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.
Terminated
Phase 2
NCT ID: NCT02272686
ORG ID: 2014-0096
NCI ID: NCI-2015-00843
Lymphoma
| Drug | Synonyms | Arms |
|---|---|---|
| Ibrutinib | PCI-32765, Imbruvica | Ibrutinib |
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. The safety of this
drug will also be studied.
Study Drug Administration:
If participant takes part in this study, they will take ibrutinib by mouth 1 time each day
for up to 3 years. Participant must swallow the capsules whole with a glass (about 8 ounces)
of water. Participant should not open, break, or chew the capsules. Participant should take
ibrutinib at the same time every day.
If participant misses a dose of ibrutinib, they should take it as soon as they remember on
the same day. Participant should take their next dose of ibrutinib at their regular time on
the next day. Participant should not take 2 doses of ibrutinib on the same day to make up
for a missed dose.
Participant will be given a study drug diary to write down what time they take each dose of
ibrutinib. Participant needs to bring the study drug diary, any leftover study drug, and any
empty study drug containers with them to each visit.
The dose of ibrutinib participant receives 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 participant's first dose of ibrutinib, blood (about 2 tablespoons) will be drawn
for routine tests and to check their kidney and liver function. The blood draws may be
performed at MD Anderson or at a lab closer to participant's home.
If the study doctor thinks it is needed, participant may need to have these blood draws more
often.
Around 1 month after participant's first dose of ibrutinib, they 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anesthetic, and a small amount of bone and bone marrow is withdrawn through a large needle.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 participant's first
dose of ibrutinib:
- Participant will have a physical exam.
- Participant will have computed tomography (CT) scans to check the status of the
disease. If the doctor thinks it is needed, participant will also have a positron
emission tomography (PET) scan.
- Participant will have a bone marrow biopsy/aspirate to check the status of the disease.
Length of Study:
Participant may continue taking the study drug for up to 3 years. Participant will no longer
be able to take the study drug if the disease gets worse, if intolerable side effects occur,
or if they are unable to follow study directions.
Patient's participation on this study will be over after about 3 years.
Follow-Up Visit:
Participant 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.
This is an investigational study. Ibrutinib is FDA-approved and commercially available for
the treatment of 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.
| Name | Type | Description | Interventions |
|---|---|---|---|
| Ibrutinib | Experimental | Ibrutinib started at a daily dose of 560 mg by mouth daily for up to 3 years. | Ibrutinib |
Inclusion Criteria:
1. 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.
2. 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.
3. ANC >/= 1,000, platelets >/= 75,000.
4. AST and/or ALT < 3 times the ULN.
5. Creatinine clearance > 30 ml/min (Cockcroft-Gault formula using ideal body weight).
6. Male or female age >/= 18 years.
7. ECOG performance status </= 2.
8. Willing and able to participate in all required evaluations and procedures in this
study protocol including swallowing capsules without difficulty.
9. Ability to understand the purpose and risks of the study and provide signed and dated
informed consent and authorization to use protected health information.
10. 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.
Exclusion Criteria:
1. 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.
2. Relapsed within three months post transplant.
3. History of other malignancies within the past year except for treated basal cell or
squamous cell skin cancer or in situ cervical cancer.
4. Known CNS lymphoma.
5. 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.
6. Requires treatment with a strong cytochrome P450 (CYP)3A inhibitor (i.e.
Voriconazole, posaconazole, itraconazole, clarithromycin, etc.) or inducer
(carbamazepine, rifampin, phenytoin, etc.).
7. AST and/or ALT >/= 3 times the ULN.
8. 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.
9. Known history of human immunodeficiency virus or active infection with hepatitis C
virus or hepatitis B virus or any uncontrolled active systemic infection.
10. Positive pregnancy test in women of childbearing potential.
11. 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.
12. Concomitant use of warfarin or other Vitamin K antagonists.
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both
Disease-Free Survival Rate
Lymphoma
Blood And Marrow Transplantation
Post Autologous Stem Cell Transplantation
SCT
B-cell lymphoma
Ibrutinib
PCI-32765
Imbruvica
