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Ibrutinib Post Stem Cell Transplantation (SCT) in Double-Hit B-Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02272686
Recruitment Status : Terminated (Slow Accrual)
First Posted : October 23, 2014
Results First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Pharmacyclics LLC.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE October 21, 2014
First Posted Date  ICMJE October 23, 2014
Results First Submitted Date  ICMJE October 2, 2018
Results First Posted Date  ICMJE December 5, 2018
Last Update Posted Date December 5, 2018
Actual Study Start Date  ICMJE June 3, 2016
Actual Primary Completion Date December 22, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2018)
Disease Free Survival (DFS) [ Time Frame: Two years ]
Participants will be assessed for disease status and survival.
Original Primary Outcome Measures  ICMJE
 (submitted: October 21, 2014)
Disease-Free Survival Rate [ Time Frame: 2 years ]
Primary endpoint estimated using a 95% confidence interval, and drop-outs counted as non-responders.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2018)
Overall Survival (OS) [ Time Frame: Three Years ]
Participants will be assessed at 3 year time point for survival.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Ibrutinib Post Stem Cell Transplantation (SCT) in Double-Hit B-Cell Lymphoma
Official Title  ICMJE Targeting Bruton's Tyrosine Kinase (BTK) With Ibrutinib After Autologous Stem Cell Transplantation in "Double-Hit" B-Cell Lymphoma
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma
Intervention  ICMJE Drug: Ibrutinib
560 mg by mouth daily.
Other Names:
  • PCI-32765
  • Imbruvica
Study Arms  ICMJE Experimental: Ibrutinib
Ibrutinib started at a daily dose of 560 mg by mouth daily for up to 3 years.
Intervention: Drug: Ibrutinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 22, 2017)
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2014)
Actual Study Completion Date  ICMJE December 22, 2017
Actual Primary Completion Date December 22, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02272686
Other Study ID Numbers  ICMJE 2014-0096
NCI-2015-00843 ( Registry Identifier: NCI CTRP )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE Pharmacyclics LLC.
Investigators  ICMJE
Principal Investigator: Issa F. Khouri, MD, BS M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP