Efficacy and Safety of Idelalisib in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia
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| ClinicalTrials.gov Identifier: NCT01659021 |
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Recruitment Status :
Terminated
First Posted : August 7, 2012
Results First Posted : March 31, 2017
Last Update Posted : August 14, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Lymphocytic Leukemia | Drug: Idelalisib Drug: Ofatumumab | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 261 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia |
| Actual Study Start Date : | December 4, 2012 |
| Actual Primary Completion Date : | August 15, 2018 |
| Actual Study Completion Date : | August 15, 2018 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Idelalisib+ofatumumab
Randomized Initial Therapy (24 weeks): Idelalisib + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses) Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation. Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone. |
Drug: Idelalisib
150 mg tablets administered orally twice daily
Other Names:
Drug: Ofatumumab Administered intravenously
Other Name: Arzerra® |
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Active Comparator: Ofatumumab
Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses) Continuing Therapy/Observation: Observation until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation. Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone. |
Drug: Ofatumumab
Administered intravenously
Other Name: Arzerra® |
- Progression-Free Survival [ Time Frame: Randomization to End of Study (up to 60 months) ]Progression-free survival (PFS) was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or ≥ 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL. PFS was analyzed using Kaplan-Meier (KM) estimates.
- Overall Response Rate [ Time Frame: Randomization to End of Study (up to 60 months) ]
Overall response rate was defined as the percentage of participants who achieved a best overall response of complete response or partial response.
- Complete response was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy.
- Partial response was defined as >1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus ≥ 1 of the following: ≥ 1500/μL absolute neutrophil count, > 100000/μL platelets, > 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors. Overall response rate was analyzed using KM estimates.
- Lymph Node Response Rate [ Time Frame: Randomization to End of Study (up to 60 months) ]Lymph node response rate was defined as the proportion of participants who achieved a ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lymph nodes.
- Overall Survival [ Time Frame: Randomization to Last Long-Term Follow-Up Visit (up to maximum of 5 years) ]Overall survival was defined as the interval from randomization to death from any cause. Overall survival was analyzed using KM estimates.
- Progression-Free Survival in Subgroup of Participants With Chromosome 17p Deletion and/or TP53 Mutation [ Time Frame: Randomization to End of Study (up to 60 months) ]Progression-free survival in subgroup of participants with chromosome 17p deletion and/or TP53 mutation was analyzed using KM estimates.
- Complete Response Rate [ Time Frame: Randomization to End of Study (up to 60 months) ]Complete response rate was defined as the percentage of participants who achieve a complete response and maintain their response for at least 8 weeks (with a 1-week window).
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Adults with previously treated recurrent CLL who have measurable lymphadenopathy
- Require therapy for CLL
- Have experienced CLL progression < 24 months since the completion of the last prior therapy
- Have disease that is not refractory to ofatumumab
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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): NCT01659021
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| Study Director: | Gilead Study Director | Gilead Sciences |
Documents provided by Gilead Sciences:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01659021 |
| Other Study ID Numbers: |
GS-US-312-0119 2012-001236-65 ( EudraCT Number ) |
| First Posted: | August 7, 2012 Key Record Dates |
| Results First Posted: | March 31, 2017 |
| Last Update Posted: | August 14, 2019 |
| Last Verified: | August 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
| Time Frame: | 18 months after study completion |
| Access Criteria: | A secured external environment with username, password, and RSA code. |
| URL: | http://www.gilead.com/research/disclosure-and-transparency |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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CLL Chronic Lymphocytic Leukemia GS-1101 CAL-101 Ofatumumab |
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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 Ofatumumab Idelalisib Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |