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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

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.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: Ibrutinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Targeting Bruton's Tyrosine Kinase (BTK) With Ibrutinib After Autologous Stem Cell Transplantation in "Double-Hit" B-Cell Lymphoma
Actual Study Start Date : June 3, 2016
Actual Primary Completion Date : December 22, 2017
Actual Study Completion Date : December 22, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Ibrutinib

Arm Intervention/treatment
Experimental: Ibrutinib
Ibrutinib started at a daily dose of 560 mg by mouth daily for up to 3 years.
Drug: Ibrutinib
560 mg by mouth daily.
Other Names:
  • PCI-32765
  • Imbruvica

Primary Outcome Measures :
  1. Disease Free Survival (DFS) [ Time Frame: Two years ]
    Participants will be assessed for disease status and survival.

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Three Years ]
    Participants will be assessed at 3 year time point for survival.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02272686

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Pharmacyclics LLC.
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Principal Investigator: Issa F. Khouri, MD, BS M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT02272686    
Other Study ID Numbers: 2014-0096
NCI-2015-00843 ( Registry Identifier: NCI CTRP )
First Posted: October 23, 2014    Key Record Dates
Results First Posted: December 5, 2018
Last Update Posted: December 5, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Blood And Marrow Transplantation
Post Autologous Stem Cell Transplantation
B-cell lymphoma
Additional relevant MeSH terms:
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Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin