- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03082677
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
August 30, 2022 updated by: Memorial Sloan Kettering Cancer Center
Open Label Phase II Study of Ixazomib for the Prevention of Recurrent or Late Acute and Chronic Graft-versus-Host Disease at 1-year After Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Hematologic Malignancies
This is a single arm open label phase 2 study evaluating the potential effect of ixazomib on the prevention of recurrent or late acute graft-versus-host disease (GVHD) and chronic GVHD at 1-year following reduced intensity (RI) or non-myeloablative (NMA) allogeneic hematopoietic stem cell transplantation (HSCT) for the treatment of hematologic malignancies.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients 18 years or older.
- Diagnosis: myeloid or lymphoid hematologic malignancy treated with a RI or NMA conditioning HSCT who received calcineurin inhibitor based drug (for example: tacrolimus or cyclosporin) and methotrexate as part of their initial GVHD prophylaxis. Patients who received sirolimus as part of their GVHD prophylaxis will be eligible.
- Recipients of 8-7/8 HLA-matched donor. Post-HSCT period within day +100 to day +150.
Female patients who:
- Are postmenopausal for at least 1 year before the screening visit, OR
- Are surgically sterile, OR
- If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence and withdrawal are not acceptable methods of contraception).
Male patients, even if surgically sterilized (i.e. Status post-vasectomy) must agree to one of the following:
- Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence and withdrawal are not acceptable methods of contraception).
- Organ Function and Performance Status Criteria:
- Karnofsky score ≥ 70 %
- Absolute neutrophil count (ANC) ≥ 1000/mm3 and platelet count ≥ 75,000/mm3. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment.
- Calculated creatinine clearance ≥ 30 mL/min (based on the Cockcroft and Gault method)
- Total bilirubin ≤ 1.5 x upper limit of normal range (ULN).
- AST/ALT ≤ 3 x ULN (unless benign congenital hyperbilirubinemia).
- Hemoglobin > 8.0 g/dL. Red blood cell transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment.
Exclusion Criteria:
- Disease: evidence of progressive disease at the time of study enrollment.
- Prior Therapy: one or more prior allogeneic stem cell transplantation (prior autologous transplant is acceptable).
- Active acute or chronic GVHD.
- Active and uncontrolled infection.
- Pregnant or breast feeding.
- Major surgery within 14 days before enrollment.
- Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
- Systemic treatment, within 14 days before the first dose of ixazomib, with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of CYP3A (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort.
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- Patient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up and research tests.
- Patients with known allergy to boron or boron-containing products, or excipients in the various formulations of any agent.
- Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing.
- Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
- Patient with ≥ Grade 3 peripheral neuropathy, or Grade 2 with pain on clinical examination during the screening period.
- Received post-transplant cyclophosphamide
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 beginning between day +100 to +150 at a dose of 4 mg orally once per week (3 weeks on/ 1 week off).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients Absence of Grade II-IV aGVHD or Chronic GVHD Diagnostic Features
Time Frame: 1 year
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Therapeutic response will be determined by the absence of grade II-IV aGVHD or chronic GVHD diagnostic features.
|
1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Doris M Ponce, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 10, 2017
Primary Completion (Actual)
September 2, 2021
Study Completion (Actual)
September 2, 2021
Study Registration Dates
First Submitted
March 13, 2017
First Submitted That Met QC Criteria
March 13, 2017
First Posted (Actual)
March 17, 2017
Study Record Updates
Last Update Posted (Actual)
September 27, 2022
Last Update Submitted That Met QC Criteria
August 30, 2022
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-076
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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