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Trial record 34 of 50 for:    "Essential Thrombocythemia" | "Anti-Infective Agents"

Pacritinib Before Transplant for Myeloproliferative Neoplasms (MPN)

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ClinicalTrials.gov Identifier: NCT02410551
Recruitment Status : Terminated
First Posted : April 7, 2015
Results First Posted : October 5, 2018
Last Update Posted : October 30, 2018
Sponsor:
Collaborator:
CTI BioPharma
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Myeloproliferative Diseases
Interventions Drug: Pacritinib
Drug: Busulfan
Behavioral: Questionnaires
Behavioral: Phone Calls
Procedure: Allogeneic Stem Cell Transplantation
Drug: Fludarabine
Enrollment 4
Recruitment Details Patients with Idiopathic Myelofibrosis or Myelofibrosis secondary to Ploycythemia Vera or Essential Thrombocythemia that are 18 to 70 years old that want to pursue a transplant. They start the Pacritinib per-transplant and can proceed to transplant 60 days after starting Pacritinib but no more than 180 days.
Pre-assignment Details  
Arm/Group Title Pacritinib Pre- Transplant
Hide Arm/Group Description Patients will start pacritinib 200 mg po bid and can proceed to transplant after 60 days of starting pacritinib but not more than 180 days
Period Title: Overall Study
Started 4
Completed 0
Not Completed 4
Reason Not Completed
Adverse Event             1
Withdrawal by Subject             1
FDA Clinical hold-patients taken off             2
Arm/Group Title Pacritinib Pre- Transplant
Hide Arm/Group Description Patients will start pacritinib 200 mg po bid and can proceed to transplant after 60 days of starting pacritinib but not more than
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  75.0%
>=65 years
1
  25.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
3
  75.0%
Male
1
  25.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Hispanic or Latino
1
  25.0%
Not Hispanic or Latino
3
  75.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
4
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description The protocol was to enroll at least 21 evaluable participants, defined as patients who received Pacritinib for >/=60 days but less than 180 days. We enrolled four participants, however all four were not evaluable since no one was able to complete 60 days of Pacritinib.
Time Frame participants who received Pacritinib for >/= 60 days but less than 180 days who undergo transplant with a matched related or at least 7/8 matched unrelated donor. The protocol was to evaluate progression free survival at one year.
Hide Outcome Measure Data
Hide Analysis Population Description
Four participants were not evaluable and no analysis was done.
Arm/Group Title Pacritinib Pre- Transplant
Hide Arm/Group Description:
Patients will start pacritinib 200 mg po bid and can proceed to transplant after 60 days of starting pacritinib but not more than
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Other Pre-specified Outcome
Title Evaluate Safety and Efficacy of Pacritinib.
Hide Description Evaluate safety and efficacy of this therapy determined by Neutrophil and platelet engraftment, Non-relapse mortality at one year post transplant, Overall survival at one year post transplant, Liver and spleen response to Pacritinib, Immune recovery, quality of life and symptom score, Primary and secondary graft failure,Complete remission, Relapse.
Time Frame Start of Pacritinib to one year post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Four participants was invaluable and no analysis was done.
Arm/Group Title Pacritinib Pre- Transplant
Hide Arm/Group Description:
Patients will start pacritinib 200 mg po bid and can proceed to transplant after 60 days of starting pacritinib but not more than 180 days
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 07/31/2015 to 02/25/2016
Adverse Event Reporting Description The severity of the adverse events (AEs) will be graded according to the Common Terminology Criteria v4.0 (CTCAE). We will not capture expected Grade 1 and Grade 2 AEs. Grade 3 and 4 AEs will be collected and recorded in the medical record. Only Pacritinib-related adverse events and protocol specific data will be entered into PDMS/CORe. PDMS/CORE will be used as the electronic case report form for this protocol.
 
Arm/Group Title Pacritinib Pre- Transplant
Hide Arm/Group Description Patients will start pacritinib 200 mg po bid and can proceed to transplant after 60 days of starting pacritinib but not more than
All-Cause Mortality
Pacritinib Pre- Transplant
Affected / at Risk (%)
Total   0/4 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Pacritinib Pre- Transplant
Affected / at Risk (%)
Total   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Pacritinib Pre- Transplant
Affected / at Risk (%)
Total   1/4 (25.00%) 
Skin and subcutaneous tissue disorders   
Rash maculo-papular  1  1/4 (25.00%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Popat,Uday,M.D. / Stem Cell Transplantation
Organization: UT MD Anderson Cancer Center
Phone: 713-792-8750
EMail: upopat@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02410551     History of Changes
Other Study ID Numbers: 2014-0786
NCI-2015-01123 ( Registry Identifier: NCI CTRP )
First Submitted: April 2, 2015
First Posted: April 7, 2015
Results First Submitted: February 28, 2018
Results First Posted: October 5, 2018
Last Update Posted: October 30, 2018