Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Study Overview
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Brief Summary
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An Open-label Extension Study in Patients 65 Years or Older with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib versus Chlorambucil)

Official Title
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An Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib Versus Chlorambucil)

Conditions
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Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Intervention / Treatment
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* Drug: Post-Chlorambucil Therapy Follow-up
* Drug: Ibrutinib
* Drug: Second-line Ibrutinib
* Drug: Alternative Anticancer Treatment
* Drug: Alternative Anti-cancer Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Randomized in the parent study, PCYC-1115-CA Informed consent for Study PCYC-1116-CA IRC-confirmed PD in the parent study PCYC-1115-CA or closure of the parent study Exclusion Criteria: Disease progression involving the central nervous system (CNS) or transformation to another histology Intervening chemotherapy, immunotherapy, or investigational agent specifically to treat CLL if administered before date of IRC confirmed progressive disease In the 4 weeks before dosing: radiation therapy, major surgery, or receipt of an investigational drug Requirement for treatment with a strong CYP3A inhibitor Uncontrolled systemic infection or requirement for IV antibiotics Noncompliance on the parent study(PCYC-1115-CA)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm A Post-Chlorambucil Therapy Followup<br>Patients randomized to Chlorambucil in the parent study(PCYC-1115-CA) who have not progressed at the time of parent study closure will be transferred to this Arm. Follow-up will continue until PD, unacceptable toxicity, or other reason for treatment discontinuation. | Drug: Post-Chlorambucil Therapy Follow-up<br>* Patients remain in this Arm for continued follow-up until PD, unacceptable toxicity, or other reason for treatment discontinuation. All patients in this Arm have completed Chlorambucil therapy. Patients who have progression will exit the study.<br>Drug: Alternative Anticancer Treatment<br>* Specific therapy and treatment regimen are at the Investigator's discretion.<br>|
| Experimental: Arm B Ibrutinib<br>Patients randomized to Ibrutinib in the parent study (PCYC-1115-CA) who have not experienced PD at the time of parent study closure will be transferred to this Arm to continue on Ibrutinib treatment. Treatment will continue until PD, unacceptable toxicity, or other reasons for treatment discontinuation. | Drug: Ibrutinib<br>* Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily.<br>* Other names: PCI-32765;Drug: Alternative Anticancer Treatment<br>* Specific therapy and treatment regimen are at the Investigator's discretion.<br>|
| Experimental: Arm C Second-line Ibrutinib<br>Patients who received Chlorambucil in the parent study (PCYC-1115-CA) and experienced PD are transferred to this Arm for Ibrutinib treatment. Treatment will continue until PD, unacceptable toxicity, or other reasons for treatment discontinuation. | Drug: Second-line Ibrutinib<br>* Patients in this arm who were previously eligible to receive Second-line Ibrutinib will exit the study with option to roll-over to another long-term Ibrutinib study, if eligible.<br>* Other names: PCI-32765;Drug: Alternative Anticancer Treatment<br>* Specific therapy and treatment regimen are at the Investigator's discretion.<br>|
| Other: Arm D Alternative Anticancer Therapy<br>At the Investigator's discretion, alternative anticancer treatment is a therapeutic option for patients who experienced PD during Ibrutinib treatment or during or after Chlorambucil treatment. This Arm can also be considered if drug is discontinued for other reasons (e.g., intolerability or adverse event [AE]) or prior to experiencing PD). | Drug: Alternative Anti-cancer Treatment<br>* Specific therapy and treatment regimen are at the Investigator's discretion. Patients originally randomized to Chlorambucil will exit the study. Patients originally randomized to Ibrutinib will continue on study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) | To monitor progression-free survival (PFS) | 10 years | 
| Safety as measured by all AEs and SAEs for patients randomized to Arm B (Ibrutinib) in Study PCYC-1115-CA | To continue treatment and safety assessment of patients randomized to Arm B (Ibrutinib) in Study PCYC-1115-CA (the parent study) who have not progressed at the time of parent study closure | 10 years | 
| Long-term follow-up and Second-line therapy monitoring | To follow patients for long-term outcome | 10 years | 
| Efficacy evaluation of subsequent therapy | To capture overall response rate (ORR), duration of response (DOR), PFS, and overall survival (OS) to subsequent therapy, and time to next therapy, in patients progressing in the parent study | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CLL, SLL