Acute Lymphoblastic LeukemiaPhase 1/2NCT02404220
Safety and Efficacy of Entospletinib With Vincristine and Dexamethasone in Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)
A Phase 1/2 study testing Entospletinib, Vincristine and Dexamethasone in people with Acute Lymphoblastic Leukemia, run by Gilead Sciences at 13 sites in 3 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Entospletinib, Vincristine and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 13 sitesin 3 countries
- Study dates
- 6 May 2015to 17 Dec 2018
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with ALL in need of treatment
Who cannot join
- Diagnosis of Burkitt's Leukemia, or lymphoid blast crisis of chronic myelogenous leukemia (CML)
- History of myelodysplastic syndrome or solid organ transplantation
- Prior allogeneic bone marrow progenitor cell transplant within 100 days or on active immunosuppression for graft versus host disease (GVHD) treatment or prophylaxis within 28 days prior to enrollment
- Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
United States10 sites
University of Chicago
Chicago, Illinois, 60637
The Ohio State University
Columbus, Ohio, 43210
City of Hope
Duarte, California, 91010
Bon Secour St. Francis Hospital
Greenville, South Carolina, 29601
Hackensack University Medical Center
Hackensack, New Jersey, 07601
UCLA
Los Angeles, California, 90095
Memorial Sloan-Kettering
New York, New York, 10021
UC Irvine Medical Center
Orange, California, 92608
University of California San Diego (UCSD)
San Diego, California, 92093
University of WA
Seattle, Washington, 98109
Germany2 sites
Medizinische Klinik mit Schwerpunkt Hepatologie & Gastroenterology
Berlin, 12200
Medizinische Klinik und Poliklinik I
Würzburg
About this study
Official title: A Phase 1b/2, Open-Label, Dose Escalation and Expansion Study Evaluating the Safety and Efficacy of Entospletinib (GS-9973) With Vincristine and Dexamethasone in Adult Subjects With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)
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.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Entospletinib, Vincristine, Dexamethasone, CNS Prophylaxis
- Keywords
- Syk inhibitor, Blood malignancy, Leukemia
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntospletinibDrug
Also called GS-9973, ENTO
VincristineDrug
Also called VCR
DexamethasoneDrug
Also called DEX
CNS ProphylaxisDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Entospletinib; Drug: Vincristine; Drug: Dexamethasone; Drug: CNS Prophylaxis |
| 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. Receives: Drug: Entospletinib; Drug: Vincristine; Drug: Dexamethasone; Drug: CNS Prophylaxis |
| 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. Receives: Drug: Entospletinib; Drug: Vincristine; Drug: Dexamethasone; Drug: CNS Prophylaxis |
| 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. Receives: Drug: Entospletinib; Drug: Vincristine; Drug: Dexamethasone; Drug: CNS Prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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):
- Grade 4 (or higher) non-hematologic toxicity
- Grade 3 non-hematologic toxicity lasting ≥ 7 days despite optimal supportive care
- Any Grade 3 non-hematologic laboratory value if:
- Medical intervention was required to treat, or
- The abnormality led to hospitalization, or
- The abnormality persisted for > 1 week
- Grade 4 Neutropenia (absolute neutrophil count [ANC] < 500 /μL) persistent for greater than 14 days or associated with febrile neutropenia
- Grade 4 thrombocytopenia (platelets < 25,000/μL) persisting for greater than 14 days (or greater than 25,000 /μL, but requiring prophylactic platelet transfusion to maintain this level)
Measured: ENTO Lead-in and Cycle 1 (Day -7 through Day 28)
Secondary outcomes (4)
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:
- No circulating blasts or extramedullary disease (no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/CNS involvement).
- Trilineage hematopoiesis (TLH) and < 5% blasts in bone marrow aspirate.
- ANC > 1000/μL.
- Platelets > 100,000/μL.
Measured: 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:
- No circulating blasts or extramedullary disease (no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/CNS involvement).
- TLH and < 5% blasts in bone marrow aspirate.
- ANC > 1000/μL.
- Platelets > 100,000/μL.
CRi required all criteria for CR except platelet count and/or ANC:
- Platelets ≤ 100,000/μL and/or ANC is ≤ 1000/μL
Measured: 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:
- No circulating blasts or extramedullary disease (no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/CNS involvement).
- TLH and bone marrow may contain ≥ 5% but less than 25% blast morphology.
- ANC > 1000/μL.
- Platelets > 100,000/μL.
Measured: 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:
- No circulating blasts or extramedullary disease (no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/CNS involvement).
- TLH and < 5% blasts in bone marrow aspirate.
- ANC > 1000/μL.
- Platelets > 100,000/μL.
CRi required all criteria for CR except platelet count and/or ANC:
- Platelets ≤ 100,000/μL and/or ANC is ≤ 1000/μL
PR required all criteria for CR except for bone marrow blasts:
- bone marrow may contain ≥ 5% but less than 25% blast morphology
Measured: End of Induction (Cycle 2, Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study start6 May 2015
- Primary completion16 Nov 2018
- Study completion17 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404220
- Sponsor's protocol ID
- GS-US-339-1560
- Other IDs
- 2015-002768-18, 2015
- Status last verified
- Dec 2019
- First submitted
- 2 Mar 2015
- Last updated
- 2 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2, Open-Label, Dose Escalation and Expansion Study Evaluating the Safety and Efficacy of Entospletinib (GS-9973) With Vincristine and Dexamethasone in Adult Subjects With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)
- ClinicalTrials.gov ID
- NCT02404220
- Acronym / sponsor ID
- GS-US-339-1560
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Syk inhibitor, Blood malignancy, Leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 6 May 2015 (actual)
- Primary completion
- 16 Nov 2018 (actual)
- Study completion
- 17 Dec 2018 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Posted 2 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ENTO 200 mg + VCR 0.5 mg | Experimental | Drug: Entospletinib, Drug: Vincristine, Drug: Dexamethasone, Drug: CNS ProphylaxisMonotherapy 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 | Drug: Entospletinib, Drug: Vincristine, Drug: Dexamethasone, Drug: CNS ProphylaxisMonotherapy 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. |
| ENTO 400 mg + VCR 1.0 mg | Experimental | Drug: Entospletinib, Drug: Vincristine, Drug: Dexamethasone, Drug: CNS ProphylaxisMonotherapy 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 | Drug: Entospletinib, Drug: Vincristine, Drug: Dexamethasone, Drug: CNS ProphylaxisMonotherapy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with ALL in need of treatment
Key exclusion criteria (4 listed)
- Diagnosis of Burkitt's Leukemia, or lymphoid blast crisis of chronic myelogenous leukemia (CML)
- History of myelodysplastic syndrome or solid organ transplantation
- Prior allogeneic bone marrow progenitor cell transplant within 100 days or on active immunosuppression for graft versus host disease (GVHD) treatment or prophylaxis within 28 days prior to enrollment
- Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EntospletinibAlso: GS-9973, ENTO | Drug | ENTO 200 mg + VCR 0.5 mg, ENTO 400 mg + VCR 0.5 mg, ENTO 400 mg + VCR 1.0 mg, ENTO 400 mg + VCR 2.0 mg |
| VincristineAlso: VCR | Drug | ENTO 200 mg + VCR 0.5 mg, ENTO 400 mg + VCR 0.5 mg, ENTO 400 mg + VCR 1.0 mg, ENTO 400 mg + VCR 2.0 mg |
| DexamethasoneAlso: DEX | Drug | ENTO 200 mg + VCR 0.5 mg, ENTO 400 mg + VCR 0.5 mg, ENTO 400 mg + VCR 1.0 mg, ENTO 400 mg + VCR 2.0 mg |
| CNS Prophylaxis | Drug | ENTO 200 mg + VCR 0.5 mg, ENTO 400 mg + VCR 0.5 mg, ENTO 400 mg + VCR 1.0 mg, ENTO 400 mg + VCR 2.0 mg |
Primary outcome
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
Time frame: ENTO Lead-in and Cycle 1 (Day -7 through Day 28)
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): * Grade 4 (or higher) non-hematologic toxicity * Grade 3 non-hematologic toxicity lasting ≥ 7 days despite optimal supportive care * Any Grade 3 non-hematologic laboratory value if: * Medical intervention was required to treat, or * The abnormality led to hospitalization, or * The abnormality persisted for > 1 week * Grade 4 Neutropenia (absolute neutrophil count [ANC] < 500 /μL) persistent for greater than 14 days or associated with febrile neutropenia * Grade 4 thrombocytopenia (platelets < 25,000/μL) persisting for greater than 14 days (or greater than 25,000 /μL, but requiring prophylactic platelet transfusion to maintain this level)
4 secondary outcomes
Percentage of Participants With Complete Remission (CR) at the End of Induction
Time frame: End of Induction (Cycle 2, Day 28)
Percentage of Participants With Overall Remission at the End of Induction
Time frame: End of Induction (Cycle 2, Day 28)
Percentage of Participants With Partial Response (PR) at the End of Induction
Time frame: End of Induction (Cycle 2, Day 28)
Percentage of Participants With Overall Response at the End of Induction
Time frame: End of Induction (Cycle 2, Day 28)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Entospletinib, Vincristine and Dexamethasone in people with Acute Lymphoblastic Leukemia, run by Gilead Sciences at 13 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Germany, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) (time frame: ENTO Lead-in and Cycle 1 (Day -7 through Day 28)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.