Diffuse Large B-Cell Lymphoma RefractoryPhase 2NCT03367143
Lenalidomide Plus ICE in the Treatment of Refractory and Relapsed DLBCL
A Phase 2 study testing Lenalidomide, Ifosfamide and Carboplatin in people with Diffuse Large B-Cell Lymphoma Refractory, run by Ruijin Hospital at 1 site in China.
Trial summary
This study is to evaluate the efficacy and safety of Lenalidomide plus ICE in the treatment of Refractory and Relapsed DLBCL patients. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma Refractory
- What is being tested?
- Lenalidomide, Ifosfamide and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Dec 2020
- 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically proven diffuse large B-cell lymphoma. Previously treated with 1, and only 1, chemotherapy regimen including rituximab and anthracycline. Relapse after CR, less than PR or PR to previous treatment.
- No history of stem cell transplantation.
- Age between 16-75.
- ECOG<3.
- At least 1 measurable tumor mass.
- Minimum life expectancy of 3 months.
Show all 9Show fewer
- Written informed consent.
- No history of using Lenalidomide, ifosfamide, carboplatin and etoposide.
- No uncontrolled CNS involvement by lymphoma:No CNS disease at time of relapse;CNS disease diagnosed at initial presentation allowed provided a complete response for CNS disease was achieved and maintained.
Who cannot join
- Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study.
- Clinically significant active infection.
- Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule.
- Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.
- Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment.
- Patients who are pregnant or breast-feeding.
- HIV infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of the Efficacy and Safety of Lenalidomide Plus ICE in the Treatment of Refractory and Relapsed Diffuse Large B-cell Lymphoma
This study is to evaluate the efficacy and safety of Lenalidomide plus ICE in the treatment of Refractory and Relapsed DLBCL patients.
- Conditions
- Diffuse Large B-Cell Lymphoma Refractory
- Being tested
- Lenalidomide, Ifosfamide, Carboplatin, Etoposide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
IfosfamideDrug
CarboplatinDrug
EtoposideDrug
| Study group | Role | What they receive |
|---|---|---|
| L-ICE | Experimental | Lenalidomide 25mg/d po d1-10, Ifosfamide 1500mg/m2/d iv d1-3, Carboplatin 5*[GFR(ml/min)+25]mg/d iv d2, Etoposide 100mg/m2/d iv d1-3, Frequency every 21 days, Total cycles 4 Receives: Drug: Lenalidomide; Drug: Ifosfamide; Drug: Carboplatin; Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
Measured: 12 weeks
Secondary outcomes (4)
Progression free survival rate
Measured: 1 year
Overall survival rate
Measured: 1 year
Overall response rate
Measured: 12 weeks
Safety as assessed using CTCAE v4.0
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 posted8 Dec 2017
- Study startDec 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (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 Lymphoma RefractoryStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
- Investigators
- Weili Zhao, MD, PhD, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367143
- Sponsor's protocol ID
- L-ICE
- Status last verified
- Mar 2020
- First submitted
- 10 Nov 2017
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of the Efficacy and Safety of Lenalidomide Plus ICE in the Treatment of Refractory and Relapsed Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT03367143
- Acronym / sponsor ID
- L-ICE
- Conditions
- Diffuse Large B-Cell Lymphoma Refractory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 8 Dec 2017 (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 study is to evaluate the efficacy and safety of Lenalidomide plus ICE in the treatment of Refractory and Relapsed DLBCL patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| L-ICE | Experimental | Drug: Lenalidomide, Drug: Ifosfamide, Drug: Carboplatin, Drug: EtoposideLenalidomide 25mg/d po d1-10, Ifosfamide 1500mg/m2/d iv d1-3, Carboplatin 5*[GFR(ml/min)+25]mg/d iv d2, Etoposide 100mg/m2/d iv d1-3, Frequency every 21 days, Total cycles 4 |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically proven diffuse large B-cell lymphoma. Previously treated with 1, and only 1, chemotherapy regimen including rituximab and anthracycline. Relapse after CR, less than PR or PR to previous treatment.
- No history of stem cell transplantation.
- Age between 16-75.
- ECOG<3.
- At least 1 measurable tumor mass.
Key exclusion criteria (7 listed)
- Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study.
- Clinically significant active infection.
- Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule.
- Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.
- Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment.
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 |
|---|---|---|
| Lenalidomide | Drug | L-ICE |
| Ifosfamide | Drug | L-ICE |
| Carboplatin | Drug | L-ICE |
| Etoposide | Drug | L-ICE |
Primary outcome
Complete response rate
Time frame: 12 weeks
4 secondary outcomes
Progression free survival rate
Time frame: 1 year
Overall survival rate
Time frame: 1 year
Overall response rate
Time frame: 12 weeks
Safety as assessed using CTCAE v4.0
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Diffuse Large B-Cell Lymphoma Refractory
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
RecruitingPhase 2
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements, Recurrent Diffuse Large B-Cell Lymphoma
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
RecruitingPhase 1/2
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
Lymphoma, Non-Hodgkin Lymphoma
Not yet recruitingPhase 2/3
A Clinical Trial of MK-1045 With Zilovertamab Vedotin in Participants With Diffuse Large B-cell Lymphoma (MK-1045-010)
Lymphoma, Large B-Cell, Diffuse, Diffuse Large B-Cell Lymphoma
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.
Weili Zhao, MD, PhD principal investigator
Shanghai Jiao Tong University School of Medicine
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 Lenalidomide, Ifosfamide and Carboplatin in people with Diffuse Large B-Cell Lymphoma Refractory, run by Ruijin 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 7 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 Mar 2020. 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?
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?
Complete response rate (time frame: 12 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 11 Mar 2020.