Mantle Cell LymphomaPhase 2NCT05076097
A Study of OLR in First-line Treatment of Mantle Cell Lymphoma
A Phase 2 study testing Orelabrutinib in in combination of rituximab and lenalidomide(OLR) in people with Mantle Cell Lymphoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a single-arm, multicenter, open label phase II clinical study to evaluate the efficacy and safety of OLR in the treatment of initially treated mantle cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- Orelabrutinib in in combination of rituximab and lenalidomide(OLR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2021to 15 Oct 2023
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically confirmed mantle cell lymphoma with chromosomal translocation. All subjects must provide adequate archived or fresh tumor tissue samples for immunohistochemistry (IHC) testing.
- Age 18-70, both male and female.
- No previous systemic treatment for lymphoma.
- Have at least one measurable lesion. Measurable disease was defined as measurable tumor masses ≥1.5 cm in one or both dimensions and measurable spleen lesions.
- Eastern Oncology Collaboration group physical status score was 0-2.
- Adequate hematological function
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- Life expectancy >3 months.
- Have the ability to provide written informed consent and understand and comply with study requirements.
- Ability to adhere to research visit schedules and other protocol requirements
Who cannot join
- Histology conformed blastolytic mantle cell lymphoma and polymorphic mantle cell lymphoma.
- Patients with current or suspected central nervous system involvement and history of this disease
- Received Bruton's tyrosine kinase inhibitor treatment
- Receive lenalidomide treatment
- Received other anti-tumor treatments
- Major surgery within 4 weeks prior to screening.
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- Have a history of other active malignant diseases within 2 years prior to study entry,
- Systemic fungal, bacterial or viral infection with uncontrolled activity
- The following serological states are known for human immunodeficiency virus (HIV) infection or suggest the presence of active hepatitis B or C virus infection
- Clinically serious cardiovascular disease
- A history of severe hemorrhagic disorders, such as hemophilia A, hemophilia B, von willebrand disease, or A history of spontaneous bleeding requiring blood transfusion or other medical intervention.
- A history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months.
- A history of major cerebrovascular disease/event, including stroke or intracranial hemorrhage, in the 6 months prior to first administration of the study drug.
- Anticoagulant therapy with warfarin or an equivalent vitamin K antagonist or anticoagulant therapy is required within 7 days of initial use of the study drug.
- Pregnant or lactating women
- Hypersensitivity to any study drug
- The presence of any life-threatening disease, medical condition, or organ system dysfunction that the investigator considers to be likely to affect the safety of the subject or cause risk
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Insititute & Hospital
Tianjin, Tianjin Municipality, 300181
Huilai Zhang, PHD, 18622221228, 18526812877@163.com
About this study
Official title: A Prospective Phase II Clinical Study of Orelabrutinib in Combination With Lenalidomide and Rituximab (OLR) in First-line Treatment of Mantle Cell Lymphoma
This is a single-arm, multicenter, open label phase II clinical study to evaluate the efficacy and safety of OLR in the treatment of initially treated mantle cell lymphoma.
Read the detailed description
Patients initially treated with mantle cell lymphoma were screened for OLR regimen according to study admission criteria. The study will accept up to 24 cycles of treatment until disease progression or intolerable toxicity occurs and subjects voluntarily withdraw informed consent. Patients undergoing hematopoietic stem cell transplantation after complete remission may begin stem cell collection after induction therapy for at least 6 months. Twenty-nine patients are expected to be enrolled
- Conditions
- Mantle Cell Lymphoma
- Being tested
- Orelabrutinib in in combination of rituximab and lenalidomide(OLR)
- 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.
Orelabrutinib in in combination of rituximab and lenalidomide(OLR)Drug
Also called OLR Arm
Induction treatment phase: Orelabrutinib: 150mg QD D1-28; Lenalidomide: Cycle 1: 15mg QD D1-21, if no dose-limiting toxicity occurred in Cycle 1, cycle 2-6: 20mg QD D1-21; Cycle 1: 375 mg/m2 d1, 8,15,22; Cycle 3, 5: 375 mg/m2 D1 Maintenance treatment phase: Orelabrutinib: 150mg QD D1-28; Lenalidomide: cycle 7-24: 15mg QD D1-21; Cycle 7, 9, 11, 13, 15, 17, 19, 21, 23: 375 mg/m2 D1. 28 days for a cycle.
| Study group | Role | What they receive |
|---|---|---|
| Orelabtutinib in combination of rituximab and lenalidomide(OLR) Arm | Experimental | Induction phase of mantle cell L lymphoma: Orelabrutinib: 150mg QD D1-28; Lenalidomide: Cycle 1: 15mg QD D1-21, if no dose-limiting toxicity occurred in Cycle 1, cycle 2-6: 20mg QD D1-21; Cycle 1: 375 mg/m2 d1, 8,15,22; Cycle 3, 5: 375 mg/m2 D1 Maintenance treatment phase: Orelabrutinib: 150mg QD D1-28; Lenalidomide: cycle 7-24: 15mg QD D1-21; Cycle 7, 9, 11, 13, 15, 17, 19, 21, 23: 375 mg/m2 D1 Receives: Drug: Orelabrutinib in in combination of rituximab and lenalidomide(OLR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate
The proportion of patients receiving the treatment with complete remission
Measured: At the end of Cycle 6(each cycle is 28 days)
Secondary outcomes (4)
Objective Response Rate
The proportion of patients with response of PR and CR.
Measured: Approximately 2 years
Time to Response
Measured from the date of initiation of treatment to the time of response
Measured: Approximately 1 year
The Progression Free Survival Rate in 2 Years
The proportion of patients who didn't achieve disease progression or death in 2 years.
Measured: 2 Years
The Overall Survival Rate in 2 Years
The proportion of patients who didn't achieve death in 2 years
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start30 Sep 2021
- Primary completion15 Oct 2022 (estimated)
- Study completion15 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mantle Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huilai Zhang, PHD, Principal investigator, Director of Hematology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076097
- Sponsor's protocol ID
- TS024
- Status last verified
- Sep 2021
- First submitted
- 30 Sep 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual patient data will be shared with other researchers
Publications
2020 ASH, poster 2042
EHA 2020-Abstract S228
Al-Hamadani M, Habermann TM, Cerhan JR, Macon WR, Maurer MJ, Go RS. Non-Hodgkin lymphoma subtype distribution, geodemographic patterns, and survival in the US: A longitudinal analysis of the National Cancer Data Base from 1998 to 2011. Am J Hematol. 2015 Sep;90(9):790-5. doi: 10.1002/ajh.24086. Epub 2015 Jul 27.
PubMed 26096944
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Clinical Study of Orelabrutinib in Combination With Lenalidomide and Rituximab (OLR) in First-line Treatment of Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT05076097
- Acronym / sponsor ID
- TS024
- Conditions
- Mantle Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 15 Oct 2023 (estimated)
- First posted
- 13 Oct 2021 (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.
This is a single-arm, multicenter, open label phase II clinical study to evaluate the efficacy and safety of OLR in the treatment of initially treated mantle cell lymphoma.
Detailed description
Patients initially treated with mantle cell lymphoma were screened for OLR regimen according to study admission criteria. The study will accept up to 24 cycles of treatment until disease progression or intolerable toxicity occurs and subjects voluntarily withdraw informed consent. Patients undergoing hematopoietic stem cell transplantation after complete remission may begin stem cell collection after induction therapy for at least 6 months. Twenty-nine patients are expected to be enrolled
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orelabtutinib in combination of rituximab and lenalidomide(OLR) Arm | Experimental | Drug: Orelabrutinib in in combination of rituximab and lenalidomide(OLR)Induction phase of mantle cell L lymphoma: Orelabrutinib: 150mg QD D1-28; Lenalidomide: Cycle 1: 15mg QD D1-21, if no dose-limiting toxicity occurred in Cycle 1, cycle 2-6: 20mg QD D1-21; Cycle 1: 375 mg/m2 d1, 8,15,22; Cycle 3, 5: 375 mg/m2 D1 Maintenance treatment phase: Orelabrutinib: 150mg QD D1-28; Lenalidomide: cycle 7-24: 15mg QD D1-21; Cycle 7, 9, 11, 13, 15, 17, 19, 21, 23: 375 mg/m2 D1 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histopathologically confirmed mantle cell lymphoma with chromosomal translocation. All subjects must provide adequate archived or fresh tumor tissue samples for immunohistochemistry (IHC) testing.
- Age 18-70, both male and female.
- No previous systemic treatment for lymphoma.
- Have at least one measurable lesion. Measurable disease was defined as measurable tumor masses ≥1.5 cm in one or both dimensions and measurable spleen lesions.
- Eastern Oncology Collaboration group physical status score was 0-2.
Key exclusion criteria (17 listed)
- Histology conformed blastolytic mantle cell lymphoma and polymorphic mantle cell lymphoma.
- Patients with current or suspected central nervous system involvement and history of this disease
- Received Bruton's tyrosine kinase inhibitor treatment
- Receive lenalidomide treatment
- Received other anti-tumor treatments
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 |
|---|---|---|
| Orelabrutinib in in combination of rituximab and lenalidomide(OLR)Also: OLR ArmInduction treatment phase: Orelabrutinib: 150mg QD D1-28; Lenalidomide: Cycle 1: 15mg QD D1-21, if no dose-limiting toxicity occurred in Cycle 1, cycle 2-6: 20mg QD D1-21; Cycle 1: 375 mg/m2 d1, 8,15,22; Cycle 3, 5: 375 mg/m2 D1 Maintenance treatment phase: Orelabrutinib: 150mg QD D1-28; Lenalidomide: cycle 7-24: 15mg QD D1-21; Cycle 7, 9, 11, 13, 15, 17, 19, 21, 23: 375 mg/m2 D1. 28 days for a cycle. | Drug | Orelabtutinib in combination of rituximab and lenalidomide(OLR) Arm |
Primary outcome
Complete Response Rate
Time frame: At the end of Cycle 6(each cycle is 28 days)
The proportion of patients receiving the treatment with complete remission
4 secondary outcomes
Objective Response Rate
Time frame: Approximately 2 years
Time to Response
Time frame: Approximately 1 year
The Progression Free Survival Rate in 2 Years
Time frame: 2 Years
The Overall Survival Rate in 2 Years
Time frame: 2 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Background2020 ASH, poster 2042
- BackgroundEHA 2020-Abstract S228
- Results publication: PubMed 26096944Al-Hamadani M, Habermann TM, Cerhan JR, Macon WR, Maurer MJ, Go RS. Non-Hodgkin lymphoma subtype distribution, geodemographic patterns, and survival in the US: A longitudinal analysis of the National Cancer Data Base from 1998 to 2011. Am J Hematol. 2015 Sep;90(9):790-5. doi: 10.1002/ajh.24086. Epub 2015 Jul 27.
- Individual participant dataSharing planned: No. No individual patient data will be shared with other researchers
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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.
Huilai Zhang, PHD principal investigator
Director of Hematology Department
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 Orelabrutinib in in combination of rituximab and lenalidomide(OLR) in people with Mantle Cell Lymphoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
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 9 inclusion and 17 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 11 Nov 2021. 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 China. 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 Huilai Zhang, PHD (18622221228, 18526812877@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response Rate (time frame: At the end of Cycle 6(each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05076097, which also lists 3 linked publications.
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 11 Nov 2021.