Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04517851
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2020-08-14
Brief Title:
Elotuzumab for the Treatment of JAK2-Mutated Myelofibrosis
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Pilot Study of the Anti-SLAMF7 Monoclonal Antibody Elotuzumab in Patients With Myelofibrosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial investigates how well elotuzumab works in treating patients with JAK2-mutated myelofibrosis Elotuzumab may help to control myelofibrosis andor help to improve blood cell count and bone marrow function
Detailed Description:
PRIMARY OBJECTIVE
I To obtain preliminary evidence of the efficacy of elotuzumab in patients with myelofibrosis MF by estimating the rate of overall response by International Working Group-Myeloproliferative Neoplasms Research and Treatment IWG-MRT 2013 criteria
SECONDARY OBJECTIVES
I To characterize the safety and tolerability of elotuzumab in patients with MF
II To assess for improvements in cytopenias and bone marrow fibrosis grade splenomegaly and disease-related symptoms
III To determine the duration of objective responses if any to elotuzumab IV To determine the time to next treatment
EXPLORATORY OBJECTIVES
I To assess the proportion of circulating monocytes expressing the target of elotuzumab SLAMF7 and any correlation of the same to the mutant JAK2 allele burden
II To assess baseline levels of IL-1Ralpha and other cytokines and the effects of elotuzumab if any on these over time
III To examine the effects of elotuzumab on fibrocyte count and differentiation both in vitro and in vivo
IV To assess clonal evolution if any in MF patients on elotuzumab treatment
OUTLINE
Patients receive elotuzumab intravenously IV over 1-4 hours on days 1 8 15 and 22 of cycles 1-2 Beginning in cycle 3 patients receive elotuzumab IV over 1-4 hours on day 1 Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days and then periodically thereafter
I To obtain preliminary evidence of the efficacy of elotuzumab in patients with myelofibrosis MF by estimating the rate of overall response by International Working Group-Myeloproliferative Neoplasms Research and Treatment IWG-MRT 2013 criteria
SECONDARY OBJECTIVES
I To characterize the safety and tolerability of elotuzumab in patients with MF
II To assess for improvements in cytopenias and bone marrow fibrosis grade splenomegaly and disease-related symptoms
III To determine the duration of objective responses if any to elotuzumab IV To determine the time to next treatment
EXPLORATORY OBJECTIVES
I To assess the proportion of circulating monocytes expressing the target of elotuzumab SLAMF7 and any correlation of the same to the mutant JAK2 allele burden
II To assess baseline levels of IL-1Ralpha and other cytokines and the effects of elotuzumab if any on these over time
III To examine the effects of elotuzumab on fibrocyte count and differentiation both in vitro and in vivo
IV To assess clonal evolution if any in MF patients on elotuzumab treatment
OUTLINE
Patients receive elotuzumab intravenously IV over 1-4 hours on days 1 8 15 and 22 of cycles 1-2 Beginning in cycle 3 patients receive elotuzumab IV over 1-4 hours on day 1 Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days and then periodically 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 |
|---|---|---|---|
| NCI-2020-05712 | REGISTRY | None | None |
| 2020-0522 | OTHER | M D Anderson Cancer Center | None |