro00005444
- Conditions
- Mantle Cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Study start
- 18 Jun 2015 (actual)
- Primary completion
- 3 Jan 2017 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 18 May 2015 (estimated)
- Results
- Posted 26 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a dose-escalation to determine the MTD and/or RPII for combinations of ibrutinib (PCI-32765) plus lenalidomide/rituximab in patients with relapsed/refractory mantle cell lymphoma.
Detailed description
Mantle cell lymphoma (MCL) is a relatively rare subtype (3% to 6% (Zhou, 2008) of mature B cell non-Hodgkin lymphomas (NHL), with a median age at diagnosis in mid to late 60's, a male predominance (3/1) and typically advanced stage presentation though only about 1/3 of patients are truly symptomatic at baseline (Armitage, 1998). Although significant controversies remain in the management of MCL, all would agree that the challenges associated with MCL, particularly the poor results with standard chemotherapy and frequent chemoresistance have pushed the community to be more innovative and active in clinical research. Hence the median OS has clearly improved over the last 3 decades (from 2-3y to >5y) (Goy, 2011a), thanks to deeper responses obtained with intensive regimens in younger patients (an early CR translates into clearly better outcome) and also better salvage therapies with now MCL being the only lymphoma with 4 new biologicals approved (3 in the US and 1 in EU).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Study | Experimental | Drug: Lenalidomide, Drug: Ibrutinib, Drug: RituximabIbrutinib 560 mg/daily rituximab 375mg/m2 IV Day 1 Lenalidomide 10-25 mg PO days 1-21 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age greater than or equal to 18 years.
- Histologically or cytologically confirmed diagnosis of MCL.
- Relapsed or refractory MCL patients who have received at least one prior therapy are eligible. Patients who have previously received high-dose chemotherapy with peripheral stem cell support are eligible.
- Presence of at least one lymph node evaluable or mass measurable for response.
- Eastern Cooperative Oncology Group Performance Status greater than 2.
Key exclusion criteria (16 listed)
- Concomitant use of warfarin or other Vit K antagonists
- Central nervous system (CNS) involvement by lymphoma at time of enrollment.
- Other medical conditions that would potentially interfere with patient participation in this trial.
- A second malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix (unless for other tumor type patient was treated with curative intent at least 2 years previously.)
- Known human immunodeficiency virus (HIV-1) infection or chronic hepatitis B, or C (Hep B serology positive without active infection will be eligible)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenalidomideAlso: RevlimidDose escalation of lenalidomide. Patients will receive 10, 15, 20, or 25 mg PO days 1-21 | Drug | Dose Escalation Study |
| IbrutinibAlso: Imbruvica560 mg PO daily | Drug | Dose Escalation Study |
| RituximabAlso: Rituxan375 mg/m2 IV Day 1 | Drug | Dose Escalation Study |
Primary outcome
Determine the MTD (Measured in mg) Based on the Number of Patients With Adverse Events
Time frame: 28 Days
Define maximum tolerated dose (MTD) and /or recommended phase II dose for the combinations of Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib (PCI-32765) plus lenalidomide / rituximab in relapsed or refractory MCL by assessing the incidence of dose limiting toxicities (DLTs) in cycle 1 through an assessment of adverse events
4 secondary outcomes
Assess Safety Profile Through Review of Adverse Events
Time frame: Through 28 Days After Discontinuation of Study Drug
Assess Radiologic Progression-Free Survival
Time frame: Response is evaluated after 2, 4 and 6 cycles, after initiation of treatment and later every 3 cycles until disease progression or patient taken off study
Assess Radiologic Response Rate
Time frame: Response is evaluated after 2, 4 and 6 cycles, after initiation of treatment and later every 3 cycles until disease progression or patient taken off study
Assess Drug-drug Interaction of Combination Therapy
Time frame: Through 28 Days After Discontinuation of Study Drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18543327Ansell SM, Inwards DJ, Rowland KM Jr, Flynn PJ, Morton RF, Moore DF Jr, Kaufmann SH, Ghobrial I, Kurtin PJ, Maurer M, Allmer C, Witzig TE. Low-dose, single-agent temsirolimus for relapsed mantle cell lymphoma: a phase 2 trial in the North Central Cancer Treatment Group. Cancer. 2008 Aug 1;113(3):508-14. doi: 10.1002/cncr.23580.
- Background: PubMed 9830633Armitage JO. Management of mantle cell lymphoma. Oncology (Williston Park). 1998 Oct;12(10 Suppl 8):49-55.
- Background: PubMed 23716187Caballero D, Campo E, Lopez-Guillermo A, Martin A, Arranz-Saez R, Gine E, Lopez A, Gonzalez-Barca E, Canales MA, Gonzalez-Diaz M, Orfao A. Clinical practice guidelines for diagnosis, treatment, and follow-up of patients with mantle cell lymphoma. Recommendations from the GEL/TAMO Spanish Cooperative Group. Ann Hematol. 2013 Sep;92(9):1151-79. doi: 10.1007/s00277-013-1783-4. Epub 2013 May 29.
- Background: PubMed 10577986Corral LG, Kaplan G. Immunomodulation by thalidomide and thalidomide analogues. Ann Rheum Dis. 1999 Nov;58 Suppl 1(Suppl 1):I107-13. doi: 10.1136/ard.58.2008.i107. No abstract available.
- Background: PubMed 16305990Crane E, List A. Immunomodulatory drugs. Cancer Invest. 2005;23(7):625-34. doi: 10.1080/07357900500283101.
- Background: PubMed 21126632Davies F, Baz R. Lenalidomide mode of action: linking bench and clinical findings. Blood Rev. 2010 Nov;24 Suppl 1:S13-9. doi: 10.1016/S0268-960X(10)70004-7.
- Background: PubMed 15797261Dredge K, Horsfall R, Robinson SP, Zhang LH, Lu L, Tang Y, Shirley MA, Muller G, Schafer P, Stirling D, Dalgleish AG, Bartlett JB. Orally administered lenalidomide (CC-5013) is anti-angiogenic in vivo and inhibits endothelial cell migration and Akt phosphorylation in vitro. Microvasc Res. 2005 Jan;69(1-2):56-63. doi: 10.1016/j.mvr.2005.01.002.
- Background: PubMed 17001068Fisher RI, Bernstein SH, Kahl BS, Djulbegovic B, Robertson MJ, de Vos S, Epner E, Krishnan A, Leonard JP, Lonial S, Stadtmauer EA, O'Connor OA, Shi H, Boral AL, Goy A. Multicenter phase II study of bortezomib in patients with relapsed or refractory mantle cell lymphoma. J Clin Oncol. 2006 Oct 20;24(30):4867-74. doi: 10.1200/JCO.2006.07.9665. Epub 2006 Sep 25.
- Background: PubMed 18625886Geisler CH, Kolstad A, Laurell A, Andersen NS, Pedersen LB, Jerkeman M, Eriksson M, Nordstrom M, Kimby E, Boesen AM, Kuittinen O, Lauritzsen GF, Nilsson-Ehle H, Ralfkiaer E, Akerman M, Ehinger M, Sundstrom C, Langholm R, Delabie J, Karjalainen-Lindsberg ML, Brown P, Elonen E; Nordic Lymphoma Group. Long-term progression-free survival of mantle cell lymphoma after intensive front-line immunochemotherapy with in vivo-purged stem cell rescue: a nonrandomized phase 2 multicenter study by the Nordic Lymphoma Group. Blood. 2008 Oct 1;112(7):2687-93. doi: 10.1182/blood-2008-03-147025. Epub 2008 Jul 14.
- Background: PubMed 24002500Goy A, Sinha R, Williams ME, Kalayoglu Besisik S, Drach J, Ramchandren R, Zhang L, Cicero S, Fu T, Witzig TE. Single-agent lenalidomide in patients with mantle-cell lymphoma who relapsed or progressed after or were refractory to bortezomib: phase II MCL-001 (EMERGE) study. J Clin Oncol. 2013 Oct 10;31(29):3688-95. doi: 10.1200/JCO.2013.49.2835. Epub 2013 Sep 3.
- Background: PubMed 15613697Goy A, Younes A, McLaughlin P, Pro B, Romaguera JE, Hagemeister F, Fayad L, Dang NH, Samaniego F, Wang M, Broglio K, Samuels B, Gilles F, Sarris AH, Hart S, Trehu E, Schenkein D, Cabanillas F, Rodriguez AM. Phase II study of proteasome inhibitor bortezomib in relapsed or refractory B-cell non-Hodgkin's lymphoma. J Clin Oncol. 2005 Feb 1;23(4):667-75. doi: 10.1200/JCO.2005.03.108. Epub 2004 Dec 21.
- Background: PubMed 19074748Goy A, Bernstein SH, Kahl BS, Djulbegovic B, Robertson MJ, de Vos S, Epner E, Krishnan A, Leonard JP, Lonial S, Nasta S, O'Connor OA, Shi H, Boral AL, Fisher RI. Bortezomib in patients with relapsed or refractory mantle cell lymphoma: updated time-to-event analyses of the multicenter phase 2 PINNACLE study. Ann Oncol. 2009 Mar;20(3):520-5. doi: 10.1093/annonc/mdn656. Epub 2008 Dec 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andre Goy, MD principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lenalidomide, Ibrutinib and Rituximab in people with Mantle Cell Lymphoma, run by Hackensack Meridian Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the MTD (Measured in mg) Based on the Number of Patients With Adverse Events (time frame: 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02446236, which also lists 55 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.