Mantle Cell LymphomaPhase 2NCT03616782
Ixazomib Maintenance in Patients With Newly Diagnosed Mantle Cell Lymphoma(MCL)
A Phase 2 study testing Ixazomib in people with Mantle Cell Lymphoma, run by Ho Sup Lee at 1 site in South Korea.
Trial summary
1. Induction chemotherapy 1) RCHOP(Rituximab+Cyclophosphamide+Doxorubicin+Vincristine+Prednisone) 2) VR-CAP (Bortezomib+Rituximab+Cyclophosphamide+Doxorubicin+Prednisone) Patients who have received induction chemotherapy will be evaluated for responses and those who achieved more than PR(Partial response) or PR will… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- Ixazomib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Dec 2018to 31 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged ≥19 years
- Histologically confirmed mantle cell lymphoma (MCL) meeting the following criteria: determined by histology and either expression of cyclin D1 (in association with CD20 and CD5) or evidence of t(11;14) translocation (by cytogenetics, fluorescence in-situ hybridization, or polymerase chain reaction)
- In all patients, a paraffin-embedded biopsy tissue block or slides (preferably of lymph node origin or bone marrow) was sent to central laboratories (Diagnostic Cytology Laboratories or department of pathology) for confirmation of diagnosis of MCL.
- Stage II, III, or IV
- Patients who received RCHOP or VR-CAP induction chemotherapy for 6 cycles confirmed response as more than PR or PR after induction therapy and who are ineligible for transplantation. .
- No clinical evidence of central nervous system (CNS) involvement by lymphoma
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- Patients must have measurable disease; CT scans at baseline are required to define the extent of measurable disease; the scans must be obtained within 6 weeks prior to registration; combined CT/PET scans may be used for the baseline and subsequent evaluations if accurate tumor measurements can be obtained from the CT component
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Absolute neutrophil count (ANC) > 1,000 mm^3 (unless low count due to marrow involvement or splenomegaly)
- Platelets > 75,000 mm^3 (unless low counts due to marrow involvement or splenomegaly)
- Creatinine clearance of ≥ 30 mL/min
- Total bilirubin ≤ 1.5 x the upper limit of normal (may be up to 3.0 mg/dL if due to Gilbert's disease or due to liver involvement by lymphoma), alanine transaminase level ≤3 times the upper limit of normal; aspartate transaminase level ≤3 times the upper limit of normal
- Patients over the age of 45 must have a left ventricular ejection fraction (LVEF) of greater than 45% documented within 90 days prior to registration
- Female patients had to be post-menopausal for ≥1 year, surgically sterile, or practicing an effective method of birth control (as described in the protocol), and have a negative serum beta-human chorionic gonadotropin or urine pregnancy test at screening; they also had to agree to continue using birth control measures for ≥6 months after terminating treatment. Male patients had to agree to use an acceptable method of contraception for the duration of the study.
Who cannot join
- Female patients who are lactating or have a positive serum pregnancy test during the screening period.
- Grade 2 or higher baseline peripheral neuropathy
- Major surgery within 14 days before enrollment.
- Radiotherapy within 14 days before enrollment. If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib.
- Central nervous system involvement.
- Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study 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 CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort.
- Active systemic infection requiring treatment, a known diagnosis of human HIV, or active hepatitis B (hepatitis B carriers were permitted)
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
- Known gastrointestinal(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 has more than Grade 2 peripheral neuropathy on clinical examination during the screening period.
- Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial.
- Patients that have previously been treated with ixazomib, or participated in a study with ixazomib whether treated with ixazomib or not.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kosin University Gospel Hospital
Busan, Western, 49267
Ho Sup Lee, MI, 82-51-990-6363, hs3667@hanmail.net
About this study
Official title: Multicenter Phase II Study of Ixazomib Maintenance in Patients With Newly Diagnosed Mantle Cell Lymphoma
- Induction chemotherapy 1) RCHOP(Rituximab+Cyclophosphamide+Doxorubicin+Vincristine+Prednisone) 2) VR-CAP (Bortezomib+Rituximab+Cyclophosphamide+Doxorubicin+Prednisone) Patients who have received induction chemotherapy will be evaluated for responses and those who achieved more than PR(Partial response) or PR will be eligible for this study after receiving informed consents.
- Experimental step Maintenance ixazomib beginning at least 8 weeks after completion of induction chemotherapy, patients receive ixazomib per oral 3 mg on day 1, 8, and 15 for 4 weeks. And the dose of ixazomib can be escalated to 4mg by response such as partial response or MRD positive. Treatment repeats every 4 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
Patients are screened and sign the informed consent after completion induction chemotherapy (RCHOP or VR-CAP) with more than PR or PR confirmed. It is likely to take approximately 8 weeks in performing above procedures.
Read more
Patients start maintenance therapy at least 8 weeks and also can be allowed for the extension of 4 weeks because of delayed response evaluation, recovery toxicities of chemotherapy, and official process including agree with informed consent. Recently, ongoing studies about maintenance therapy in lymphoma have window periods of 8-12 weeks.
Ixazomib maintenance should continue for 2 years.
Read the detailed description
- Induction chemotherapy 1) RCHOP: Before enrollments, patients receive comprising R-CHOP, as induction therapy, comprised rituximab (at a dose of 375 mg per square meter of body-surface area), cyclophosphamide (750 mg per square meter), doxorubicin (50 mg per square meter), vincristine (1.4mg per square meter) administered on days 1, and oral prednisone (100 mg per square meter) administered on days 1 to 5. Patients also receive pegylated granulocyte-colonly stimulating factor (G-CSF) subcutaneously (SC) on day 2 to day 5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. VR-CAP: Before enrollments, patients receive comprising VR-CAP, as induction therapy, comprised bortezomib (1.3 mg per square meter of body-surface area) administered on days 1, 4, 8, 11, rituximab (at a dose of 375 mg per square meter), cyclophosphamide (750 mg per square meter), doxorubicin (50 mg per square meter) administered on days 1, and oral prednisone (100 mg per square meter) administered on days 1 to 5. Patients also receive pegylated G-CSF SC on day 2 to day 5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who have received induction chemotherapy will be evaluated for responses and those who achieved more than PR(Partial response) or PR will be eligible for this study after receiving informed consents.
- Experimental step Maintenance ixazomib beginning at least 8 weeks after completion of induction chemotherapy, patients receive ixazomib per oral 3 mg on day 1, 8, and 15 for 4 weeks. And the dose of ixazomib can be escalated to 4mg by response such as partial response or MTD(Maximum Tolerated Dose) positive. Treatment repeats every 4 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
Patients are screened and sign the informed consent after completion induction chemotherapy (RCHOP or VR-CAP) with more than PR or PR confirmed. It is likely to take approximately 8 weeks in performing above procedures.
Patients start maintenance therapy at least 8 weeks and also can be allowed for the extension of 4 weeks because of delayed response evaluation, recovery toxicities of chemotherapy, and official process including agree with informed consent. Recently, ongoing studies about maintenance therapy in lymphoma have window periods of 8-12 weeks.
Ixazomib maintenance should continue for 2 years.
- Conditions
- Mantle Cell Lymphoma
- Being tested
- Ixazomib
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IxazomibDrug
Ixazomib 3mg on day 1, 8, 15 q 4 weeks for 24 months or until progression
| Study group | Role | What they receive |
|---|---|---|
| Ixazomib | Experimental | Ixazomib 3mg on day a, 8, 15 q 4 weeks for 24 months or until to progression Receives: Drug: Ixazomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year PFS rates in adult patients with newly diagnosed Mantle Cell Lymphoma
Measured: 2years
Secondary outcomes (6)
Complete Response (CR) achievement rates after ixazomib maintenance by Lugano classification
Measured: an average of 2 year
Overall survival (OS) rates at 2 years
overall survival of patients with Mantle Cell Lymphoma
Measured: 2years
Adverse events (AEs)
Adverse events will be measured by the CTCAE scale, version 4.03
Measured: 2years
Time to relapse/progression
Time to progression is measured from the date of start of study to the date of relapse/progression
Measured: 2years
Time to next therapy (TTNT)
Measured: 2years
Minimal residual disease (MRD) by IgH or IgK NGS from BM, lymphoma tissue at the baseline and then peripheral blood (cell free DNA).
Measured: Screening, 24weeks, 4weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start24 Dec 2018
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle Cell LymphomaStudies of the same condition, open and under way.
- 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
- Ixazomib 3mg on day 1, 8, 15 q 4 weeks for 24months or untile to progression
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ho Sup Lee
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Sponsor-investigator, Ho Sup Lee, Kosin University Gospel Hospital
- Investigators
- Ho Sup Lee, MD, Principal investigator, Kosin University Gospel Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616782
- Sponsor's protocol ID
- FIXATION
- Status last verified
- Oct 2023
- First submitted
- 9 Jul 2018
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase II Study of Ixazomib Maintenance in Patients With Newly Diagnosed Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03616782
- Acronym / sponsor ID
- FIXATION
- Conditions
- Mantle Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Ho Sup LeeUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- 24 Dec 2018 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Induction chemotherapy 1) RCHOP(Rituximab+Cyclophosphamide+Doxorubicin+Vincristine+Prednisone) 2) VR-CAP (Bortezomib+Rituximab+Cyclophosphamide+Doxorubicin+Prednisone) Patients who have received induction chemotherapy will be evaluated for responses and those who achieved more than PR(Partial response) or PR will be eligible for this study after receiving informed consents.
- Experimental step Maintenance ixazomib beginning at least 8 weeks after completion of induction chemotherapy, patients receive ixazomib per oral 3 mg on day 1, 8, and 15 for 4 weeks. And the dose of ixazomib can be escalated to 4mg by response such as partial response or MRD positive. Treatment repeats every 4 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
Patients are screened and sign the informed consent after completion induction chemotherapy (RCHOP or VR-CAP) with more than PR or PR confirmed. It is likely to take approximately 8 weeks in performing above procedures.
Patients start maintenance therapy at least 8 weeks and also can be allowed for the extension of 4 weeks because of delayed response evaluation, recovery toxicities of chemotherapy, and official process including agree with informed consent. Recently, ongoing studies about maintenance therapy in lymphoma have window periods of 8-12 weeks.
Ixazomib maintenance should continue for 2 years.
Detailed description
- Induction chemotherapy 1) RCHOP: Before enrollments, patients receive comprising R-CHOP, as induction therapy, comprised rituximab (at a dose of 375 mg per square meter of body-surface area), cyclophosphamide (750 mg per square meter), doxorubicin (50 mg per square meter), vincristine (1.4mg per square meter) administered on days 1, and oral prednisone (100 mg per square meter) administered on days 1 to 5. Patients also receive pegylated granulocyte-colonly stimulating factor (G-CSF) subcutaneously (SC) on day 2 to day 5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. VR-CAP: Before enrollments, patients receive comprising VR-CAP, as induction therapy, comprised bortezomib (1.3 mg per square meter of body-surface area) administered on days 1, 4, 8, 11, rituximab (at a dose of 375 mg per square meter), cyclophosphamide (750 mg per square meter), doxorubicin (50 mg per square meter) administered on days 1, and oral prednisone (100 mg per square meter) administered on days 1 to 5. Patients also receive pegylated G-CSF SC on day 2 to day 5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who have received induction chemotherapy will be evaluated for responses and those who achieved more than PR(Partial response) or PR will be eligible for this study after receiving informed consents.
- Experimental step Maintenance ixazomib beginning at least 8 weeks after completion of induction chemotherapy, patients receive ixazomib per oral 3 mg on day 1, 8, and 15 for 4 weeks. And the dose of ixazomib can be escalated to 4mg by response such as partial response or MTD(Maximum Tolerated Dose) positive. Treatment repeats every 4 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
Patients are screened and sign the informed consent after completion induction chemotherapy (RCHOP or VR-CAP) with more than PR or PR confirmed. It is likely to take approximately 8 weeks in performing above procedures.
Patients start maintenance therapy at least 8 weeks and also can be allowed for the extension of 4 weeks because of delayed response evaluation, recovery toxicities of chemotherapy, and official process including agree with informed consent. Recently, ongoing studies about maintenance therapy in lymphoma have window periods of 8-12 weeks.
Ixazomib maintenance should continue for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Ixazomib 3mg on day 1, 8, 15 q 4 weeks for 24months or untile to progression
| Arm | Type | Receives |
|---|---|---|
| Ixazomib | Experimental | Drug: IxazomibIxazomib 3mg on day a, 8, 15 q 4 weeks for 24 months or until to progression |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female patients aged ≥19 years
- Histologically confirmed mantle cell lymphoma (MCL) meeting the following criteria: determined by histology and either expression of cyclin D1 (in association with CD20 and CD5) or evidence of t(11;14) translocation (by cytogenetics, fluorescence in-situ hybridization, or polymerase chain reaction)
- In all patients, a paraffin-embedded biopsy tissue block or slides (preferably of lymph node origin or bone marrow) was sent to central laboratories (Diagnostic Cytology Laboratories or department of pathology) for confirmation of diagnosis of MCL.
- Stage II, III, or IV
- Patients who received RCHOP or VR-CAP induction chemotherapy for 6 cycles confirmed response as more than PR or PR after induction therapy and who are ineligible for transplantation. .
Key exclusion criteria (16 listed)
- Female patients who are lactating or have a positive serum pregnancy test during the screening period.
- Grade 2 or higher baseline peripheral neuropathy
- Major surgery within 14 days before enrollment.
- Radiotherapy within 14 days before enrollment. If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib.
- Central nervous system involvement.
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 |
|---|---|---|
| IxazomibIxazomib 3mg on day 1, 8, 15 q 4 weeks for 24 months or until progression | Drug | Ixazomib |
Primary outcome
2-year PFS rates in adult patients with newly diagnosed Mantle Cell Lymphoma
Time frame: 2years
6 secondary outcomes
Complete Response (CR) achievement rates after ixazomib maintenance by Lugano classification
Time frame: an average of 2 year
Overall survival (OS) rates at 2 years
Time frame: 2years
Adverse events (AEs)
Time frame: 2years
Time to relapse/progression
Time frame: 2years
Time to next therapy (TTNT)
Time frame: 2years
Minimal residual disease (MRD) by IgH or IgK NGS from BM, lymphoma tissue at the baseline and then peripheral blood (cell free DNA).
Time frame: Screening, 24weeks, 4weeks after end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
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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.
Ho Sup Lee, MD principal investigator
Kosin University Gospel Hospital
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 Mantle Cell Lymphoma, run by Ho Sup Lee at 1 site in South Korea.
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 14 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 6 Oct 2023. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ho Sup Lee, MD (82-51-990-6363, hs3667@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year PFS rates in adult patients with newly diagnosed Mantle Cell Lymphoma (time frame: 2years). 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 6 Oct 2023.