Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic 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. |
ClinicalTrials.gov Identifier: NCT01724346 |
Recruitment Status :
Active, not recruiting
First Posted : November 9, 2012
Last Update Posted : August 9, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma | Drug: Post-Chlorambucil Therapy Follow-up Drug: Ibrutinib Drug: Second-line Ibrutinib Drug: Alternative Anticancer Treatment Drug: Alternative Anti-cancer Treatment | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 232 participants |
Allocation: | Non-Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Masking Description: | Open label study |
Primary Purpose: | Treatment |
Official Title: | 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) |
Actual Study Start Date : | August 28, 2012 |
Estimated Primary Completion Date : | April 3, 2023 |
Estimated Study Completion Date : | April 3, 2023 |

Arm | Intervention/treatment |
---|---|
Arm A Post-Chlorambucil Therapy Followup
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
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. Drug: Alternative Anticancer Treatment Specific therapy and treatment regimen are at the Investigator's discretion. |
Experimental: Arm B Ibrutinib
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
Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily.
Other Name: PCI-32765 Drug: Alternative Anticancer Treatment Specific therapy and treatment regimen are at the Investigator's discretion. |
Experimental: Arm C Second-line Ibrutinib
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
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.
Other Name: PCI-32765 Drug: Alternative Anticancer Treatment Specific therapy and treatment regimen are at the Investigator's discretion. |
Arm D Alternative Anticancer Therapy
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
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. |
- Progression-free Survival (PFS) [ Time Frame: 10 years ]To monitor progression-free survival (PFS)
- Safety as measured by all AEs and SAEs for patients randomized to Arm B (Ibrutinib) in Study PCYC-1115-CA [ Time Frame: 10 years ]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
- Long-term follow-up and Second-line therapy monitoring [ Time Frame: 10 years ]To follow patients for long-term outcome
- Efficacy evaluation of subsequent therapy [ Time Frame: 10 years ]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

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.
Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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 ClinicalTrials.gov identifier (NCT number): NCT01724346

Study Director: | Jim Dean, MD, PhD | Pharmacyclics LLC. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pharmacyclics LLC. |
ClinicalTrials.gov Identifier: | NCT01724346 |
Other Study ID Numbers: |
PCYC-1116-CA 2012-003968-44 ( EudraCT Number ) |
First Posted: | November 9, 2012 Key Record Dates |
Last Update Posted: | August 9, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | We share this information with FDA and other authorities for the purposes of analyzing the study but not with other researchers |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
CLL, SLL |
Lymphoma Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Chlorambucil Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |