Leukemia, Myeloid, AcutePhase 1VICTORYNCT05005299
Venetoclax in Combination With Non-myeloablative Conditioning Allogeneic Haematopoietic Stem Cell Transplantation
A Phase 1 study testing Venetoclax, Fludarabine and Cyclophosphamide in people with Leukemia, Myeloid, Acute and Leukemia, Lymphoblastic, Acute, L1, run by Melbourne Health at 1 site in Australia.
Trial summary
This is a Phase 1, open-label, single center study of short-course oral venetoclax therapy prior to non-myeloablative conditioning with fludarabine and cyclophosphamide in subjects with haematological malignancies who are planned for allogeneic stem cell transplantation (alloSCT). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Leukemia, Myeloid, Acute, Leukemia, Lymphoblastic, Acute, L1, Leukemia, Lymphoblastic, Acute, L2
- What is being tested?
- Venetoclax, Fludarabine and Cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteAustralia
- Study dates
- 8 Jun 2022to 31 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are eligible for inclusion if all of the following criteria are met:
- Age ≥ 18 years
- Planned to undergo alloSCT for one of the following haematological malignancies: acute leukaemia (including myeloid and/or lymphoid lineage or biphenotypic), myelodysplastic syndrome, chronic lymphocytic leukaemia (CLL), B-cell non-Hodgkin lymphoma (NHL) and plasma cell myeloma
- Physician preference for a non-myeloablative conditioning regimen
- Available 10/10 HLA-matched related or unrelated haematopoietic stem cell donor
- Transplantation to be performed from a peripheral blood stem cell source
Show all 18Show fewer
- Adequate renal and hepatic function at screening as follows:
- Calculated creatinine clearance >50ml/min as measured by Cockroft Gault formula
- AST and ALT ≤ 3.0 x ULN
- Bilirubin ≤ 1.5 x ULN (except patients with Gilbert's Syndrome)
- Able to tolerate oral medications
- Disease status at the time of transplantation as follows:
- Acute leukaemia in complete morphologic remission
- Myelodysplastic syndrome with less than 10% bone marrow blasts
- CLL in complete remission (CR), partial response (PR) or PR with lymphocytosis
- NHL in CR or PR
- Myeloma in CR, very good partial response (VGPR) or PR within 3 months of prior autologous stem cell transplantation as part of a tandem auto-allo transplant approach
- ECOG performance status 0-1
Who cannot join
- Patients will be excluded from this study if any of the following criteria are met:
- Moderate or high risk of tumour lysis syndrome prior to conditioning for allogeneic transplantation, defined as:
- For CLL: Diameter of any lymph node or tumour mass >5cm OR absolute lymphocyte count≥25x10^9/L
- For NHL: Diameter of any lymph node or tumour mass >5cm
- Prior intolerance of venetoclax or another BCL-2 inhibitor with the exception of cytopenias. Patients with prior clinical tumour lysis syndrome following venetoclax or other BCL-2 inhibitor will be excluded from the study if at the time of prior TLS their disease burden was as follows:
- For CLL: Diameter of any lymph node or tumour mass <5cm OR absolute lymphocyte count≤25x10^9/L
Show all 17Show fewer
- For NHL: Diameter of any lymph node or tumour mass <5cm
- Reticulin fibrosis of the marrow of grade MF 2-3
- Prior allogeneic stem cell transplantation
- Haemopoietic cell transplantation - comorbidity index (HCT-CI) score > 5
- Any currently active malignancy other than the primary indication for alloSCT (except localized basal cell carcinoma or squamous cell carcinoma of the skin)
- Uncontrolled systemic infection
- Known malabsorption syndrome
- Has received within 7 days prior to the first dose of venetoclax CYP3A4 inducers such as rifampicin, carbamazepine, phenytoin and St John's wort
- Has received within 7 days prior to the first dose of venetoclax CYP3A4 inhibitors
- Known positivity to HIV
- Significant physical or psychiatric comorbid illness that in the investigator's opinion would impair the patient's ability to participate in the study.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Melbourne Health
Melbourne, Victoria, 3050
David Ritchie, MBBS, PhD, +61393427000, David.Ritchie@mh.org.au
David Ritchie, MBBS, PhD
About this study
Official title: The VICTORY Study: A Phase I Study of Venetoclax in Combination With Non-myeloablative Conditioning Allogeneic Haematopoietic Stem Cell Transplantation
This is a Phase 1, open-label, single center study of short-course oral venetoclax therapy prior to non-myeloablative conditioning with fludarabine and cyclophosphamide in subjects with haematological malignancies who are planned for allogeneic stem cell transplantation (alloSCT). The primary study objective is to determine the safety and maximum tolerated dose of venetoclax when used in combination with fludarabine and cyclophosphamide conditioning. Secondary objectives were to evaluate the transplant outcomes and donor/recipient engraftment of this regimen.
Read the detailed description
Eligible patients are to be enrolled sequentially into one of 4 treatment Dose Levels (beginning with Dose Level A) to receive short-course venetoclax on day -11 to -6, followed by intravenous fludarabine 30mg/m2 daily (day -5 to -3) and intravenous cyclophosphamide 750mg/m2 daily (day -5 to -3). Allogeneic stem cell infusion will occur on day 0. In the dose-escalation phase of this 3+3 study, three patients are planned for each Dose Level.
Dose Level A: venetoclax 100mg daily administered on day -11 to -6 (total venetoclax dose: 600mg)
Dose Level B: venetoclax 100mg daily administered on day -11, followed by 200mg daily administered on day -10 to -6 (total venetoclax dose: 1100mg)
Dose Level C: venetoclax 100mg daily administered on day -11, followed by 200mg daily administered on day -10, 400mg daily administered on day -9 and 600mg daily administered on day -8 to -6 (total venetoclax dose: 2500mg)
Protocol-specific dose-limiting toxicitues (DLTs) will be assessed from the first dose of venetoclax up to day 30 post-transplant. Subjects will not be treated in a new cohort until all subjects in the previous cohort had completed the DLT evaluation period and ≤ 1 of 6 subjects had experienced a DLT. If ≥ 2 of 6 subjects experienced a DLT at Dose Level C, subjects will be treated at Dose B' as part of the dose-escalation phase of this study.
Dose Level B': venetoclax 100mg daily administered on day -11, followed by 200mg daily administered on day -10 and 400mg daily administered on day -9 to -6 (total venetoclax dose: 1900mg)
The maximum tolerated dose (MTD) is defined as the highest Dose Level at which ≤ 1 of 6 subjects had experienced a DLT. The dose-expansion phase involves recruitment of up to 12 patients at the MTD.
- Conditions
- Leukemia, Myeloid, Acute, Leukemia, Lymphoblastic, Acute, L1, Leukemia, Lymphoblastic, Acute, L2, Myelodysplastic Syndromes, Non-hodgkin Lymphoma, Plasma Cell Myeloma
- Being tested
- Venetoclax, Fludarabine, Cyclophosphamide
- Keywords
- Venetoclax, Reduced intensity conditioning, Non-myeloablative conditioning, Allogeneic stem cell transplant, Acute leukemia, Myelodysplastic syndrome, Non-Hodgkin Lymphoma, Plasma Cell Myeloma, Graft-versus-host Disease, Engraftment, Graft-versus-Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes, Lymphoma, Non-Hodgkin, Multiple Myeloma, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
Also called Venclaxta
Venetoclax is administered as an oral tablet once daily.
FludarabineDrug
Fludarabine is administered as an intravenous infusion at a dose of 30mg/m2 daily, to be administered over 30 minutes.
CyclophosphamideDrug
Cyclophosphamide is administered as an intravenous infusion at a dose of 750mg/m2 daily, to be administered over 30 minutes and to commence 1 hour after fludarabine infusion.
| Study group | Role | What they receive |
|---|---|---|
| Dose Level A | Experimental | Subjects will receive receive short-course venetoclax on day -11 to -6 [venetoclax 100mg daily administered on day -11 to -6 (total venetoclax dose: 600mg)], followed by intravenous fludarabine 30mg/m2 daily (day -5 to -3) and intravenous cyclophosphamide 750mg/m2 daily (day -5 to -3). Allogeneic stem cell infusion will occur on day 0. Receives: Drug: Venetoclax; Drug: Fludarabine; Drug: Cyclophosphamide |
| Dose Level B | Experimental | Subjects will receive receive short-course venetoclax on day -11 to -6 [venetoclax 100mg daily administered on day -11, followed by 200mg daily administered on day -10 to -6 (total venetoclax dose: 1100mg)], followed by intravenous fludarabine 30mg/m2 daily (day -5 to -3) and intravenous cyclophosphamide 750mg/m2 daily (day -5 to -3). Allogeneic stem cell infusion will occur on day 0. Receives: Drug: Venetoclax; Drug: Fludarabine; Drug: Cyclophosphamide |
| Dose Level C | Experimental | Subjects will receive receive short-course venetoclax on day -11 to -6 [venetoclax 100mg daily administered on day -11, followed by 200mg daily administered on day -10, 400mg daily administered on day -9 and 600mg daily administered on day -8 to -6 (total venetoclax dose: 2500mg)], followed by intravenous fludarabine 30mg/m2 daily (day -5 to -3) and intravenous cyclophosphamide 750mg/m2 daily (day -5 to -3). Allogeneic stem cell infusion will occur on day 0. Receives: Drug: Venetoclax; Drug: Fludarabine; Drug: Cyclophosphamide |
| Dose Level B' | Experimental | Subjects will receive receive short-course venetoclax on day -11 to -6 [venetoclax 100mg daily administered on day -11, followed by 200mg daily administered on day -10 and 400mg daily administered on day -9 to -6 (total venetoclax dose: 1900mg)], followed by intravenous fludarabine 30mg/m2 daily (day -5 to -3) and intravenous cyclophosphamide 750mg/m2 daily (day -5 to -3). Allogeneic stem cell infusion will occur on day 0. Receives: Drug: Venetoclax; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The development of any dose-limiting toxicities
Dose-limiting toxicities (DLT), defined as any of the following which cannot be clearly attributed to a concurrent illness, concomitant medication or those expected as part of standard allogeneic stem cell transplant (alloSCT) complications:
- Any grade 3-4 non-haematological adverse events between day -11 to day -1
- Primary failure of neutrophil engraftment by day 30 post-alloSCT. The date of neutrophil engraftment is defined as the first of 3 consecutive days of neutrophil count ≥ 0.5 x 10^9/L.
- Primary failure of platelet engraftment by day 30 post-alloSCT. The date of platelet engraftment is defined as the first day of platelet count ≥ 20 x 10^9/L, with no transfusions for at least 7 days prior.
- Grade 3-4 acute graft-versus-host disease (GVHD) prior to day 30 post-alloSCT
- Development of Clinical Tumour Lysis Syndrome
Measured: Time point between time of first dose of venetoclax to day 30 post-alloSCT
Secondary outcomes (5)
Acute GVHD incidence and severity
Acute GVHD (grade 1-4 and grade 3-4) is classified according to the Przepiorka criteria
Measured: 180 days post allo-SCT
Chronic GVHD incidence and severity
Chronic GVHD (mild, moderate or severe) is classified according to the Filipovich criteria
Measured: 1-year post-alloSCT
GVHD, relapse-free survival (GRFS) incidence
GRFS is defined as freedom from grade 3-4 acute GVHD, systemic therapy-requiring chronic GVHD, relapse or death in the first year following alloSCT
Measured: 1-year post-alloSCT
Relapse and non-relapse mortality incidence
Relapse is defined as recurrence of disease, determined by radiological or histological grounds.
Non-relapse mortality is defined as all-cause mortality without recurrence or progressive disease following alloSCT.
Measured: 1-year post-alloSCT
Donor/recipient chimerism
Myeloid and T-cell chimerism by fragment analysis and capillary electrophoresis of shor tandem repeat markers.
Measured: Measured at days 30, 60, 100, 1 year and 2 years following alloSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start8 Jun 2022
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase 1 study, 3+3 design with dose expansion phase.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Melbourne Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Ritchie, Principal investigator, Melbourne Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005299
- Sponsor's protocol ID
- 2021.238
- Acronym
- VICTORY
- Status last verified
- Jun 2023
- First submitted
- 8 Aug 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The VICTORY Study: A Phase I Study of Venetoclax in Combination With Non-myeloablative Conditioning Allogeneic Haematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT05005299
- Acronym / sponsor ID
- VICTORY / 2021.238
- Conditions
- Leukemia, Myeloid, Acute, Leukemia, Lymphoblastic, Acute, L1, Leukemia, Lymphoblastic, Acute, L2, Myelodysplastic Syndromes, Non-hodgkin Lymphoma, Plasma Cell Myeloma
- Keywords
- Venetoclax, Reduced intensity conditioning, Non-myeloablative conditioning, Allogeneic stem cell transplant, Acute leukemia, Myelodysplastic syndrome, Non-Hodgkin Lymphoma, Plasma Cell Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Melbourne HealthUniversity, hospital or other
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, open-label, single center study of short-course oral venetoclax therapy prior to non-myeloablative conditioning with fludarabine and cyclophosphamide in subjects with haematological malignancies who are planned for allogeneic stem cell transplantation (alloSCT). The primary study objective is to determine the safety and maximum tolerated dose of venetoclax when used in combination with fludarabine and cyclophosphamide conditioning. Secondary objectives were to evaluate the transplant outcomes and donor/recipient engraftment of this regimen.
Detailed description
Eligible patients are to be enrolled sequentially into one of 4 treatment Dose Levels (beginning with Dose Level A) to receive short-course venetoclax on day -11 to -6, followed by intravenous fludarabine 30mg/m2 daily (day -5 to -3) and intravenous cyclophosphamide 750mg/m2 daily (day -5 to -3). Allogeneic stem cell infusion will occur on day 0. In the dose-escalation phase of this 3+3 study, three patients are planned for each Dose Level.
Dose Level A: venetoclax 100mg daily administered on day -11 to -6 (total venetoclax dose: 600mg)
Dose Level B: venetoclax 100mg daily administered on day -11, followed by 200mg daily administered on day -10 to -6 (total venetoclax dose: 1100mg)
Dose Level C: venetoclax 100mg daily administered on day -11, followed by 200mg daily administered on day -10, 400mg daily administered on day -9 and 600mg daily administered on day -8 to -6 (total venetoclax dose: 2500mg)
Protocol-specific dose-limiting toxicitues (DLTs) will be assessed from the first dose of venetoclax up to day 30 post-transplant. Subjects will not be treated in a new cohort until all subjects in the previous cohort had completed the DLT evaluation period and ≤ 1 of 6 subjects had experienced a DLT. If ≥ 2 of 6 subjects experienced a DLT at Dose Level C, subjects will be treated at Dose B' as part of the dose-escalation phase of this study.
Dose Level B': venetoclax 100mg daily administered on day -11, followed by 200mg daily administered on day -10 and 400mg daily administered on day -9 to -6 (total venetoclax dose: 1900mg)
The maximum tolerated dose (MTD) is defined as the highest Dose Level at which ≤ 1 of 6 subjects had experienced a DLT. The dose-expansion phase involves recruitment of up to 12 patients at the MTD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Phase 1 study, 3+3 design with dose expansion phase.
| Arm | Type | Receives |
|---|---|---|
| Dose Level A | Experimental | Drug: Venetoclax, Drug: Fludarabine, Drug: CyclophosphamideSubjects will receive receive short-course venetoclax on day -11 to -6 [venetoclax 100mg daily administered on day -11 to -6 (total venetoclax dose: 600mg)], followed by intravenous fludarabine 30mg/m2 daily (day -5 to -3) and intravenous cyclophosphamide 750mg/m2 daily (day -5 to -3). Allogeneic stem cell infusion will occur on day 0. |
| Dose Level B | Experimental | Drug: Venetoclax, Drug: Fludarabine, Drug: CyclophosphamideSubjects will receive receive short-course venetoclax on day -11 to -6 [venetoclax 100mg daily administered on day -11, followed by 200mg daily administered on day -10 to -6 (total venetoclax dose: 1100mg)], followed by intravenous fludarabine 30mg/m2 daily (day -5 to -3) and intravenous cyclophosphamide 750mg/m2 daily (day -5 to -3). Allogeneic stem cell infusion will occur on day 0. |
| Dose Level C | Experimental | Drug: Venetoclax, Drug: Fludarabine, Drug: CyclophosphamideSubjects will receive receive short-course venetoclax on day -11 to -6 [venetoclax 100mg daily administered on day -11, followed by 200mg daily administered on day -10, 400mg daily administered on day -9 and 600mg daily administered on day -8 to -6 (total venetoclax dose: 2500mg)], followed by intravenous fludarabine 30mg/m2 daily (day -5 to -3) and intravenous cyclophosphamide 750mg/m2 daily (day -5 to -3). Allogeneic stem cell infusion will occur on day 0. |
| Dose Level B' | Experimental | Drug: Venetoclax, Drug: Fludarabine, Drug: CyclophosphamideSubjects will receive receive short-course venetoclax on day -11 to -6 [venetoclax 100mg daily administered on day -11, followed by 200mg daily administered on day -10 and 400mg daily administered on day -9 to -6 (total venetoclax dose: 1900mg)], followed by intravenous fludarabine 30mg/m2 daily (day -5 to -3) and intravenous cyclophosphamide 750mg/m2 daily (day -5 to -3). Allogeneic stem cell infusion will occur on day 0. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age ≥ 18 years
- Planned to undergo alloSCT for one of the following haematological malignancies: acute leukaemia (including myeloid and/or lymphoid lineage or biphenotypic), myelodysplastic syndrome, chronic lymphocytic leukaemia (CLL), B-cell non-Hodgkin lymphoma (NHL) and plasma cell myeloma
- Physician preference for a non-myeloablative conditioning regimen
- Available 10/10 HLA-matched related or unrelated haematopoietic stem cell donor
- Transplantation to be performed from a peripheral blood stem cell source
Key exclusion criteria (17 listed)
- Moderate or high risk of tumour lysis syndrome prior to conditioning for allogeneic transplantation, defined as:
- Prior intolerance of venetoclax or another BCL-2 inhibitor with the exception of cytopenias. Patients with prior clinical tumour lysis syndrome following venetoclax or other BCL-2 inhibitor will be excluded from the study if at the time of prior TLS their disease burden was as follows:
- Reticulin fibrosis of the marrow of grade MF 2-3
- Prior allogeneic stem cell transplantation
- Haemopoietic cell transplantation - comorbidity index (HCT-CI) score > 5
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 |
|---|---|---|
| VenetoclaxAlso: VenclaxtaVenetoclax is administered as an oral tablet once daily. | Drug | Dose Level A, Dose Level B, Dose Level B', Dose Level C |
| FludarabineFludarabine is administered as an intravenous infusion at a dose of 30mg/m2 daily, to be administered over 30 minutes. | Drug | Dose Level A, Dose Level B, Dose Level B', Dose Level C |
| CyclophosphamideCyclophosphamide is administered as an intravenous infusion at a dose of 750mg/m2 daily, to be administered over 30 minutes and to commence 1 hour after fludarabine infusion. | Drug | Dose Level A, Dose Level B, Dose Level B', Dose Level C |
Primary outcome
The development of any dose-limiting toxicities
Time frame: Time point between time of first dose of venetoclax to day 30 post-alloSCT
Dose-limiting toxicities (DLT), defined as any of the following which cannot be clearly attributed to a concurrent illness, concomitant medication or those expected as part of standard allogeneic stem cell transplant (alloSCT) complications: * Any grade 3-4 non-haematological adverse events between day -11 to day -1 * Primary failure of neutrophil engraftment by day 30 post-alloSCT. The date of neutrophil engraftment is defined as the first of 3 consecutive days of neutrophil count ≥ 0.5 x 10^9/L. * Primary failure of platelet engraftment by day 30 post-alloSCT. The date of platelet engraftment is defined as the first day of platelet count ≥ 20 x 10^9/L, with no transfusions for at least 7 days prior. * Grade 3-4 acute graft-versus-host disease (GVHD) prior to day 30 post-alloSCT * Development of Clinical Tumour Lysis Syndrome
5 secondary outcomes
Acute GVHD incidence and severity
Time frame: 180 days post allo-SCT
Chronic GVHD incidence and severity
Time frame: 1-year post-alloSCT
GVHD, relapse-free survival (GRFS) incidence
Time frame: 1-year post-alloSCT
Relapse and non-relapse mortality incidence
Time frame: 1-year post-alloSCT
Donor/recipient chimerism
Time frame: Measured at days 30, 60, 100, 1 year and 2 years following alloSCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Leukemia, Myeloid, Acute
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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.
David Ritchie principal investigator
Melbourne Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Venetoclax, Fludarabine and Cyclophosphamide in people with Leukemia, Myeloid, Acute and Leukemia, Lymphoblastic, Acute, L1, run by Melbourne Health at 1 site in Australia.
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 18 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 1 Aug 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 Australia. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Ritchie (+61393427000, David.Ritchie@mh.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The development of any dose-limiting toxicities (time frame: Time point between time of first dose of venetoclax to day 30 post-alloSCT). 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 1 Aug 2023.