Refractory Diffuse Large B-cell LymphomaPhase 1/2DLBLNCT04856137
A Phase I/II Study of Diffuse Large B-cell Lymphoma
A Phase 1/2 study testing Rituximab Paclitaxel Ruxolitinib in people with Refractory Diffuse Large B-cell Lymphoma, run by National Health Research Institutes, Taiwan.
Trial summary
For continuous variables, mean, median, minimum, and maximum will be used for the descriptive purpose. For categorical variables, frequency and percentage will be used for descriptive statistics. The variables of OS will be estimated by the Kaplan-Meier method. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Refractory Diffuse Large B-cell Lymphoma
- What is being tested?
- Rituximab Paclitaxel Ruxolitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 31 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with relapsed/refractory CD20+ diffuse large B-cell lymphoma.
- Age greater than 20 years and younger than 75 years old.
- Measurable disease
- Patients must have an ECOG performance status of less than or equal to 2.
- Patients must have recovered from toxic effects of all prior therapy before entering onto study.
- A treatment of drug-free interval of at least 3 weeks since the last dose of chemotherapy is required.
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- More than 4 weeks since prior radiotherapy is required.
- Adequate bone marrow function
- Adequate renal function with calculated glomerular filtration rate > 15 mL/min
- Patients must have adequate liver function
- All patients must sign a document of informed consent indicating their awareness of the investigational nature and the risks of the study.
Who cannot join
- Patients who have prior treatment with ruxolitinib or taxane for DLBCL.
- Pregnant or breast-feeding females.
- Active or uncontrolled infection.
- Life expectancy < 6 months
- Patients with brain or leptomeningeal metastases.
- Known hypersensitivity to ruxolitinib or paclitaxel
- Grade III peripheral neuropathy secondary to prior to therapy
- Second malignancy, except indolent cancers not on active anti-cancer therapy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I/II Study of Relapse/Refractory Diffuse Large B-cell Lymphoma
For continuous variables, mean, median, minimum, and maximum will be used for the descriptive purpose. For categorical variables, frequency and percentage will be used for descriptive statistics. The variables of OS will be estimated by the Kaplan-Meier method. Differences between groups will be calculated using the log-rank test for univariate analysis. Cox's proportional hazards model will be employed to test independent prognostic factors. All calculations will be performed using the Statistical Package of Social Sciences software, version 17.0 (SPSS, Inc., Chicago, IL, USA). The level of statistical significance will be set at 0.05 for all tests.
Read the detailed description
This is an open-label, single arm, prospective, multiple-center phase Ib/II study.
In phase Ib, a maximum of 18 patients will be enrolled in the dose-finding period to determine the RP2D, dependent on the toxicity of the study drugs. The response rates of salvage chemotherapy regimen in R/R DLBCL were reported to be within the range of 35-65%.3 Assuming that the response rate of traditional salvage therapy has an overall response rate of 35% (H0=0.35) and that our experimental regimen would increase it to 50% (H1=0.50), the estimated sample size according to the Simon's two-stage minimal design will be 49 in the second phase.1 Briefly, among the 31 patients recruited during the first stage, the response should be seen in at least 10 of the cases, the lowest threshold for the trial to be moved into the second stage of the phase II part. Furthermore, for the RPR regimen to be deemed effective, a response must be demonstrated in at least 21 of the whole 49 patients enrolled in the phase II period. This would achieve a power of 80%, with a two-sided type I error rate of 10%. An additional 7 patients will be recruited, for an estimated dropout rate of 10%.
- Conditions
- Refractory Diffuse Large B-cell Lymphoma
- Being tested
- Rituximab Paclitaxel Ruxolitinib
- 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.
Rituximab Paclitaxel RuxolitinibDrug
Also called G-CSF 1PC sc qd
Rituximab 375mg/m2 on D1 of each cycle Paclitaxel 200mg/m2 on D1 of each cycle Ruxolitinib continuously given (D1-21)
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | ruxolitinib, paclitaxel, and rituximab Receives: Drug: Rituximab Paclitaxel Ruxolitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
The tumor response will be assessed according to IWG Response Criteria.
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 posted23 Apr 2021
- Study start1 May 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Diffuse Large B-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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase Ib Dose Escalation All patients received: Rituximab 375mg/m2 on D1 of each cycle, and Paclitaxel 200mg/m2 on D1 of each cycle, plus, G-CSF 1PC sc qd, starting D7 until ANC recovery Ruxolitinib continuously given (D1-21) in the following dose schema Phase II Efficacy Study All patients received: Rituximab 375mg/m2 on D1 of each cycle, and Paclitaxel 200mg/m2 on D1 of each cycle, plus Ruxolitinib using RP2D daily on D1-21 G-CSF 1PC sc qd, starting D7 until ANC recovery Repeat every 21 days
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan, Chang Gung Memorial Hospital, China Medical University Hospital, Shin Kong Wu Huo-Shih Memorial Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856137
- Sponsor's protocol ID
- T1420
- Acronym
- DLBL
- Status last verified
- Mar 2021
- First submitted
- 26 Nov 2019
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Relapse/Refractory Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT04856137
- Acronym / sponsor ID
- DLBL / T1420
- Conditions
- Refractory Diffuse Large B-cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan, Chang Gung Memorial Hospital, China Medical University Hospital, Shin Kong Wu Huo-Shih Memorial Hospital
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 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.
For continuous variables, mean, median, minimum, and maximum will be used for the descriptive purpose. For categorical variables, frequency and percentage will be used for descriptive statistics. The variables of OS will be estimated by the Kaplan-Meier method. Differences between groups will be calculated using the log-rank test for univariate analysis. Cox's proportional hazards model will be employed to test independent prognostic factors. All calculations will be performed using the Statistical Package of Social Sciences software, version 17.0 (SPSS, Inc., Chicago, IL, USA). The level of statistical significance will be set at 0.05 for all tests.
Detailed description
This is an open-label, single arm, prospective, multiple-center phase Ib/II study.
In phase Ib, a maximum of 18 patients will be enrolled in the dose-finding period to determine the RP2D, dependent on the toxicity of the study drugs. The response rates of salvage chemotherapy regimen in R/R DLBCL were reported to be within the range of 35-65%.3 Assuming that the response rate of traditional salvage therapy has an overall response rate of 35% (H0=0.35) and that our experimental regimen would increase it to 50% (H1=0.50), the estimated sample size according to the Simon's two-stage minimal design will be 49 in the second phase.1 Briefly, among the 31 patients recruited during the first stage, the response should be seen in at least 10 of the cases, the lowest threshold for the trial to be moved into the second stage of the phase II part. Furthermore, for the RPR regimen to be deemed effective, a response must be demonstrated in at least 21 of the whole 49 patients enrolled in the phase II period. This would achieve a power of 80%, with a two-sided type I error rate of 10%. An additional 7 patients will be recruited, for an estimated dropout rate of 10%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase Ib Dose Escalation All patients received: Rituximab 375mg/m2 on D1 of each cycle, and Paclitaxel 200mg/m2 on D1 of each cycle, plus, G-CSF 1PC sc qd, starting D7 until ANC recovery Ruxolitinib continuously given (D1-21) in the following dose schema Phase II Efficacy Study All patients received: Rituximab 375mg/m2 on D1 of each cycle, and Paclitaxel 200mg/m2 on D1 of each cycle, plus Ruxolitinib using RP2D daily on D1-21 G-CSF 1PC sc qd, starting D7 until ANC recovery Repeat every 21 days
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Drug: Rituximab Paclitaxel Ruxolitinibruxolitinib, paclitaxel, and rituximab |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with relapsed/refractory CD20+ diffuse large B-cell lymphoma.
- Age greater than 20 years and younger than 75 years old.
- Measurable disease
- Patients must have an ECOG performance status of less than or equal to 2.
- Patients must have recovered from toxic effects of all prior therapy before entering onto study.
Key exclusion criteria (8 listed)
- Patients who have prior treatment with ruxolitinib or taxane for DLBCL.
- Pregnant or breast-feeding females.
- Active or uncontrolled infection.
- Life expectancy < 6 months
- Patients with brain or leptomeningeal metastases.
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 |
|---|---|---|
| Rituximab Paclitaxel RuxolitinibAlso: G-CSF 1PC sc qdRituximab 375mg/m2 on D1 of each cycle Paclitaxel 200mg/m2 on D1 of each cycle Ruxolitinib continuously given (D1-21) | Drug | single arm |
Primary outcome
Primary Outcome Measure
Time frame: 1 year
The tumor response will be assessed according to IWG Response Criteria.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Rituximab Paclitaxel Ruxolitinib in people with Refractory Diffuse Large B-cell Lymphoma, run by National Health Research Institutes, Taiwan.
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 11 inclusion and 8 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: opening soon, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chih-Cheng Chen, M.D. Ph.D. (886-5-3621000 ext. 2852, ccchen1968@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (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 23 Apr 2021.