Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002768-18 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to evaluate the safety of entospletinib in combination with vincristine (VCR), and dexamethasone (DEX) in adults with previously treated relapsed or refractory B-cell lineage acute lymphoblastic leukemia (ALL).
This is a dose escalation study in which after 2 induction cycles participants may be put on maintenance for up to 36 cycles if they have obtained clinical benefit from the treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENTO 200 mg + VCR 0.5 mg | Experimental | Monotherapy Lead-In (Day -7 to Day -1): Entospletinib (ENTO) 200 mg tablet orally twice daily as a single agent. Induction (two 28-day cycles): ENTO 200 mg twice daily continuously in combination with vincristine (VCR) 0.5 mg intravenously (IV) on Days 1, 8, 15, and 22 of each cycle; dexamethasone (DEX) 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and central nervous system (CNS) prophylaxis per institutional standards on Day 28 of each cycle. Maintenance (up to 36, 28-day cycles): Participants who achieved a complete remission (CR) received stem cell transplant (SCT) (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a partial response [PR]) after induction were offered maintenance therapy with ENTO 200 mg twice daily continuously in combination with VCR 0.5 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle. |
|
| ENTO 400 mg + VCR 0.5 mg | Experimental | Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent. Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 0.5 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle. Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 0.5 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entospletinib | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) | The occurrence of any of the following toxicities during Lead-in/Cycle 1 (Day -7 through Day 28) was considered a DLT if judged by the investigator to be possibly, probably, or definitely related to the administration of any drug in the treatment regimen (ENTO, VCR, DEX, institutional standard CNS prophylaxis):
| ENTO Lead-in and Cycle 1 (Day -7 through Day 28) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Remission (CR) at the End of Induction | Assessment of clinical response was made according to National Comprehensive Cancer Network (NCCN) guidelines on acute lymphoblastic leukemia (ALL) Version 2, 2016. CR required all of the following:
|
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| UCLA |
Not provided
Not provided
Not provided
Not provided
Not provided
42 participants were screened.
Participants were enrolled at study sites in Germany, Canada, and United States. The first participant was screened on 06 May 2015. The last study visit occurred on 17 December 2018.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ENTO 200 mg + VCR 0.5 mg | Monotherapy Lead-In (Day -7 to Day -1): Entospletinib (ENTO) 200 mg tablet orally twice daily as a single agent. Induction (two 28-day cycles): ENTO 200 mg twice daily continuously in combination with vincristine (VCR) 0.5 mg intravenously (IV) on Days 1, 8, 15, and 22 of each cycle; dexamethasone (DEX) 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and central nervous system (CNS) prophylaxis per institutional standards on Day 28 of each cycle. Maintenance (up to 36, 28-day cycles): Participants who achieved a complete remission (CR) received stem cell transplant (SCT) (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a partial response [PR]) after induction were offered maintenance therapy with ENTO 200 mg twice daily continuously in combination with VCR 0.5 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 3, 2018 | Oct 2, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ENTO 400 mg + VCR 1.0 mg | Experimental | Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent. Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 1.0 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle. Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 1.0 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle. |
|
| ENTO 400 mg + VCR 2.0 mg | Experimental | Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent. Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 2.0 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle. Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 2.0 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle. |
|
| Vincristine | Drug |
|
|
| Dexamethasone | Drug |
|
|
| CNS Prophylaxis | Drug |
|
| End of Induction (Cycle 2, Day 28) |
| Percentage of Participants With Overall Remission at the End of Induction | Assessment of clinical response was made according to NCCN guidelines on ALL Version 2, 2016. Overall remission included CR and complete remission with incomplete hematologic recovery (CRi). CR required all of the following:
CRi required all criteria for CR except platelet count and/or ANC:
| End of Induction (Cycle 2, Day 28) |
| Percentage of Participants With Partial Response (PR) at the End of Induction | PR required all of the following:
| End of Induction (Cycle 2, Day 28) |
| Percentage of Participants With Overall Response at the End of Induction | Overall response included CR, CRi, and PR. CR required all of the following:
CRi required all criteria for CR except platelet count and/or ANC:
PR required all criteria for CR except for bone marrow blasts:
| End of Induction (Cycle 2, Day 28) |
| Los Angeles |
| California |
| 90095 |
| United States |
| UC Irvine Medical Center | Orange | California | 92608 | United States |
| University of California San Diego (UCSD) | San Diego | California | 92093 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Memorial Sloan-Kettering | New York | New York | 10021 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Bon Secour St. Francis Hospital | Greenville | South Carolina | 29601 | United States |
| University of WA | Seattle | Washington | 98109 | United States |
| Princess Margaret | Toronto | Ontario | Canada |
| Medizinische Klinik mit Schwerpunkt Hepatologie & Gastroenterology | Berlin | 12200 | Germany |
| Medizinische Klinik und Poliklinik I | Würzburg | Germany |
| FG001 | ENTO 400 mg + VCR 0.5 mg | Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent. Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 0.5 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle. Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 0.5 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle. |
| FG002 | ENTO 400 mg + VCR 1.0 mg | Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent. Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 1.0 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle. Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 1.0 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle. |
| FG003 | ENTO 400 mg + VCR 2.0 mg | Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent. Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 2.0 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle. Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 2.0 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All Enrolled Analysis Set included all participants who received a study identification number in the study after screening.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ENTO 200 mg + VCR 0.5 mg | Monotherapy Lead-In (Day -7 to Day -1): ENTO 200 mg tablet orally twice daily as a single agent. Induction (two 28-day cycles): ENTO 200 mg twice daily continuously in combination with VCR 0.5 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle. Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 200 mg twice daily continuously in combination with VCR 0.5 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle. |
| BG001 | ENTO 400 mg + VCR 0.5 mg | Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent. Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 0.5 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle. Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 0.5 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle. |
| BG002 | ENTO 400 mg + VCR 1.0 mg | Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent. Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 1.0 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle. Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 1.0 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle. |
| BG003 | ENTO 400 mg + VCR 2.0 mg | Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent. Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 2.0 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle. Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 2.0 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Participants in Full Analysis Set (all participants who received at least 1 dose of study treatment) were analyzed. | Mean | Standard Deviation | years |
| |||||||||
| Sex: Female, Male | Participants in Full Analysis Set were analyzed. | Count of Participants | Participants | No |
| |||||||||
| Race/Ethnicity, Customized | Participants in Full Analysis Set were analyzed. | Count of Participants | Participants | No |
| |||||||||
| Race/Ethnicity, Customized | Participants in Full Analysis Set were analyzed. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) | The occurrence of any of the following toxicities during Lead-in/Cycle 1 (Day -7 through Day 28) was considered a DLT if judged by the investigator to be possibly, probably, or definitely related to the administration of any drug in the treatment regimen (ENTO, VCR, DEX, institutional standard CNS prophylaxis):
| DLT Analysis Set included all participant in the Safety Analysis Set (all participants who received at least 1 dose of study treatment) who met at least one of the following criteria: received at least 21 days of ENTO, > 50% of planned total dose of VCR and DEX, or experienced a DLT during the DLT assessment window. | Posted | Number | percentage of participants | ENTO Lead-in and Cycle 1 (Day -7 through Day 28) |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Remission (CR) at the End of Induction | Assessment of clinical response was made according to National Comprehensive Cancer Network (NCCN) guidelines on acute lymphoblastic leukemia (ALL) Version 2, 2016. CR required all of the following:
| The Full Analysis Set included all participants who received at least 1 dose of study treatment. | Posted | Number | percentage of participants | End of Induction (Cycle 2, Day 28) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Overall Remission at the End of Induction | Assessment of clinical response was made according to NCCN guidelines on ALL Version 2, 2016. Overall remission included CR and complete remission with incomplete hematologic recovery (CRi). CR required all of the following:
CRi required all criteria for CR except platelet count and/or ANC:
| Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | End of Induction (Cycle 2, Day 28) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Partial Response (PR) at the End of Induction | PR required all of the following:
| Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | End of Induction (Cycle 2, Day 28) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Overall Response at the End of Induction | Overall response included CR, CRi, and PR. CR required all of the following:
CRi required all criteria for CR except platelet count and/or ANC:
PR required all criteria for CR except for bone marrow blasts:
| Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | End of Induction (Cycle 2, Day 28) |
|
Adverse Events: First dose date up to maximum 18 months; All-Cause Mortality: First dose date up to maximum 3.5 years
The Safety Analysis Set included all participants who received at least 1 dose of study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ENTO 200 mg + VCR 0.5 mg | Monotherapy Lead-In (Day -7 to Day -1): ENTO 200 mg tablet orally twice daily as a single agent. Induction (two 28-day cycles): ENTO 200 mg twice daily continuously in combination with VCR 0.5 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle. Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 200 mg twice daily continuously in combination with VCR 0.5 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle. | 5 | 5 | 5 | 5 | 5 | 5 |
| EG001 | ENTO 400 mg + VCR 0.5 mg | Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent. Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 0.5 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle. Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 0.5 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle. | 5 | 6 | 4 | 6 | 5 | 6 |
| EG002 | ENTO 400 mg + VCR 1.0 mg | Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent. Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 1.0 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle. Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 1.0 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle. | 5 | 7 | 5 | 7 | 6 | 7 |
| EG003 | ENTO 400 mg + VCR 2.0 mg | Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent. Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 2.0 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle. Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 2.0 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle. | 9 | 10 | 6 | 10 | 7 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Fungaemia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Sinusitis fungal | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haemolysis | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cushingoid | Endocrine disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Eye haemorrhage | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oral disorder | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Catheter site erythema | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Catheter site haemorrhage | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Crepitations | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Puncture site pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Sinusitis fungal | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood immunoglobulin G decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Escherichia test positive | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Staphylococcus test positive | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Carotid arteriosclerosis | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Device malfunction | Product Issues | MedDRA 20.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Fear | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dysfunctional uterine bleeding | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
Due to the low response rate observed with ENTO + VCR + DEX in adults with relapsed or refractory B-ALL, the sponsor decided not to proceed with Phase 2 (dose-expansion) and the cohort was subsequently closed with no participant enrolled.
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 5 | Apr 13, 2018 | Oct 2, 2019 | Prot_001.pdf |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000589391 | 6-(1H-indazol-6-yl)-N-(4-morpholinophenyl)imidazo(1,2-a)pyrazin-8-amine |
| D014750 | Vincristine |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
|
|
|
|
|
| United States |
|
|
| Germany |
|
|
| OG003 | ENTO 400 mg + VCR 2.0 mg | Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent. Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 2.0 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle. Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 2.0 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle. |
| ENTO 400 mg + VCR 0.5 mg |
Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent. Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 0.5 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle. Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 0.5 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle. |
| OG002 | ENTO 400 mg + VCR 1.0 mg | Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent. Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 1.0 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle. Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 1.0 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle. |
| OG003 | ENTO 400 mg + VCR 2.0 mg | Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent. Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 2.0 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle. Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 2.0 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle. |
|
|
| OG001 | ENTO 400 mg + VCR 0.5 mg | Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent. Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 0.5 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle. Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 0.5 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle. |
| OG002 | ENTO 400 mg + VCR 1.0 mg | Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent. Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 1.0 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle. Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 1.0 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle. |
| OG003 | ENTO 400 mg + VCR 2.0 mg | Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent. Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 2.0 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle. Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 2.0 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle. |
|
|
| OG002 | ENTO 400 mg + VCR 1.0 mg | Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent. Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 1.0 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle. Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 1.0 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle. |
| OG003 | ENTO 400 mg + VCR 2.0 mg | Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent. Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 2.0 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle. Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 2.0 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle. |
|
|
| OG001 | ENTO 400 mg + VCR 0.5 mg | Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent. Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 0.5 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle. Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 0.5 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle. |
| OG002 | ENTO 400 mg + VCR 1.0 mg | Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent. Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 1.0 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle. Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 1.0 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle. |
| OG003 | ENTO 400 mg + VCR 2.0 mg | Monotherapy Lead-In (Day -7 to Day -1): ENTO 400 mg tablet orally twice daily as a single agent. Induction (two 28-day cycles): ENTO 400 mg twice daily continuously in combination with VCR 2.0 mg IV on Days 1, 8, 15, and 22 of each cycle; DEX 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and CNS prophylaxis per institutional standards on Day 28 of each cycle. Maintenance (up to 36, 28-day cycles): Participants who achieved a CR received SCT (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a PR) after induction were offered maintenance therapy with ENTO 400 mg twice daily continuously in combination with VCR 2.0 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle. |
|
|