Trial Outcomes & Findings for Study of Ixazomib to Prevent Recurrent or Late Acute and Chronic Graft-versus-Host Disease 1-year After Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Hematologic Malignancies (NCT NCT03082677)
NCT ID: NCT03082677
Last Updated: 2022-09-27
Results Overview
Therapeutic response will be determined by the absence of grade II-IV aGVHD or chronic GVHD diagnostic features.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
1 year
Results posted on
2022-09-27
Participant Flow
Participant milestones
| Measure |
Ixazomib
Ixazomib beginning between day +100 to +150 at a dose of 4 mg orally once per week (3 weeks on/ 1 week off). The patients will continue on this same dose until taper off from immunosuppressants or 1 year post-HSCT is reached (whichever occurs first) or until the patient develops GVHD or malignant disease relapse/progression occurs.
Ixazomib: Ixazomib beginning between day +100 to +150 at a dose of 4 mg orally once per week (3 weeks on/ 1 week off).
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Ixazomib
Ixazomib beginning between day +100 to +150 at a dose of 4 mg orally once per week (3 weeks on/ 1 week off). The patients will continue on this same dose until taper off from immunosuppressants or 1 year post-HSCT is reached (whichever occurs first) or until the patient develops GVHD or malignant disease relapse/progression occurs.
Ixazomib: Ixazomib beginning between day +100 to +150 at a dose of 4 mg orally once per week (3 weeks on/ 1 week off).
|
|---|---|
|
Overall Study
Not Treated
|
2
|
Baseline Characteristics
Study of Ixazomib to Prevent Recurrent or Late Acute and Chronic Graft-versus-Host Disease 1-year After Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Hematologic Malignancies
Baseline characteristics by cohort
| Measure |
Ixazomib
n=20 Participants
Ixazomib beginning between day +100 to +150 at a dose of 4 mg orally once per week (3 weeks on/ 1 week off). The patients will continue on this same dose until taper off from immunosuppressants or 1 year post-HSCT is reached (whichever occurs first) or until the patient develops GVHD or malignant disease relapse/progression occurs.
Ixazomib: Ixazomib beginning between day +100 to +150 at a dose of 4 mg orally once per week (3 weeks on/ 1 week off).
|
|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearTherapeutic response will be determined by the absence of grade II-IV aGVHD or chronic GVHD diagnostic features.
Outcome measures
| Measure |
Ixazomib
n=18 Participants
Ixazomib beginning between day +100 to +150 at a dose of 4 mg orally once per week (3 weeks on/ 1 week off). The patients will continue on this same dose until taper off from immunosuppressants or 1 year post-HSCT is reached (whichever occurs first) or until the patient develops GVHD or malignant disease relapse/progression occurs.
Ixazomib: Ixazomib beginning between day +100 to +150 at a dose of 4 mg orally once per week (3 weeks on/ 1 week off).
|
|---|---|
|
Number of Patients Absence of Grade II-IV aGVHD or Chronic GVHD Diagnostic Features
No aGCHD or cGVHD
|
13 Participants
|
|
Number of Patients Absence of Grade II-IV aGVHD or Chronic GVHD Diagnostic Features
aGCHD or cGVHD
|
5 Participants
|
Adverse Events
Ixazomib
Serious events: 2 serious events
Other events: 18 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Ixazomib
n=18 participants at risk
Ixazomib beginning between day +100 to +150 at a dose of 4 mg orally once per week (3 weeks on/ 1 week off). The patients will continue on this same dose until taper off from immunosuppressants or 1 year post-HSCT is reached (whichever occurs first) or until the patient develops GVHD or malignant disease relapse/progression occurs.
Ixazomib: Ixazomib beginning between day +100 to +150 at a dose of 4 mg orally once per week (3 weeks on/ 1 week off).
|
|---|---|
|
General disorders
Fever
|
5.6%
1/18 • 1 year
|
|
Infections and infestations
Lung infection
|
5.6%
1/18 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.6%
1/18 • 1 year
|
|
Nervous system disorders
Vasovagal reaction
|
5.6%
1/18 • 1 year
|
Other adverse events
| Measure |
Ixazomib
n=18 participants at risk
Ixazomib beginning between day +100 to +150 at a dose of 4 mg orally once per week (3 weeks on/ 1 week off). The patients will continue on this same dose until taper off from immunosuppressants or 1 year post-HSCT is reached (whichever occurs first) or until the patient develops GVHD or malignant disease relapse/progression occurs.
Ixazomib: Ixazomib beginning between day +100 to +150 at a dose of 4 mg orally once per week (3 weeks on/ 1 week off).
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
9/18 • 1 year
|
|
Investigations
APTT time prolonged
|
5.6%
1/18 • 1 year
|
|
Blood and lymphatic system disorders
Lymphopenia
|
33.3%
6/18 • 1 year
|
|
Blood and lymphatic system disorders
Neutropenia
|
38.9%
7/18 • 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
6/18 • 1 year
|
|
Blood and lymphatic system disorders
Leukopenia
|
50.0%
9/18 • 1 year
|
|
Cardiac disorders
Chest pain
|
5.6%
1/18 • 1 year
|
|
Cardiac disorders
Pericardial effusion
|
5.6%
1/18 • 1 year
|
|
Cardiac disorders
Peripheral edema
|
5.6%
1/18 • 1 year
|
|
Endocrine disorders
Hypothyroidism
|
5.6%
1/18 • 1 year
|
|
Ear and labyrinth disorders
Hearing impaired
|
5.6%
1/18 • 1 year
|
|
Gastrointestinal disorders
Mouth pain
|
5.6%
1/18 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.1%
2/18 • 1 year
|
|
Gastrointestinal disorders
Oral pain
|
5.6%
1/18 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Post-nasal drip
|
5.6%
1/18 • 1 year
|
|
Infections and infestations
Conjunctivitis
|
5.6%
1/18 • 1 year
|
|
Eye disorders
Eye pain
|
5.6%
1/18 • 1 year
|
|
Eye disorders
Dry eye
|
5.6%
1/18 • 1 year
|
|
Investigations
Elevated alanine aminotransferase
|
44.4%
8/18 • 1 year
|
|
Investigations
Elevated alkaline phosphatase
|
5.6%
1/18 • 1 year
|
|
Investigations
Elevated aspartate aminotransferase
|
61.1%
11/18 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
5.6%
1/18 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
44.4%
8/18 • 1 year
|
|
Nervous system disorders
Dysgeusia
|
5.6%
1/18 • 1 year
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
1/18 • 1 year
|
|
Gastrointestinal disorders
GERD
|
5.6%
1/18 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
22.2%
4/18 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • 1 year
|
|
General disorders
Fever
|
5.6%
1/18 • 1 year
|
|
General disorders
Pain
|
11.1%
2/18 • 1 year
|
|
General disorders
Weight Gain
|
5.6%
1/18 • 1 year
|
|
Infections and infestations
Bronchial infection
|
5.6%
1/18 • 1 year
|
|
Infections and infestations
Lung infection
|
11.1%
2/18 • 1 year
|
|
Infections and infestations
Skin infection
|
5.6%
1/18 • 1 year
|
|
Infections and infestations
Sinusitis
|
5.6%
1/18 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
1/18 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
2/18 • 1 year
|
|
Investigations
Cholesterol high
|
27.8%
5/18 • 1 year
|
|
Investigations
Creatinine increased
|
16.7%
3/18 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
72.2%
13/18 • 1 year
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.6%
1/18 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
6/18 • 1 year
|
|
Metabolism and nutrition disorders
Hypernatremia
|
16.7%
3/18 • 1 year
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
22.2%
4/18 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.6%
1/18 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
22.2%
4/18 • 1 year
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
11.1%
2/18 • 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
38.9%
7/18 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.1%
2/18 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.6%
1/18 • 1 year
|
|
Nervous system disorders
Headache
|
11.1%
2/18 • 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.6%
1/18 • 1 year
|
|
Nervous system disorders
Tremor
|
11.1%
2/18 • 1 year
|
|
Reproductive system and breast disorders
Vaginal discharge
|
5.6%
1/18 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
6/18 • 1 year
|
|
Skin and subcutaneous tissue disorders
Xerodermia
|
11.1%
2/18 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
5.6%
1/18 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash, acneiform
|
11.1%
2/18 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash, maculo-papular
|
22.2%
4/18 • 1 year
|
Additional Information
Dr. Doris Ponce, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-608-3739
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place