Dose Finding Study of Ibrutinib Plus Lenalidomide / Rituximab in Relapsed or Refractory Mantle Ce… (NCT02446236) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Dose Finding Study of Ibrutinib Plus Lenalidomide / Rituximab in Relapsed or Refractory Mantle Cell Lymphoma
United States27 participantsStarted 2015-06-18
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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)
* 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 parame…
What they're measuring
1
Determine the MTD (Measured in mg) Based on the Number of Patients With Adverse Events