LeukemiaPhase 1/2NCT02096042
Phase I/II - Brentuximab/5-Azacytidine in Acute Myeloid Leukemia (AML)
A Phase 1/2 study testing Brentuximab Vedotin and 5-Azacytidine in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This clinical research study is made up of 3 phases: a Pilot Phase, Phase 1, and Phase 2. The goal of the Pilot Phase is to learn how safe it is to give the study drug brentuximab vedotin to patients with AML. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- Brentuximab Vedotin and 5-Azacytidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Aug 2016
- 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
- Histologically or cytologically confirmed AML, other than acute promyelocytic leukemia, as defined by the 2008 World Health Organization (WHO) criteria that is relapsed or refractory to standard chemotherapy. Note: Newly-diagnosed AML patients who are 60 years or older and are not candidates for or have refused standard chemotherapy are also eligible for this trial.
- AML blasts must express CD30 (>/=10% expression as assessed by flow-cytometry or 2+ expression by immunohistochemistry) (whenever possible CD30 expression will be assessed by both methods)
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of </=3
- The following baseline laboratory data: Serum bilirubin </=1.5 x upper limit of normal (ULN) or </= 3 x ULN for patients with Gilbert's disease; Serum creatinine </=1.5 x ULN AND creatinine clearance >30 ml/min; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) </=3 x ULN
- Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotrophin (beta-hCG) pregnancy test result within 14 days prior to the first dose of brentuximab vedotin and must agree to use an effective contraception method during the study and for 30 days following the last dose of study drug. Females of non- childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
- Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug
- Patients or their legally authorized representative must provide written informed consent.
Who cannot join
- History of another primary invasive malignancy that has not been definitively treated or in remission for at least 2 years. Patients with non-melanoma skin cancers or with carcinomas in situ are eligible regardless of the time from diagnosis (including concomitant diagnoses).
- Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association Class III-IV within 6 months prior to their first dose of brentuximab vedotin
- Evidence of active cerebral/meningeal disease. Patients may have history of central nervous system (CNS) leukemic involvement if definitively treated with prior therapy and no evidence of active disease at the time of registration.
- Previous treatment with any anti-CD30 directed therapy
- Patients with previous allogeneic stem cell transplant (SCT) if they meet either of the following criteria: <100 days from allogeneic SCT, Acute or chronic graft-versus-host disease (GvHD), or Receiving immunosuppressive therapy as treatment for or prophylaxis against GvHD within the last 7 days
- Patients with uncontrolled active infections (viral, bacterial, and fungal) are not eligible.
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- Known to be positive for hepatitis B by surface antigen expression
- Known to have active hepatitis C infection (positive by polymerase chain reaction or on antiviral therapy for hepatitis C within the last 6 months)
- Preexisting grade >/=2 peripheral neuropathy
- Patients with uncontrolled diabetes mellitus
- Current therapy with other systemic anti-neoplastic or anti-neoplastic investigational agents.
- Chemotherapy (except hydroxyurea or emergent use of single-agent cytarabine for cytoreduction), radiotherapy, biologics, and/or other treatment with immunotherapy that is not completed 2 weeks prior to first dose of study drug, unless progressive disease is documented. NOTE: Hydroxyurea will be allowed during the first cycle of treatment
- Females who are pregnant or lactating
- Known hypersensitivity to any excipient contained in the drug formulation of brentuximab vedotin
- History of progressive multifocal leukoencephalopathy (PML)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase I/II Study of Weekly Schedule Of Brentuximab Vedotin Alone and In Combination With 5-Azacytidine In Cluster of Differentiation Antigen (CD30)-Positive Relapsed/Refractory Acute Myeloid Leukemia
This clinical research study is made up of 3 phases: a Pilot Phase, Phase 1, and Phase 2.
The goal of the Pilot Phase is to learn how safe it is to give the study drug brentuximab vedotin to patients with AML. The goal of Phase 1 is to learn more about the safety of the combination of brentuximab vedotin with azacytidine. The goal of Phase 2 is to learn if the combination of brentuximab vedotin and azacytidine can help to control AML.
Read the detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 3 groups of 3-6 participants will be enrolled in the Pilot Phase, up to 3 groups of 3-6 participants will be enrolled in Phase I of the study, and up to 25 participants will be enrolled in Phase II.
If you are enrolled in the Pilot Phase, the dose of brentuximab vedotin you receive will depend on when you joined this study. The first group of participants will receive the highest dose level of brentuximab vedotin. If intolerable side effects are seen, up to 2 more groups will be enrolled and will receive a lower dose of brentuximab vedotin than the group before it. If intolerable side effects are not seen, the next phase of the study will begin.
If you are enrolled in Phase I, the dose of brentuximab vedotin you receive will depend on when you joined this study. The first group of participants will receive a lower dose level of brentuximab vedotin than the highest one that was tolerated in the Pilot Phase, and will also receive azacitidine. If intolerable side effects are seen, up to 2 more groups will be enrolled and will receive a lower dose of brentuximab vedotin than the group before it. If intolerable side effects are not seen, the next phase of the study will begin.
If you are enrolled in Phase 2, you will receive brentuximab vedotin at the highest dose that was tolerated in Phase 1.
All participants in Phases 1 and 2 will receive the same dose level of azacytidine.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive brentuximab vedotin by vein over 30 minutes on Days 1, 8, and 15 of each 28-day study cycle. If the disease appears to get better, or after cycle 4, the dose and schedule of brentuximab vedotin may be changed to monthly rather than weekly doses.
If you are in Phase 1 or Phase 2, you will also receive azacytidine by vein or as an injection under the skin on Days 1-7 of each cycle.
You may be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.
Study Visits:
On Day 1 of each cycle:
- You will have a physical exam.
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
- You will have an EKG.
- Every 3 Cycles (Cycles 3, 6, 9, and so on), if you can become pregnant, blood (about 1 teaspoon) or urine will be collected for a pregnancy test.
On Days 8 and 22 of Cycle 1, blood (about 2-3 tablespoons) will be drawn for routine tests.
On Day 15 of Cycle 1:
- You will have a physical exam.
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
On Day 28 of Cycle 1, then Day 1 of every 2 cycles after that (Cycles 3, 5, 7, and so on), you will have a bone marrow biopsy and/or aspirate to check the status of the disease. After any point that the disease appears to get better, this will be done every 3-4 cycles, or whenever your doctor thinks it is needed.
Length of Treatment:
You may receive the study drug for up to 12 cycles. You will no longer be able to receive the study drug(s) if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over after the end-of-study visit.
End-of-Study Visit:
About 28 days after your last dose of study drug, you will have an end-of-study visit:
- You will have a physical exam.
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
- You will have an EKG to check your heart function.
- You may have a bone marrow biopsy and/or aspirate to check the status of the disease.
- If you can become pregnant, blood (about 1 teaspoon) or urine will be collected for a pregnancy test.
If the End-of-Study Visit occurs within 21 days of your last dose, you will be called by a member of the study team about 30-37 days after your last dose of study drug. You will be asked how you are feeling and about any side effects you may be having. This call will last about 5 minutes.
This is an investigational study. Brentuximab vedotin is FDA approved and commercially available for the treatment of certain types of lymphoma after previous treatments have failed. Its use in combination with azacitidine is investigational. Azacytidine is FDA approved and commercially available for the treatment of myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML).
The study doctor can explain how the study drug(s) are designed to work.
Up to 61 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Leukemia
- Being tested
- Brentuximab Vedotin, 5-Azacytidine
- Keywords
- Leukemia, Acute Myeloid Leukemia, AML, CD30-Positive, Relapsed, Refractory, Brentuximab Vedotin, SGN-35, Adcetris, 5-Azacytidine, Azacytidine, Azacitidine, 5-aza, Vidaza, 5-AZC, AZA-CR, Ladakamycin, NSC-102816
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brentuximab VedotinDrug
Also called SGN-35, Adcetris
Pilot Phase: Starting dose of Brentuximab Vedotin 1.2 mg/kg intravenous (IV) infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle.
Phase I Dose-Escalation Phase: Starting dose of Brentuximab Vedotin 1.0 mg/kg IV (starting dose level 1), or one-dose level lower than the established MTD if the pilot portion of the study establishes a lower MTD, infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle.
Phase II Dose-Expansion Phase: Patients receive Brentuximab Vedotin at MTD from dose-escalation phase by vein on Days 1, 8, and 15 of each 28-day cycle.
5-AzacytidineDrug
Also called Azacytidine, Azacitidine, 5-aza, Vidaza
Phase I Dose-Escalation Phase and Phase II Dose-Expansion Phase: 5-Azacytidine at 75 mg/m2/day by vein or subcutaneously on days 1-7 every 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Brentuximab Vedotin | Experimental | Pilot Phase: Starting dose of Brentuximab Vedotin 1.2 mg/kg intravenous (IV) infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle (+/- 3 days). Receives: Drug: Brentuximab Vedotin |
| Brentuximab Vedotin + 5-Azacytidine | Experimental | Phase I Dose-Escalation Phase: Starting dose of Brentuximab Vedotin 1.0 mg/kg IV (starting dose level 1), or one-dose level lower than the established MTD if the pilot portion of the study establishes a lower MTD, infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle. All patients receive 5-azacytidine at 75 mg/m2/day by vein or subcutaneously on days 1-7 every 28 days.
Phase II Dose-Expansion Phase: Patients receive Brentuximab Vedotin at MTD from dose-escalation phase by vein on Days 1, 8, and 15 of each 28-day cycle. Patients receive 5-Azacytidine at 75 mg/m2/day by vein or subcutaneously on days 1-7 every 28 days. Patients can receive up to a total of 12 cycles of treatment (weekly + monthly combined). Receives: Drug: Brentuximab Vedotin; Drug: 5-Azacytidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Brentuximab Vedotin in Combination With 5-Azacytidine
MTD defined as maximum dose at which <33% of patients experience a dose-limiting toxicity (DLT) during cycle 1.
Measured: After 1, 28 day cycle
Overall Response Rate
Response defined as number of participants with complete response (CR), CR with incomplete platelet recovery (CRp), CR with insufficient hematological recovery (CRi) or partial remission (PR).
Measured: Response assessed after four 28-day cycles, up to 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2016
- Study completionAug 2016
Why it stopped: Slow accrual.
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 LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Seagen Inc.
- Responsible party
- Sponsor
- Investigators
- Nitin Jain, MBBS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096042
- Sponsor's protocol ID
- 2013-0706
- Other IDs
- NCI-2014-01114
- Status last verified
- Oct 2023
- First submitted
- 20 Mar 2014
- Last updated
- 10 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Weekly Schedule Of Brentuximab Vedotin Alone and In Combination With 5-Azacytidine In Cluster of Differentiation Antigen (CD30)-Positive Relapsed/Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT02096042
- Acronym / sponsor ID
- 2013-0706
- Conditions
- Leukemia
- Keywords
- Leukemia, Acute Myeloid Leukemia, AML, CD30-Positive, Relapsed, Refractory, Brentuximab Vedotin, SGN-35
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Seagen Inc.
- Study start
- Apr 2014 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Posted 5 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical research study is made up of 3 phases: a Pilot Phase, Phase 1, and Phase 2.
The goal of the Pilot Phase is to learn how safe it is to give the study drug brentuximab vedotin to patients with AML. The goal of Phase 1 is to learn more about the safety of the combination of brentuximab vedotin with azacytidine. The goal of Phase 2 is to learn if the combination of brentuximab vedotin and azacytidine can help to control AML.
Detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 3 groups of 3-6 participants will be enrolled in the Pilot Phase, up to 3 groups of 3-6 participants will be enrolled in Phase I of the study, and up to 25 participants will be enrolled in Phase II.
If you are enrolled in the Pilot Phase, the dose of brentuximab vedotin you receive will depend on when you joined this study. The first group of participants will receive the highest dose level of brentuximab vedotin. If intolerable side effects are seen, up to 2 more groups will be enrolled and will receive a lower dose of brentuximab vedotin than the group before it. If intolerable side effects are not seen, the next phase of the study will begin.
If you are enrolled in Phase I, the dose of brentuximab vedotin you receive will depend on when you joined this study. The first group of participants will receive a lower dose level of brentuximab vedotin than the highest one that was tolerated in the Pilot Phase, and will also receive azacitidine. If intolerable side effects are seen, up to 2 more groups will be enrolled and will receive a lower dose of brentuximab vedotin than the group before it. If intolerable side effects are not seen, the next phase of the study will begin.
If you are enrolled in Phase 2, you will receive brentuximab vedotin at the highest dose that was tolerated in Phase 1.
All participants in Phases 1 and 2 will receive the same dose level of azacytidine.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive brentuximab vedotin by vein over 30 minutes on Days 1, 8, and 15 of each 28-day study cycle. If the disease appears to get better, or after cycle 4, the dose and schedule of brentuximab vedotin may be changed to monthly rather than weekly doses.
If you are in Phase 1 or Phase 2, you will also receive azacytidine by vein or as an injection under the skin on Days 1-7 of each cycle.
You may be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.
Study Visits:
On Day 1 of each cycle:
- You will have a physical exam.
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
- You will have an EKG.
- Every 3 Cycles (Cycles 3, 6, 9, and so on), if you can become pregnant, blood (about 1 teaspoon) or urine will be collected for a pregnancy test.
On Days 8 and 22 of Cycle 1, blood (about 2-3 tablespoons) will be drawn for routine tests.
On Day 15 of Cycle 1:
- You will have a physical exam.
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
On Day 28 of Cycle 1, then Day 1 of every 2 cycles after that (Cycles 3, 5, 7, and so on), you will have a bone marrow biopsy and/or aspirate to check the status of the disease. After any point that the disease appears to get better, this will be done every 3-4 cycles, or whenever your doctor thinks it is needed.
Length of Treatment:
You may receive the study drug for up to 12 cycles. You will no longer be able to receive the study drug(s) if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over after the end-of-study visit.
End-of-Study Visit:
About 28 days after your last dose of study drug, you will have an end-of-study visit:
- You will have a physical exam.
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
- You will have an EKG to check your heart function.
- You may have a bone marrow biopsy and/or aspirate to check the status of the disease.
- If you can become pregnant, blood (about 1 teaspoon) or urine will be collected for a pregnancy test.
If the End-of-Study Visit occurs within 21 days of your last dose, you will be called by a member of the study team about 30-37 days after your last dose of study drug. You will be asked how you are feeling and about any side effects you may be having. This call will last about 5 minutes.
This is an investigational study. Brentuximab vedotin is FDA approved and commercially available for the treatment of certain types of lymphoma after previous treatments have failed. Its use in combination with azacitidine is investigational. Azacytidine is FDA approved and commercially available for the treatment of myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML).
The study doctor can explain how the study drug(s) are designed to work.
Up to 61 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brentuximab Vedotin | Experimental | Drug: Brentuximab VedotinPilot Phase: Starting dose of Brentuximab Vedotin 1.2 mg/kg intravenous (IV) infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle (+/- 3 days). |
| Brentuximab Vedotin + 5-Azacytidine | Experimental | Drug: Brentuximab Vedotin, Drug: 5-AzacytidinePhase I Dose-Escalation Phase: Starting dose of Brentuximab Vedotin 1.0 mg/kg IV (starting dose level 1), or one-dose level lower than the established MTD if the pilot portion of the study establishes a lower MTD, infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle. All patients receive 5-azacytidine at 75 mg/m2/day by vein or subcutaneously on days 1-7 every 28 days. Phase II Dose-Expansion Phase: Patients receive Brentuximab Vedotin at MTD from dose-escalation phase by vein on Days 1, 8, and 15 of each 28-day cycle. Patients receive 5-Azacytidine at 75 mg/m2/day by vein or subcutaneously on days 1-7 every 28 days. Patients can receive up to a total of 12 cycles of treatment (weekly + monthly combined). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmed AML, other than acute promyelocytic leukemia, as defined by the 2008 World Health Organization (WHO) criteria that is relapsed or refractory to standard chemotherapy. Note: Newly-diagnosed AML patients who are 60 years or older and are not candidates for or have refused standard chemotherapy are also eligible for this trial.
- AML blasts must express CD30 (>/=10% expression as assessed by flow-cytometry or 2+ expression by immunohistochemistry) (whenever possible CD30 expression will be assessed by both methods)
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of </=3
- The following baseline laboratory data: Serum bilirubin </=1.5 x upper limit of normal (ULN) or </= 3 x ULN for patients with Gilbert's disease; Serum creatinine </=1.5 x ULN AND creatinine clearance >30 ml/min; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) </=3 x ULN
Key exclusion criteria (15 listed)
- History of another primary invasive malignancy that has not been definitively treated or in remission for at least 2 years. Patients with non-melanoma skin cancers or with carcinomas in situ are eligible regardless of the time from diagnosis (including concomitant diagnoses).
- Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association Class III-IV within 6 months prior to their first dose of brentuximab vedotin
- Evidence of active cerebral/meningeal disease. Patients may have history of central nervous system (CNS) leukemic involvement if definitively treated with prior therapy and no evidence of active disease at the time of registration.
- Previous treatment with any anti-CD30 directed therapy
- Patients with previous allogeneic stem cell transplant (SCT) if they meet either of the following criteria: <100 days from allogeneic SCT, Acute or chronic graft-versus-host disease (GvHD), or Receiving immunosuppressive therapy as treatment for or prophylaxis against GvHD within the last 7 days
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 |
|---|---|---|
| Brentuximab VedotinAlso: SGN-35, AdcetrisPilot Phase: Starting dose of Brentuximab Vedotin 1.2 mg/kg intravenous (IV) infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle. Phase I Dose-Escalation Phase: Starting dose of Brentuximab Vedotin 1.0 mg/kg IV (starting dose level 1), or one-dose level lower than the established MTD if the pilot portion of the study establishes a lower MTD, infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle. Phase II Dose-Expansion Phase: Patients receive Brentuximab Vedotin at MTD from dose-escalation phase by vein on Days 1, 8, and 15 of each 28-day cycle. | Drug | Brentuximab Vedotin, Brentuximab Vedotin + 5-Azacytidine |
| 5-AzacytidineAlso: Azacytidine, Azacitidine, 5-aza, VidazaPhase I Dose-Escalation Phase and Phase II Dose-Expansion Phase: 5-Azacytidine at 75 mg/m2/day by vein or subcutaneously on days 1-7 every 28 days. | Drug | Brentuximab Vedotin + 5-Azacytidine |
Primary outcome
Maximum Tolerated Dose (MTD) of Brentuximab Vedotin in Combination With 5-Azacytidine
Time frame: After 1, 28 day cycle
MTD defined as maximum dose at which <33% of patients experience a dose-limiting toxicity (DLT) during cycle 1.
Overall Response Rate
Time frame: Response assessed after four 28-day cycles, up to 120 days
Response defined as number of participants with complete response (CR), CR with incomplete platelet recovery (CRp), CR with insufficient hematological recovery (CRi) or partial remission (PR).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Nitin Jain, MBBS principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Brentuximab Vedotin and 5-Azacytidine in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
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 8 inclusion and 15 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 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 5 Sep 2017). 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?
Maximum Tolerated Dose (MTD) of Brentuximab Vedotin in Combination With 5-Azacytidine (time frame: After 1, 28 day cycle). The study lists 2 primary outcomes in all. 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 10 Oct 2023.