Ignite Creation Date:
2024-05-06 @ 2:39 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02092324
Status:
COMPLETED
Last Update Posted:
2020-11-16
First Post:
2014-03-18
Brief Title:
Ruxolitinib Phosphate in Treating Patients With Chronic Neutrophilic Leukemia or Atypical Chronic Myeloid Leukemia
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
Prospective Evaluation of Ruxolitinib Efficacy for CNLaCML Patients With Mutation of CSF3R
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies how well ruxolitinib phosphate works in treating patients with chronic neutrophilic leukemia CNL or atypical chronic myeloid leukemia aCML Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cells to reproduce This trial also studies the genetic makeup of patients Certain genes in cancer cells may determine how the cancer grows or spreads and how it may respond to different drugs Studying how the genes associated with CNL and aCML respond to the study drug may help doctors learn more about CNL and aCML and improve the treatment for these diseases
Detailed Description:
PRIMARY OBJECTIVES
I To determine the proportion of patients with chronic neutrophilic leukemia CNL and atypical chronic myeloid leukemia aCML who have a hematologic response to ruxolitinib ruxolitinib phosphate partial response PR complete response CR complete response partial CRp
SECONDARY OBJECTIVES
I To determine the frequency of grade 3 or 4 hematologic and non-hematologic adverse events experienced by subjects during therapy with ruxolitinib
II To determine whether hematologic responses correlate with certain types of mutations in colony stimulating factor 3 receptor CSF3R and reduction in mutant CSF3R allele burden in the peripheral blood
III To determine the maximum clinical responses for each subject and the median duration of maximum clinical responses
IV To determine the mean reduction of spleen size estimated by volume using the conventional prolate ellipsoid method as measured by ultrasound compare to baseline
V To determine the mean reduction of total symptom score as measured by a modified Myeloproliferative Neoplasm Symptom Assessment Form version 20 MPN-SAF compared to start of study day 1 cycle 1
VI To determine overall survival in subjects who complete a minimum of 1 dose of study drug
VII To determine the proportion of subjects who discontinue after completion of 3 cycles but 6 cycles
VIII To determine the proportion of subjects who discontinue prior to completion of cycle 3
OUTLINE
Patients receive ruxolitinib phosphate orally PO every other day once daily QD or twice daily BID on days 1-28 Each patient will be followed for a maximum of 96 weeks 24 cycles 1 cycle is 4 weeks long If the study drug continues to be effective the patient may be eligible to continue on study drug past 24 cycles
After completion of study treatment patients are followed up within 2 weeks and at 4-6 weeks
I To determine the proportion of patients with chronic neutrophilic leukemia CNL and atypical chronic myeloid leukemia aCML who have a hematologic response to ruxolitinib ruxolitinib phosphate partial response PR complete response CR complete response partial CRp
SECONDARY OBJECTIVES
I To determine the frequency of grade 3 or 4 hematologic and non-hematologic adverse events experienced by subjects during therapy with ruxolitinib
II To determine whether hematologic responses correlate with certain types of mutations in colony stimulating factor 3 receptor CSF3R and reduction in mutant CSF3R allele burden in the peripheral blood
III To determine the maximum clinical responses for each subject and the median duration of maximum clinical responses
IV To determine the mean reduction of spleen size estimated by volume using the conventional prolate ellipsoid method as measured by ultrasound compare to baseline
V To determine the mean reduction of total symptom score as measured by a modified Myeloproliferative Neoplasm Symptom Assessment Form version 20 MPN-SAF compared to start of study day 1 cycle 1
VI To determine overall survival in subjects who complete a minimum of 1 dose of study drug
VII To determine the proportion of subjects who discontinue after completion of 3 cycles but 6 cycles
VIII To determine the proportion of subjects who discontinue prior to completion of cycle 3
OUTLINE
Patients receive ruxolitinib phosphate orally PO every other day once daily QD or twice daily BID on days 1-28 Each patient will be followed for a maximum of 96 weeks 24 cycles 1 cycle is 4 weeks long If the study drug continues to be effective the patient may be eligible to continue on study drug past 24 cycles
After completion of study treatment patients are followed up within 2 weeks and at 4-6 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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-2014-00633 | REGISTRY | None | None |
| IRB00010262 | OTHER | OHSU Knight Cancer Institute | None |