Ibrutinib and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT02219737|
Recruitment Status : Completed
First Posted : August 19, 2014
Last Update Posted : January 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|CD20 Positive Recurrent Diffuse Large B-Cell Lymphoma Refractory Diffuse Large B-Cell Lymphoma||Drug: Carboplatin Drug: Etoposide Drug: Ibrutinib Drug: Ifosfamide Other: Laboratory Biomarker Analysis Other: Pharmacological Study Biological: Rituximab||Phase 1|
I. Safety of ibrutinib in combination with rituximab-ifosfamide, carboplatin, and etoposide (R-ICE).
II. Establishment of maximum tolerated dose of ibrutinib with R-ICE.
I. Pharmacokinetic (PK) studies of ibrutinib in combination with R-ICE. II. Clinical response rate of ibrutinib+R-ICE.
OUTLINE: This is a dose-escalation study of ibrutinib.
Patients receive ibrutinib orally (PO) once daily (QD) on days 1-21, rituximab intravenously (IV) on day 1, ifosfamide IV on day 3, carboplatin intravenously piggy back (IVPB) on day 3, and etoposide IVPB on days 2-4. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 52 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study Combining Ibrutinib With Rituximab, Ifosfamide, Carboplatin, and Etoposide (R-ICE) in Patients With Relapsed or Primary Refractory Diffuse Large B-Cell Lymphoma (DLBCL)|
|Actual Study Start Date :||September 12, 2014|
|Actual Primary Completion Date :||May 11, 2017|
|Actual Study Completion Date :||May 11, 2017|
Experimental: Treatment (ibrutinib, R-ICE)
Patients receive ibrutinib PO QD on days 1-21, rituximab IV on day 1, ifosfamide IV on day 3, carboplatin IVPB on day 3, and etoposide IVPB on days 2-4. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
- Maximum tolerated dose of the combination of ibrutinib with standard dosing R-ICE, graded using the Common Terminology Criteria for Adverse Events 4.0 [ Time Frame: Day 21 ]
- Toxicity of the combination of ibrutinib with standard dosing R-ICE, graded using the CTCAE 4.0 [ Time Frame: Up to week 52 ]
- Overall response rate, defined as the sum of partial and complete responses as determined by revised International Working Group Criteria for Malignant Lymphoma [ Time Frame: Up to week 52 ]The proportion of patients who achieve a clinical response (partial response or better) will be estimated in this patient population. This will be calculated among patients who receive any study drug, and additionally among patients who complete three cycles of therapy.
- PK parameters of ibrutinib in the presence of R-ICE as a measure of potential drug-drug interaction [ Time Frame: Predose, 30 minutes, 1, 2, 3, 4, 6, 8, 10 (optional), and 24 hours on day 15 (course 1) and day 1 (course 2) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219737
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Craig Sauter||Memorial Sloan Kettering Cancer Center|