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

NCT02272686 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: 2014-0096NCI-2015-00843
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma

Keywords

Lymphoma; Blood And Marrow Transplantation; Post Autologous Stem Cell Transplantation; SCT; B-cell lymphoma; Ibrutinib; PCI-32765; Imbruvica

Outcome Measures

Primary Outcomes (1)

• Disease Free Survival (DFS)

  Participants will be assessed for disease status and survival.

  Two years

Secondary Outcomes (1)

• Overall Survival (OS)

  Three Years

Study Arms (1)

Ibrutinib

EXPERIMENTAL

Ibrutinib started at a daily dose of 560 mg by mouth daily for up to 3 years.

Drug: Ibrutinib

Interventions

Ibrutinib DRUG

560 mg by mouth daily.

Also known as: PCI-32765, Imbruvica

Ibrutinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.).
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Pharmacyclics LLC.: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lymphoma; Lymphoma, B-Cell

Interventions

ibrutinib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Results Point of Contact

• Title: Issa F. Khouri, MD, Professor, Stem Cell Transplantation
• Organization: UT MD Anderson Cancer Center

ikhouri@mdanderson.org

713-745-0049

Study Officials

• Issa F. Khouri, MD, BS

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: October 23, 2014
• Study Start: June 3, 2016
• Primary Completion: December 22, 2017
• Study Completion: December 22, 2017
• Last Updated: December 5, 2018
• Results First Posted: December 5, 2018

Record last verified: 2018-11

Locations

US (1)