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Pacritinib for Graft-versus-Host Disease
Phase 1 & 2
Waitlist Available
Led By Joseph Pidala, M.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 100 days
Awards & highlights
Study Summary
This trial is testing a new approach to preventing graft vs. host disease (GVHD), a serious problem that can occur after a transplant. The new approach combines three drugs, and this trial will test whether it is safe and effective.
Eligible Conditions
- Graft-versus-Host Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 100 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 100 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
STAT Activity
Secondary outcome measures
Incidence of Acute GVHD
Side effects data
From 2022 Phase 1 & 2 trial • 40 Patients • NCT0289160345%
Febrile neutropenia
41%
Mucositis oral
36%
Platelet count decreased
23%
Diarrhea
23%
Neutrophil count decreased
23%
Rash maculo-papular
18%
Anemia
18%
Hypertension
18%
Fatigue
14%
Headache
14%
Acute kidney injury
14%
Dehydration
9%
Anorexia
9%
Alanine aminotransferase increased
9%
Aspartate aminotransferase increased
9%
Hypotension
9%
Cellulitis
5%
Fever
5%
Multi-organ failure
5%
Lung infection
5%
C Diff
5%
Infusion related reaction
5%
Tremors
5%
Erythroderma -acute GVHD
5%
Folicular rash
5%
Rash over body
5%
Delirium
5%
Encephalitis - HHV6
5%
Encephalopathy
5%
Lung infection -Pneumonia
5%
Sepsis
5%
Mulit-organ failure
5%
Suspected VOD
5%
Abdominal distension
5%
Respiratory Failure
5%
Urinary tract pain
5%
Nausea
5%
Myocardial infarction
5%
Fall
5%
CPK increased
5%
Skin sloughing off
5%
Chills
5%
Tachycardia
5%
Fracture
5%
Electrocardiogram QT corrected interval prolonged
5%
Catheter related infection
5%
Bilirubin increase
5%
Dry mouth
5%
Creatinine increased
5%
White blood cell count decreased
5%
Abdominal Pain
5%
Sinusitis
5%
LDH Increased
5%
Alanine aminotransferase increased - VOD
5%
Alanine aminotransferase increased - suspected VOD
5%
Hypokalemia
5%
Erythroderma
5%
Diffuse rash on face, trunk, and extremities; eyelids swelling
5%
Pulmonary edema
5%
Dyspnea
5%
Hyponatremia
5%
Hypophosphatemia
5%
Meningitis
5%
Respiratory failure
5%
Insomnia
5%
Epistaxis
5%
Lethargy
5%
Gastrointestinal Disorders - Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2: Pacritinib With Sirolimus and Tacrolimus
Phase 1, Level 1: Pacritinib With Sirolimus and Tacrolimus
Phase 1, Level 2: Pacritinib With Sirolimus and Tacrolimus
Trial Design
3Treatment groups
Experimental Treatment
Group I: Phase 2: Pacritinib with Sirolimus and TacrolimusExperimental Treatment4 Interventions
After standard of care allogenic hematopoietic cell transplantation, Pacritinib will be added to standard treatment with Sirolimus and Tacrolimus (PAC/SIR/TAC).
Patients will take Pacritinib at the MTD: 100 mg Pacritinib will begin taken by mouth twice daily starting the day of the participant's transplant (Day 0) and continuing until 70 days after the transplant..
Sirolimus will be given the day before transplant and continued daily for at least one year.
Tacrolimus will begin 3 days before transplant and will be given for at least 50 days.
Group II: Phase 1, Level 2: Pacritinib with Sirolimus and TacrolimusExperimental Treatment4 Interventions
After standard of care allogenic hematopoietic cell transplantation, Pacritinib will be added to standard treatment with Sirolimus and Tacrolimus (PAC/SIR/TAC).
100 mg Pacritinib will begin taken by mouth twice daily starting the day of the participant's transplant (Day 0) and continuing until 70 days after the transplant..
Sirolimus will be given the day before transplant and continued daily for at least one year.
Tacrolimus will begin 3 days before transplant and will be given for at least 50 days.
Group III: Phase 1, Level 1: Pacritinib with Sirolimus and TacrolimusExperimental Treatment4 Interventions
After standard of care allogenic hematopoietic cell transplantation, Pacritinib will be added to standard treatment with Sirolimus and Tacrolimus (PAC/SIR/TAC).
100 mg Pacritinib will begin taken by mouth the day of the participant's transplant (Day 0) and will continue until 70 days after the transplant..
Sirolimus will be given the day before transplant and continued daily for at least one year.
Tacrolimus will begin 3 days before transplant and will be given for at least 50 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tacrolimus
2011
Completed Phase 4
~4740
Allogenic hematopoietic cell transplant (alloHCT)
2017
Completed Phase 2
~40
Sirolimus
2013
Completed Phase 4
~2750
Pacritinib
2017
Completed Phase 2
~330
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
543 Previous Clinical Trials
135,455 Total Patients Enrolled
CTI BioPharmaIndustry Sponsor
63 Previous Clinical Trials
5,333 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,587 Total Patients Enrolled
1 Trials studying Graft-versus-Host Disease
236 Patients Enrolled for Graft-versus-Host Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have experienced severe bleeding in the recent past or are currently experiencing ongoing severe bleeding.You have received certain medications (anti-thymocyte globulin, alemtuzumab, bortezomib, or post-transplant cyclophosphamide) to prevent graft-versus-host disease after a transplant.Your organs are working properly and are healthy.You have certain types of blood cancers like acute leukemia, myelodysplasia, chronic leukemia, or lymphoma that require a specific kind of stem cell transplant. For acute leukemia, you must be in complete remission with no signs of cancer. For myelodysplasia and chronic leukemia, you must have a low percentage of cancer cells. For myeloproliferative neoplasms, you must have a low percentage of cancer cells in your blood and bone marrow. For Hodgkin and non-Hodgkin lymphoma, you must have a good response to chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1, Level 1: Pacritinib with Sirolimus and Tacrolimus
- Group 2: Phase 2: Pacritinib with Sirolimus and Tacrolimus
- Group 3: Phase 1, Level 2: Pacritinib with Sirolimus and Tacrolimus
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any antecedent tests demonstrating the efficaciousness of Pacritinib?
"At the present moment, a total of 308 clinical trials involving Pacritinib are underway with 33 in Phase 3. Although many of them take place at medical centres located Philadelphia, Pennsylvania, there is representation from 8740 different sites worldwide."
Answered by AI
What medical conditions is Pacritinib typically employed to treat?
"Pacritinib is commonly prescribed to treat a wide range of medical issues, from organ transplant rejection to psoriasis and atopic dermatitis."
Answered by AI
What is the maximum capacity of participants in this clinical trial?
"The recruitment window for this clinical trial has closed, with the original posting on June 8th 2017 and last update occurring on July 27th 2022. If you are searching for alternate studies to join, there are 173 trials recruiting patients suffering from a range of diseases as well as 308 distinct trials actively seeking participants willing to take Pacritinib."
Answered by AI
Are the requirements for enrollment in this clinical trial currently open?
"Unfortunately, this research project is no longer actively seeking volunteers. The trial was initially posted on the 8th of June 2017 and the last revision took place 27th July 2022. There are 173 other trials currently calling for enrolment related to disease and 308 studies recruiting participants who would like to take part in Pacritinib testing."
Answered by AI
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