LymphomaPhase 2NCT02272686
Ibrutinib Post Stem Cell Transplantation (SCT) in Double-Hit B-Cell Lymphoma
A Phase 2 study testing Ibrutinib in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if ibrutinib can help to control lymphoma in patients who have had an autologous stem cell transplant (a transplant using your own stem cells). The safety of this drug will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Ibrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2016to 22 Dec 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients with newly diagnosed double hit in first complete remission, anytime during the first 3 months after chemoimmunotherapy followed by autologous stem cell transplantation if there was no evidence of progression.
- Double hit lymphoma is defined as B-cell lymphoma with genetic abnormalities involving A) and in addition, B) and/or C): A) C-MYC arrangement or amplification by FISH study. B) BCL2 rearrangement or amplification by FISH study. C) BCL6 rearrangement or amplification by FISH study.
- ANC >/= 1,000, platelets >/= 75,000.
- AST and/or ALT < 3 times the ULN.
- Creatinine clearance > 30 ml/min (Cockcroft-Gault formula using ideal body weight).
- Male or female age >/= 18 years.
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- ECOG performance status </= 2.
- Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information.
- Patient should preferably have received a pre-transplant conditioning with rituximab and Carmustine/Etoposide/Cytarabine/Melphalan/Rituxan (BEAM/R) . Other regimens which are similar may be accepted at the discretion of the PI.
Who cannot join
- Prior chemotherapy within 3 weeks, nitrosoureas (carmustine) within 6 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy within 3 weeks, or major surgery within 2 weeks of first dose of study drug.
- Relapsed within three months post transplant.
- History of other malignancies within the past year except for treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- Known CNS lymphoma.
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification.
- Requires treatment with a strong cytochrome P450 (CYP)3A inhibitor (i.e. Voriconazole, posaconazole, itraconazole, clarithromycin, etc.) or inducer (carbamazepine, rifampin, phenytoin, etc.).
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- AST and/or ALT >/= 3 times the ULN.
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or symptomatic ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
- Known history of human immunodeficiency virus or active infection with hepatitis C virus or hepatitis B virus or any uncontrolled active systemic infection.
- Positive pregnancy test in women of childbearing potential.
- Lactating or pregnant or will not agree to use contraception during the study and for 30 days after the last dose of study drug if sexually active and able to bear children.
- Concomitant use of warfarin or other Vitamin K antagonists.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Targeting Bruton's Tyrosine Kinase (BTK) With Ibrutinib After Autologous Stem Cell Transplantation in "Double-Hit" B-Cell Lymphoma
The goal of this clinical research study is to learn if ibrutinib can help to control lymphoma in patients who have had an autologous stem cell transplant (a transplant using your own stem cells). The safety of this drug will also be studied.
Read the detailed description
Study Drug Administration:
If you take part in this study, you will take ibrutinib by mouth 1 time each day for up to 3 years. You must swallow the capsules whole with a glass (about 8 ounces) of water. Do not open, break, or chew the capsules. You should take ibrutinib at the same time every day.
If you miss a dose of ibrutinib, take it as soon as you remember on the same day. Take your next dose of ibrutinib at your regular time on the next day. Do not take 2 doses of ibrutinib on the same day to make up for a missed dose.
You will be given a study drug diary to write down what time you take each dose of ibrutinib. You need to bring the study drug diary, any leftover study drug, and any empty study drug containers with you to each visit.
The dose of ibrutinib you receive may be lowered, if the doctor thinks it is needed.
Study Visits:
One (1) time during Weeks 1-4, 6, and 8 and then 1 time each month after that for up to 3 years after your first dose of ibrutinib, blood (about 2 tablespoons) will be drawn for routine tests and to check your kidney and liver function. The blood draws may be performed at MD Anderson or at a lab closer to your home.
If the study doctor thinks it is needed, you may need to have these blood draws more often.
Around 1 month after your first dose of ibrutinib, you will have a bone marrow biopsy/aspirate to check the status of the disease, if the study doctor thinks it is needed. To collect a bone marrow biopsy/aspirate, an area of the hip or other site is numbed with anesthetic, and a small amount of bone and bone marrow is withdrawn through a large needle.
Around 3, 6, 9, and 12 months, then every 6 months for 3 years after your first dose of ibrutinib:
- You will have a physical exam.
- You will have computed tomography (CT) scans to check the status of the disease.
- You will have a bone marrow biopsy/aspirate to check the status of the disease.
Length of Study:
You may continue taking the study drug for up to 3 years. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on this study will be over after about 3 years.
Follow-Up Visit:
You will continue to have the CT scans and blood draws described in the study visits section 1 time a year for up to 3 years.
If you had a positron emission tomography (PET) scan that was performed at the time of your transplant and the scan showed that the disease was still in your body, you will have a PET scan 1 time each year while taking ibrutinib. The PET scan will not be repeated if the results show that there is no disease in the body.
This is an investigational study. Ibrutinib is FDA-approved and commercially available for the treatment of many types of cancers, including mantle cell lymphoma with 1 prior therapy. The use of ibrutinib to treat double hit lymphoma after an autologous stem cell transplant is considered investigational. The study doctor can explain how the study drug is designed to work.
Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbrutinibDrug
Also called PCI-32765, Imbruvica
560 mg by mouth daily.
| Study group | Role | What they receive |
|---|---|---|
| Ibrutinib | Experimental | Ibrutinib started at a daily dose of 560 mg by mouth daily for up to 3 years. Receives: Drug: Ibrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival (DFS)
Participants will be assessed for disease status and survival.
Measured: Two years
Secondary outcomes (1)
Overall Survival (OS)
Participants will be assessed at 3 year time point for survival.
Measured: Three Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study start3 Jun 2016
- Primary completion22 Dec 2017
- Study completion22 Dec 2017
Why it stopped: Slow Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmacyclics LLC.
- Responsible party
- Sponsor
- Investigators
- Issa F. Khouri, MD, BS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272686
- Sponsor's protocol ID
- 2014-0096
- Other IDs
- NCI-2015-00843
- Status last verified
- Nov 2018
- First submitted
- 21 Oct 2014
- Last updated
- 5 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Bruton's Tyrosine Kinase (BTK) With Ibrutinib After Autologous Stem Cell Transplantation in "Double-Hit" B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT02272686
- Acronym / sponsor ID
- 2014-0096
- Conditions
- Lymphoma
- Keywords
- Lymphoma, Blood And Marrow Transplantation, Post Autologous Stem Cell Transplantation, SCT, B-cell lymphoma, Ibrutinib, PCI-32765, Imbruvica
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Pharmacyclics LLC.
- Study start
- 3 Jun 2016 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 23 Oct 2014 (estimated)
- Results
- Posted 5 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if ibrutinib can help to control lymphoma in patients who have had an autologous stem cell transplant (a transplant using your own stem cells). The safety of this drug will also be studied.
Detailed description
Study Drug Administration:
If you take part in this study, you will take ibrutinib by mouth 1 time each day for up to 3 years. You must swallow the capsules whole with a glass (about 8 ounces) of water. Do not open, break, or chew the capsules. You should take ibrutinib at the same time every day.
If you miss a dose of ibrutinib, take it as soon as you remember on the same day. Take your next dose of ibrutinib at your regular time on the next day. Do not take 2 doses of ibrutinib on the same day to make up for a missed dose.
You will be given a study drug diary to write down what time you take each dose of ibrutinib. You need to bring the study drug diary, any leftover study drug, and any empty study drug containers with you to each visit.
The dose of ibrutinib you receive may be lowered, if the doctor thinks it is needed.
Study Visits:
One (1) time during Weeks 1-4, 6, and 8 and then 1 time each month after that for up to 3 years after your first dose of ibrutinib, blood (about 2 tablespoons) will be drawn for routine tests and to check your kidney and liver function. The blood draws may be performed at MD Anderson or at a lab closer to your home.
If the study doctor thinks it is needed, you may need to have these blood draws more often.
Around 1 month after your first dose of ibrutinib, you will have a bone marrow biopsy/aspirate to check the status of the disease, if the study doctor thinks it is needed. To collect a bone marrow biopsy/aspirate, an area of the hip or other site is numbed with anesthetic, and a small amount of bone and bone marrow is withdrawn through a large needle.
Around 3, 6, 9, and 12 months, then every 6 months for 3 years after your first dose of ibrutinib:
- You will have a physical exam.
- You will have computed tomography (CT) scans to check the status of the disease.
- You will have a bone marrow biopsy/aspirate to check the status of the disease.
Length of Study:
You may continue taking the study drug for up to 3 years. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on this study will be over after about 3 years.
Follow-Up Visit:
You will continue to have the CT scans and blood draws described in the study visits section 1 time a year for up to 3 years.
If you had a positron emission tomography (PET) scan that was performed at the time of your transplant and the scan showed that the disease was still in your body, you will have a PET scan 1 time each year while taking ibrutinib. The PET scan will not be repeated if the results show that there is no disease in the body.
This is an investigational study. Ibrutinib is FDA-approved and commercially available for the treatment of many types of cancers, including mantle cell lymphoma with 1 prior therapy. The use of ibrutinib to treat double hit lymphoma after an autologous stem cell transplant is considered investigational. The study doctor can explain how the study drug is designed to work.
Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ibrutinib | Experimental | Drug: IbrutinibIbrutinib started at a daily dose of 560 mg by mouth daily for up to 3 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with newly diagnosed double hit in first complete remission, anytime during the first 3 months after chemoimmunotherapy followed by autologous stem cell transplantation if there was no evidence of progression.
- Double hit lymphoma is defined as B-cell lymphoma with genetic abnormalities involving A) and in addition, B) and/or C): A) C-MYC arrangement or amplification by FISH study. B) BCL2 rearrangement or amplification by FISH study. C) BCL6 rearrangement or amplification by FISH study.
- ANC >/= 1,000, platelets >/= 75,000.
- AST and/or ALT < 3 times the ULN.
- Creatinine clearance > 30 ml/min (Cockcroft-Gault formula using ideal body weight).
Key exclusion criteria (12 listed)
- Prior chemotherapy within 3 weeks, nitrosoureas (carmustine) within 6 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy within 3 weeks, or major surgery within 2 weeks of first dose of study drug.
- Relapsed within three months post transplant.
- History of other malignancies within the past year except for treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- Known CNS lymphoma.
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification.
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 |
|---|---|---|
| IbrutinibAlso: PCI-32765, Imbruvica560 mg by mouth daily. | Drug | Ibrutinib |
Primary outcome
Disease Free Survival (DFS)
Time frame: Two years
Participants will be assessed for disease status and survival.
1 secondary outcome
Overall Survival (OS)
Time frame: Three Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Issa F. Khouri, MD, BS principal investigator
M.D. Anderson 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 2 study testing Ibrutinib in people with Lymphoma, run by M.D. Anderson Cancer Center 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 10 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: stopped early, as of the sponsor's last update on 5 Dec 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 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?
Yes. Results are posted in the registry (first posted 5 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Disease Free Survival (DFS) (time frame: Two years). 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 5 Dec 2018.