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

• Status: Terminated
• Trial end date: 2017-12-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Pharmacyclics LLC.

Criteria

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

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.