Myeloid Hematologic MalignancyPhase 2NCT03082677
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
A Phase 2 study testing Ixazomib in people with Myeloid Hematologic Malignancy and Lymphoid Hematologic Malignancy, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloid Hematologic Malignancy, Lymphoid Hematologic Malignancy
- What is being tested?
- Ixazomib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2017to 2 Sep 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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.
- Being tested
- Ixazomib
- Keywords
- Ixazomib, Graft-versus-Host Disease, Allogeneic Hematopoietic Stem Cell Transplantation, 16-076
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IxazomibDrug
Also called MLN 9708
Ixazomib beginning between day +100 to +150 at a dose of 4 mg orally once per week (3 weeks on/ 1 week off).
| Study group | Role | What they receive |
|---|---|---|
| ixazomib | Experimental | 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. Receives: Drug: Ixazomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Absence of Grade II-IV aGVHD or Chronic GVHD Diagnostic Features
Therapeutic response will be determined by the absence of grade II-IV aGVHD or chronic GVHD diagnostic features.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start10 Mar 2017
- Primary completion2 Sep 2021
- Study completion2 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Myeloid Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single arm phase 2 study to evaluate a post-transplant proteasome inhibitor, ixazomib, as prophylaxis against recurrent or late acute and chronic GVHD. Ixazomib will be initiated within days 100 to 150 post-transplant in patient's ≥ 18 years-old with either myeloid or lymphoid hematologic malignancy treated with a RI or NMA HSCT and will have received calcineurin inhibitor based drug (tacrolimus or cyclosporin) and methotrexate as part of their initial GVHD prophylaxis.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium: The Takeda Oncology Company
- Responsible party
- Sponsor
- Investigators
- Doris M Ponce, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082677
- Sponsor's protocol ID
- 16-076
- Status last verified
- Sep 2021
- First submitted
- 13 Mar 2017
- Last updated
- 27 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03082677
- Acronym / sponsor ID
- 16-076
- Keywords
- Ixazomib, Graft-versus-Host Disease, Allogeneic Hematopoietic Stem Cell Transplantation, 16-076
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Millennium: The Takeda Oncology Company
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 2 Sep 2021 (actual)
- Study completion
- 2 Sep 2021 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Posted 27 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm phase 2 study to evaluate a post-transplant proteasome inhibitor, ixazomib, as prophylaxis against recurrent or late acute and chronic GVHD. Ixazomib will be initiated within days 100 to 150 post-transplant in patient's ≥ 18 years-old with either myeloid or lymphoid hematologic malignancy treated with a RI or NMA HSCT and will have received calcineurin inhibitor based drug (tacrolimus or cyclosporin) and methotrexate as part of their initial GVHD prophylaxis.
| Arm | Type | Receives |
|---|---|---|
| ixazomib | Experimental | Drug: IxazomibIxazomib 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
- Male patients, even if surgically sterilized (i.e. Status post-vasectomy) must agree to one of the following:
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IxazomibAlso: MLN 9708Ixazomib beginning between day +100 to +150 at a dose of 4 mg orally once per week (3 weeks on/ 1 week off). | Drug | ixazomib |
Primary outcome
Number of Patients Absence of Grade II-IV aGVHD or Chronic GVHD Diagnostic Features
Time frame: 1 year
Therapeutic response will be determined by the absence of grade II-IV aGVHD or chronic GVHD diagnostic features.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doris M Ponce, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ixazomib in people with Myeloid Hematologic Malignancy and Lymphoid Hematologic Malignancy, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Absence of Grade II-IV aGVHD or Chronic GVHD Diagnostic Features (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.