Ibrutinib and Blinatumomab in Treating Patients With Relapsed or Refractory B Acute Lymphoblastic Leukemia
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|ClinicalTrials.gov Identifier: NCT02997761|
Recruitment Status : Recruiting
First Posted : December 20, 2016
Last Update Posted : March 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Adult B Acute Lymphoblastic Leukemia Philadelphia Chromosome Positive||Biological: Blinatumomab Drug: Ibrutinib||Phase 2|
I. To evaluate the efficacy of ibrutinib and blinatumomab in patients with relapsed or refractory B acute lymphoblastic leukemia (B-ALL) as measured by complete response (CR) rate.
I. To further examine the efficacy and safety of ibrutinib and blinatumomab in patients with relapsed or refractory B-ALL as measured by overall response rate (ORR, defined as CR plus CR with incomplete count recovery [CRi]), relapse free survival (RFS), overall survival (OS), minimal residual disease (MRD) response, proportion of patients bridged to allogeneic hematopoietic cell transplant (allo-HCT), and toxicity.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Ibrutinib and Blinatumomab in Relapsed and Refractory B-Cell Acute Lymphoblastic Leukemia|
|Actual Study Start Date :||June 27, 2017|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||January 2021|
Experimental: Treatment (ibrutinib, blinatumomab)
INDUCTION THERAPY: Patients receive ibrutinib PO QD on days 1-49 of course 1 and days 1-42 of course 2, and blinatumomab IV on days 8-35 of course 1 and days 1-28 of course 2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION THERAPY: Patients with CR/CRi after Induction Therapy receive ibrutinib PO QD on days 1-42 and blinatumomab IV on days 1-28. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Rate of CR [ Time Frame: Up to 91 days ]
- Incidence of adverse events graded according to the National Cancer Institute CTCAE v4.03 [ Time Frame: Up to 6 months ]
- MRD response [ Time Frame: Up to 6 months ]
- ORR defined as CR plus CRi assessed by disease-specific response criteria [ Time Frame: Up to 6 months ]
- OS [ Time Frame: From the time of first study drug administration until the date of progression or death from any cause, assessed for up to 6 months ]
- RFS [ Time Frame: Time from CR/CRi until the date of progression or death from any cause, assessed for up to 6 months ]
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): NCT02997761
|United States, California|
|University of California Davis Comprehensive Cancer Center||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Brian A. Jonas 916-734-3772 firstname.lastname@example.org|
|Principal Investigator: Brian A. Jonas|
|Principal Investigator:||Brian Jonas||University of California, Davis|