Diffuse Large B-cell LymphomaPhase 2NCT04827004
A Study of Anlotinib Hydrochloride Capsules in Subjects With Diffuse Large B-Cell Lymphoma
A Phase 2 study testing Anlotinib Hydrochloride Capsules in people with Diffuse Large B-cell Lymphoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This is an open-label, single-center, single-arm study to evaluate the efficacy and safety of Anlotinib Hydrochloride Capsules in subjects with diffuse large B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- What is being tested?
- Anlotinib Hydrochloride Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Apr 2021to 31 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. ≥18 years old; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, life expectancy≥ 12 weeks.
- 2. Histopathologically confirmed diffuse large B-cell lymphoma (DLBCL) . 3. Has received at least 2 lines of systemic treatment. 4. At least one measurable lesion in vertical directions(based on Lugano 2014). 5.Adequate organ system function. 6. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ; No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.
- 7. Understood and signed an informed consent form.
Who cannot join
- 1. DLBCL transformed from indolent lymphoma (such as FL), primary testicular DLBCL, primary central nervous system lymphoma, mixed lymphoma (such as B cell lymphoma that cannot be classified between HL and DLBCL) Tumor, etc.), Richter's transformed DLBCL.
- 2. Has central nervous system (CNS) invasion. 3. Has received vascular endothelial growth inhibitor, such as sunitinib, sorafenib, pazopanib, imatinib, famitinib, apatinib, anlotinib and so on.
- 4. Has other malignancies (except cured skin basal cell carcinoma and cervical carcinoma in situ) within 3 years.
- 5. Has a history of immunodeficiency. 6. Has multiple factors affecting oral medication. 7.Has uncontrollable or important cardiovascular disease. 8.Has any severe and/or uncontrolled diseases. 9. Has received surgery, or unhealed wounds within 4 weeks before the first administration.
- 10. Has received systemic steroid therapy within 7 days before the first administration.
- 11. Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear.
Show all 12Show fewer
- 12. Has any bleeding symptoms or treated with anticoagulants or vitamin K antagonists.
- 13. Has arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident including transient ischemic attack, deep vein thrombosis and pulmonary embolism.
- 14. Has psychotropic substances abuse or a mental disorder. 15. Has received autologous hematopoietic stem cell transplantation within 3 months before the first administration, or have received allogeneic hematopoietic stem cell transplantation, or have graft-versus-host reaction.
- 16. Has received other anti-tumor therapy within 4 weeks before the first administration.
- 17.According to the judgement of the researchers, there are other factors that may lead to the termination of the study.
- 18. Unsuitable for anlotinib hydrochloride.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Yuankai Shi, Doctor, 010-87788268, syuankaipumc@126.com
Yuankai Shi, Doctor
About this study
Official title: A Open-label, Single-center, Single-arm Phase II Study of Anlotinib Hydrochloride Capsules in Subjects With Diffuse Large B-Cell Lymphoma
This is an open-label, single-center, single-arm study to evaluate the efficacy and safety of Anlotinib Hydrochloride Capsules in subjects with diffuse large B-cell lymphoma.
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- Anlotinib Hydrochloride Capsules
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib Hydrochloride CapsulesDrug
Anlotinib capsules given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib Hydrochloride Capsules | Experimental | This is a multi-target receptor tyrosine kinase inhibitor. Receives: Drug: Anlotinib Hydrochloride Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Percentage of participants achieving complete response (CR) and partial response (PR).
Measured: up to 48 weeks
Secondary outcomes (3)
Progression-free survival (PFS)
PFS defined as the time from first medication until the first documented progressive disease (PD) or death from any cause.
Measured: up to 48 weeks
Overall survival (OS)
OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.
Measured: up to 48 weeks
Duration of Response (DOR)
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Measured: up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study startApr 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827004
- Sponsor's protocol ID
- ALTN-20-II
- Status last verified
- Jul 2020
- First submitted
- 30 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Open-label, Single-center, Single-arm Phase II Study of Anlotinib Hydrochloride Capsules in Subjects With Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT04827004
- Acronym / sponsor ID
- ALTN-20-II
- Conditions
- Diffuse Large B-cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 1 Apr 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 an open-label, single-center, single-arm study to evaluate the efficacy and safety of Anlotinib Hydrochloride Capsules in subjects with diffuse large B-cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anlotinib Hydrochloride Capsules | Experimental | Drug: Anlotinib Hydrochloride CapsulesThis is a multi-target receptor tyrosine kinase inhibitor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. ≥18 years old; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, life expectancy≥ 12 weeks.
- 2. Histopathologically confirmed diffuse large B-cell lymphoma (DLBCL) . 3. Has received at least 2 lines of systemic treatment. 4. At least one measurable lesion in vertical directions(based on Lugano 2014). 5.Adequate organ system function. 6. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ; No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.
- 7. Understood and signed an informed consent form.
Key exclusion criteria (12 listed)
- 1. DLBCL transformed from indolent lymphoma (such as FL), primary testicular DLBCL, primary central nervous system lymphoma, mixed lymphoma (such as B cell lymphoma that cannot be classified between HL and DLBCL) Tumor, etc.), Richter's transformed DLBCL.
- 2. Has central nervous system (CNS) invasion. 3. Has received vascular endothelial growth inhibitor, such as sunitinib, sorafenib, pazopanib, imatinib, famitinib, apatinib, anlotinib and so on.
- 4. Has other malignancies (except cured skin basal cell carcinoma and cervical carcinoma in situ) within 3 years.
- 5. Has a history of immunodeficiency. 6. Has multiple factors affecting oral medication. 7.Has uncontrollable or important cardiovascular disease. 8.Has any severe and/or uncontrolled diseases. 9. Has received surgery, or unhealed wounds within 4 weeks before the first administration.
- 10. Has received systemic steroid therapy within 7 days before the first administration.
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 |
|---|---|---|
| Anlotinib Hydrochloride CapsulesAnlotinib capsules given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21). | Drug | Anlotinib Hydrochloride Capsules |
Primary outcome
Overall response rate (ORR)
Time frame: up to 48 weeks
Percentage of participants achieving complete response (CR) and partial response (PR).
3 secondary outcomes
Progression-free survival (PFS)
Time frame: up to 48 weeks
Overall survival (OS)
Time frame: up to 48 weeks
Duration of Response (DOR)
Time frame: up to 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
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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.
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 Anlotinib Hydrochloride Capsules in people with Diffuse Large B-cell Lymphoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. 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 3 inclusion and 12 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 1 Apr 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 Yuankai Shi, Doctor (010-87788268, syuankaipumc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: up to 48 weeks). 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 1 Apr 2021.