Chronic Lymphocytic LeukemiaPhase 1NCT02200848
Phase I Study of Lenalidomide, Rituximab and Ibrutinib in Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)
A Phase 1 study testing Lenalidomide, Ibrutinib, Rituximab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Georgetown University at 1 site in United States.
Trial summary
This study is for subjects diagnosed with recurrent or relapsed CLL/SLL. The purpose of this study is to test the safety of the combination of the drugs lenalidomide and ibrutinib at different dose levels, in combination with the drug rituximab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- What is being tested?
- Lenalidomide, Ibrutinib, Rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 1 Aug 2017
- Phase
- Phase 1
- 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
- Previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma that requires treatment
- No prior systemic treatment within 4 weeks of enrollment
- No corticosteroids within 2 weeks prior to study entry
- Measurable disease must be present
- No concomitant anti-cancer therapies
- ECOG status </= 2
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- Patients with HIV infection are eligible
- Patients with treated CLL or SLL in CNS are eligible
- Non-pregnant and non-nursing
- Life expectancy greater than 60 days
- Adequate bone marrow, kidney and liver function
- No major surgery within 28 days or minor surgery within 5 days of starting treatment
Who cannot join
- History od Richter's transformation
- History of prior allogeneic transplant
- Radioimmunotherapy within 1 year of enrollment
- Prior Bruton's tyrosine kinase inhibitor or lenalidomide
- History of allergic reactions to compounds similar to ibrutinib, lenalidomide or rituximab or hypersensitivity
- active or uncontrolled autoimmune hemolytic anemia or ITP
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- Transfusion-dependent thrombocytopenia or bleeding disorders
- Active hepatitis B or C infections
- History of known Human Anti-Chimeric Antibody positivity
- History of erythema multiforme, toxic epidermal necrolysis, or Stevens-Johnson syndrome
- History of uncontrolled seizures
- Autoimmune disorder that requires active immunosuppression
- Stroke or intracranial hemorrhage within last 6 months
- History of congestive heart failure, myocardial infarction, unstable angina, uncontrolled arrhythmia or any Class 3 or 4 heart disease in the last 6 months
- No prior malignancy except if treated with curative intent with no active disease for more than 3 years; adequately treated non-melanoma skin cancer or cervical cancer in situ
- using warfarin or similar Vitamin K antagonists Unable to swallow capsules or disease significantly affecting gastrointestinal function or inhibiting small intestine absorption
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007
About this study
Official title: A Phase I Study of Lenalidomide in Combination With Rituximab and Ibrutinib in Relapsed and Refractory CLL and SLL
This study is for subjects diagnosed with recurrent or relapsed CLL/SLL. The purpose of this study is to test the safety of the combination of the drugs lenalidomide and ibrutinib at different dose levels, in combination with the drug rituximab. We want to find out what effects, good and/or bad, they have on patients with CLL/SLL.
The hypothesis of the study is that it will be safe to give the three drugs in combination and the information learned from this trial will be used to study the 3 drug combination is a larger future trial.
Read the detailed description
Treatment consists of dose escalations of lenalidomide and ibrutinib and fixed doses of rituximab. A small expansion cohort to include 10 patients will follow once the recommended phase II dose is found.
- Being tested
- Lenalidomide, Ibrutinib, Rituximab
- Keywords
- Lenalidomide, Ibrutinib, Rituximab, CLL, SLL
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenalidomide, Ibrutinib, RituximabDrug
Also called Ibrutinib, PCI-32765, NSC# 748645, Imbruvica
Dose level -2 Ibrutinib 280 mg; Lenalidomide 2.5 mg; Rituximab 375 mg/m2 Level -1 Ibrutinib 420 mg; Lenalidomide 2.5 mg; Rituximab 375 mg/m2 Level 1 Ibrutinib 420 mg; Lenalidomide 5 mg; Rituximab 375 mg/m2 Level 2 Ibrutinib 420 mg; Lenalidomide 10 mg; Rituximab 375 mg/m2 Level 3 Ibrutinib 420 mg; Lenalidomide 15 mg; Rituximab 375 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide, Ibrutinib, Rituximab | Experimental | Rituximab on day 1, lenalidomide days 1-21 and ibrutinib continuously for 6 cycles or until disease progression or intolerance to the combination. Single agent ibrutinib will then be continued until disease progression or intolerance. Receives: Drug: Lenalidomide, Ibrutinib, Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase II dose
The dose at which less than 2 of 6 patients experience a dose limiting toxicity
Measured: 1year
Secondary outcomes (2)
Safety
adverse events, serious adverse events, adverse events leading to discontinuation, deaths
Measured: 2 years
Antitumor efficacy
Proportion of patients who achieve stable disease, partial or complete response; progression-free survival defined as duration of time from start of treatment to time of progression or death
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 posted25 Jul 2014 (estimated)
- Study startApr 2014
- Primary completion27 Mar 2017
- Study completion1 Aug 2017
Why it stopped: Recruitment difficulties and toxicity
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Chaitra Ujjani, MD, Principal investigator, Georgetown Lombardi Comprehsnive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200848
- Sponsor's protocol ID
- NCI#9540
- Status last verified
- May 2017
- First submitted
- 22 Jul 2014
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ujjani C, Wang H, Skarbnik A, Trivedi N, Ramzi P, Khan N, Cheson BD. A phase 1 study of lenalidomide and ibrutinib in combination with rituximab in relapsed and refractory CLL. Blood Adv. 2018 Apr 10;2(7):762-768. doi: 10.1182/bloodadvances.2017015263.
PubMed 29610115
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Lenalidomide in Combination With Rituximab and Ibrutinib in Relapsed and Refractory CLL and SLL
- ClinicalTrials.gov ID
- NCT02200848
- Acronym / sponsor ID
- NCI#9540
- Keywords
- Lenalidomide, Ibrutinib, Rituximab, CLL, SLL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties and toxicity
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2014
- Primary completion
- 27 Mar 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 25 Jul 2014 (estimated)
- 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 for subjects diagnosed with recurrent or relapsed CLL/SLL. The purpose of this study is to test the safety of the combination of the drugs lenalidomide and ibrutinib at different dose levels, in combination with the drug rituximab. We want to find out what effects, good and/or bad, they have on patients with CLL/SLL.
The hypothesis of the study is that it will be safe to give the three drugs in combination and the information learned from this trial will be used to study the 3 drug combination is a larger future trial.
Detailed description
Treatment consists of dose escalations of lenalidomide and ibrutinib and fixed doses of rituximab. A small expansion cohort to include 10 patients will follow once the recommended phase II dose is found.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide, Ibrutinib, Rituximab | Experimental | Drug: Lenalidomide, Ibrutinib, RituximabRituximab on day 1, lenalidomide days 1-21 and ibrutinib continuously for 6 cycles or until disease progression or intolerance to the combination. Single agent ibrutinib will then be continued until disease progression or intolerance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma that requires treatment
- No prior systemic treatment within 4 weeks of enrollment
- No corticosteroids within 2 weeks prior to study entry
- Measurable disease must be present
- No concomitant anti-cancer therapies
Key exclusion criteria (16 listed)
- History od Richter's transformation
- History of prior allogeneic transplant
- Radioimmunotherapy within 1 year of enrollment
- Prior Bruton's tyrosine kinase inhibitor or lenalidomide
- History of allergic reactions to compounds similar to ibrutinib, lenalidomide or rituximab or hypersensitivity
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, Ibrutinib, RituximabAlso: Ibrutinib, PCI-32765, NSC# 748645, ImbruvicaDose level -2 Ibrutinib 280 mg; Lenalidomide 2.5 mg; Rituximab 375 mg/m2 Level -1 Ibrutinib 420 mg; Lenalidomide 2.5 mg; Rituximab 375 mg/m2 Level 1 Ibrutinib 420 mg; Lenalidomide 5 mg; Rituximab 375 mg/m2 Level 2 Ibrutinib 420 mg; Lenalidomide 10 mg; Rituximab 375 mg/m2 Level 3 Ibrutinib 420 mg; Lenalidomide 15 mg; Rituximab 375 mg/m2 | Drug | Lenalidomide, Ibrutinib, Rituximab |
Primary outcome
Recommended Phase II dose
Time frame: 1year
The dose at which less than 2 of 6 patients experience a dose limiting toxicity
2 secondary outcomes
Safety
Time frame: 2 years
Antitumor efficacy
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Recruitment difficulties and toxicity). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
- Derived from this study: PubMed 29610115Ujjani C, Wang H, Skarbnik A, Trivedi N, Ramzi P, Khan N, Cheson BD. A phase 1 study of lenalidomide and ibrutinib in combination with rituximab in relapsed and refractory CLL. Blood Adv. 2018 Apr 10;2(7):762-768. doi: 10.1182/bloodadvances.2017015263.
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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.
Chaitra Ujjani, MD principal investigator
Georgetown Lombardi Comprehsnive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lenalidomide, Ibrutinib, Rituximab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Georgetown University at 1 site in United States.
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 12 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: stopped early, as of the sponsor's last update on 12 Jan 2018. 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 United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment difficulties and toxicity). 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?
Recommended Phase II dose (time frame: 1year). 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 NCT02200848, which also lists 1 linked publication.
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 12 Jan 2018.