Ignite Creation Date:
2024-05-06 @ 3:58 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02415608
Status:
TERMINATED
Last Update Posted:
2018-09-20
First Post:
2015-03-24
Brief Title:
Ibrutinib in Treating Patients With Advanced Systemic Mastocytosis
Sponsor:
Jason Robert Gotlib
Organization:
Stanford University
Study Overview
Official Title:
A Phase 2 Study of Ibrutinib in Advanced Systemic Mastocytosis
Status:
TERMINATED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase 2 trial studies ibrutinib to see how well it works in treating patients with systemic affecting the entire body mastocytosis that has spread to other parts of the body and usually cannot be cured or controlled with treatment advanced Systemic mastocytosis is a disease in which too many mast cells a type of immune system cell are found throughout the body Mast cells give off chemicals such as histamine that can cause flushing a hot red face itching abdominal cramps muscle pain nausea vomiting diarrhea low blood pressure and shock Ibrutinib may stop the growth of mast cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVE
Evaluate the response rate to ibrutinib in patients with advanced systemic mastocytosis SM aggressive systemic mastocytosis ASM or mast cell leukemia MCL or SM-associated hematologic non-mast cell disorder AHNMD by the end of 6 cycles 6 months
SECONDARY OBJECTIVES
Evaluate the tolerability and safety profile of ibrutinib in patients with advanced SM
Evaluate the pharmacokinetic PK profile of ibrutinib in a subset of patients with advanced SM
Evaluate changes in histopathology blood and bone marrow of patients with advanced SM in response to ibrutinib therapy
Evaluate changes in mastocytosis related symptom scores and quality-of-life QOL using a modified Myeloproliferative Neoplasm Symptom Assessment Form MPNSAF
Evaluate the duration of response DoR and time to response TTR
Evaluate progression-free survival PFS and overall survival
OUTLINE
Patients receive ibrutinib orally PO once daily QD on days 1 to 28 Treatment repeats every 28 days for up to 6 months in the absence of disease progression or unacceptable toxicity Patients achieving an unconfirmed or confirmed clinical improvement CI partial response PR or complete response CR by the end of course 6 will be permitted to continue maintenance courses of ibrutinib on an ongoing basis until loss of responseprogressive disease or unacceptable toxicity
After completion of study treatment patients are followed up for 30 days and then every 6 months thereafter
Evaluate the response rate to ibrutinib in patients with advanced systemic mastocytosis SM aggressive systemic mastocytosis ASM or mast cell leukemia MCL or SM-associated hematologic non-mast cell disorder AHNMD by the end of 6 cycles 6 months
SECONDARY OBJECTIVES
Evaluate the tolerability and safety profile of ibrutinib in patients with advanced SM
Evaluate the pharmacokinetic PK profile of ibrutinib in a subset of patients with advanced SM
Evaluate changes in histopathology blood and bone marrow of patients with advanced SM in response to ibrutinib therapy
Evaluate changes in mastocytosis related symptom scores and quality-of-life QOL using a modified Myeloproliferative Neoplasm Symptom Assessment Form MPNSAF
Evaluate the duration of response DoR and time to response TTR
Evaluate progression-free survival PFS and overall survival
OUTLINE
Patients receive ibrutinib orally PO once daily QD on days 1 to 28 Treatment repeats every 28 days for up to 6 months in the absence of disease progression or unacceptable toxicity Patients achieving an unconfirmed or confirmed clinical improvement CI partial response PR or complete response CR by the end of course 6 will be permitted to continue maintenance courses of ibrutinib on an ongoing basis until loss of responseprogressive disease or unacceptable toxicity
After completion of study treatment patients are followed up for 30 days and then every 6 months thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA124435 | NIH | OnCore | httpsreporternihgovquickSearchP30CA124435 |
| NCI-2014-02341 | REGISTRY | None | None |
| HEMMPD0021 | OTHER | None | None |