AMLPhase 2NCT05062278
Vinblastine for Leukoreduction in Newly Diagnosed AML and Hyperleukocytosis
A Phase 2 study testing Vinblastine and Hydroxyurea capsules in people with AML and Hyperleukocytosis, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial summary
Vinblastine can leukoreduce patients with newly diagnosed AML and hyperleukocytosis but clinical trials are lacking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML, Hyperleukocytosis
- What is being tested?
- Vinblastine and Hydroxyurea capsules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteMexico
- Study dates
- 26 Jul 2021to 1 Dec 2025
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Both genders
- Diagnosis of non-M3 AML by the WHO 2016 diagnostic criteria
- Patients eligible and not eligible for transplant
- Patients eligible and not eligible for intensive treatment
- AML secondary to treatment or associated to myelodisplasia
- Leukocytes ≥50x106/L
- Not being able to receive chemotherapy in the next two days
Who cannot join
- AML with PMP/RAR-alfa translocation t(15;17)
- Poor functional status (ECOG>2)
- Active infection
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Perla Colunga contact
Mexico1 site, 1 recruiting
- Recruiting
Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer
Monterrey, Nuevo León, 64460
David Gomez-Almaguer, MD, +52 81 8348-8510, dgomezalmaguer@gmail.com
Andres Gomez, MD, 818470002, drgomezdeleon@gmail.com
About this study
Official title: Vinblastine Versus Oral Hydroxiurea in Newly Diagnosed AML With Hyperleukocytosis: a Phase 2 Clinical Study
Vinblastine can leukoreduce patients with newly diagnosed AML and hyperleukocytosis but clinical trials are lacking.
Read the detailed description
This phase 2 trial will explore the efficacy of a single dose of vinblastine (6mg/m2) to leukoreduce patients with newly diagnosed AML and hyperleukocytosis. Patients will be allocated 1:1 into two groups: intravenous single dose vinblastine or oral hydroxiurea (50mg/kg/day until response or induction chemotherapy). Effective leukoreduction and safety parameters will be compared.
- Conditions
- AML, Hyperleukocytosis
- Being tested
- Vinblastine, Hydroxyurea capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VinblastineDrug
Also called Blestinib
Single-dose of intravenous vinblastine at 6mg/m2 (maximum 10mg).
Hydroxyurea capsulesDrug
Oral hydroxyurea at a dose of 50mg/kg/day until the administration of induction chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Vinblastine | Experimental | Single dose intravenous vinblastine (6mg/m2) in bolous. Receives: Drug: Vinblastine |
| Oral Hydroxiurea | Active comparator | Patient will recieve oral hydroxiurea at a dose of 50mg/kg/day until response or administration of induction chemotherapy Receives: Drug: Hydroxyurea capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with a significant reduction in the number of leukocytes by complete blood count
The proportion of patients with a reduction in the number of leukocytes higher than 50% by complete blood count at 48 hours after the intervention.
Measured: 2 days
Secondary outcomes (2)
Description of daily leukocytes by complete blood count after intervention
Document daily changes in the number of leukocytes by complete blood count after the administration of intravenous vinblastine or oral hydroxyurea.
Measured: 5 days
Time to achieve a significant reduction in leukocyte count by complete blood count
Document time for effective leukoreduction by complete blood count after each intervention (defined as a reduction of >50% of leukocytes after intervention).
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start26 Jul 2021
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AMLStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients with newly diagnose AML will be allocated 1:1 to recieve single dose vinblastine or daily oral hydroxiurea
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez
- Investigators
- David Gomez, Principal investigator, Universidad Autonoma de Nuevo Leon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062278
- Sponsor's protocol ID
- HE21-00019
- Status last verified
- Oct 2021
- First submitted
- 26 Jul 2021
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kuo KH, Callum JL, Panzarella T, Jacks LM, Brandwein J, Crump M, Curtis JE, Gupta V, Lipton JH, Minden MD, Sher GD, Schimmer AD, Schuh AC, Yee KW, Keating A, Messner HA. A retrospective observational study of leucoreductive strategies to manage patients with acute myeloid leukaemia presenting with hyperleucocytosis. Br J Haematol. 2015 Feb;168(3):384-94. doi: 10.1111/bjh.13146. Epub 2014 Oct 10.
PubMed 25303497Marbello L, Ricci F, Nosari AM, Turrini M, Nador G, Nichelatti M, Tedeschi A, Vismara E, Morra E. Outcome of hyperleukocytic adult acute myeloid leukaemia: a single-center retrospective study and review of literature. Leuk Res. 2008 Aug;32(8):1221-7. doi: 10.1016/j.leukres.2008.01.004. Epub 2008 Mar 3.
PubMed 18313749Mamez AC, Raffoux E, Chevret S, Lemiale V, Boissel N, Canet E, Schlemmer B, Dombret H, Azoulay E, Lengline E. Pre-treatment with oral hydroxyurea prior to intensive chemotherapy improves early survival of patients with high hyperleukocytosis in acute myeloid leukemia. Leuk Lymphoma. 2016 Oct;57(10):2281-8. doi: 10.3109/10428194.2016.1142083. Epub 2016 Feb 5.
PubMed 26849624Salerni BL, Bates DJ, Albershardt TC, Lowrey CH, Eastman A. Vinblastine induces acute, cell cycle phase-independent apoptosis in some leukemias and lymphomas and can induce acute apoptosis in others when Mcl-1 is suppressed. Mol Cancer Ther. 2010 Apr;9(4):791-802. doi: 10.1158/1535-7163.MCT-10-0028. Epub 2010 Apr 6.
PubMed 20371726Sauter C, Fehr J, Frick P, Gmuer J, Honegger H, Martz G. Acute myelogenous leukemia: successful treatment of relapse with cytosine arabinoside, VP 16-213, vincristine and vinblastine (A-triple-V). Eur J Cancer Clin Oncol. 1982 Aug;18(8):733-7. doi: 10.1016/0277-5379(82)90071-2.
PubMed 6961036
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vinblastine Versus Oral Hydroxiurea in Newly Diagnosed AML With Hyperleukocytosis: a Phase 2 Clinical Study
- ClinicalTrials.gov ID
- NCT05062278
- Acronym / sponsor ID
- HE21-00019
- Conditions
- AML, Hyperleukocytosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 30 Sep 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.
Vinblastine can leukoreduce patients with newly diagnosed AML and hyperleukocytosis but clinical trials are lacking.
Detailed description
This phase 2 trial will explore the efficacy of a single dose of vinblastine (6mg/m2) to leukoreduce patients with newly diagnosed AML and hyperleukocytosis. Patients will be allocated 1:1 into two groups: intravenous single dose vinblastine or oral hydroxiurea (50mg/kg/day until response or induction chemotherapy). Effective leukoreduction and safety parameters will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with newly diagnose AML will be allocated 1:1 to recieve single dose vinblastine or daily oral hydroxiurea
| Arm | Type | Receives |
|---|---|---|
| Intravenous Vinblastine | Experimental | Drug: VinblastineSingle dose intravenous vinblastine (6mg/m2) in bolous. |
| Oral Hydroxiurea | Active comparator | Drug: Hydroxyurea capsulesPatient will recieve oral hydroxiurea at a dose of 50mg/kg/day until response or administration of induction chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age >18 years
- Both genders
- Diagnosis of non-M3 AML by the WHO 2016 diagnostic criteria
- Patients eligible and not eligible for transplant
- Patients eligible and not eligible for intensive treatment
Key exclusion criteria (4 listed)
- AML with PMP/RAR-alfa translocation t(15;17)
- Poor functional status (ECOG>2)
- Active infection
- Pregnancy
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 |
|---|---|---|
| VinblastineAlso: BlestinibSingle-dose of intravenous vinblastine at 6mg/m2 (maximum 10mg). | Drug | Intravenous Vinblastine |
| Hydroxyurea capsulesOral hydroxyurea at a dose of 50mg/kg/day until the administration of induction chemotherapy. | Drug | Oral Hydroxiurea |
Primary outcome
The proportion of patients with a significant reduction in the number of leukocytes by complete blood count
Time frame: 2 days
The proportion of patients with a reduction in the number of leukocytes higher than 50% by complete blood count at 48 hours after the intervention.
2 secondary outcomes
Description of daily leukocytes by complete blood count after intervention
Time frame: 5 days
Time to achieve a significant reduction in leukocyte count by complete blood count
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Background: PubMed 25303497Kuo KH, Callum JL, Panzarella T, Jacks LM, Brandwein J, Crump M, Curtis JE, Gupta V, Lipton JH, Minden MD, Sher GD, Schimmer AD, Schuh AC, Yee KW, Keating A, Messner HA. A retrospective observational study of leucoreductive strategies to manage patients with acute myeloid leukaemia presenting with hyperleucocytosis. Br J Haematol. 2015 Feb;168(3):384-94. doi: 10.1111/bjh.13146. Epub 2014 Oct 10.
- Background: PubMed 18313749Marbello L, Ricci F, Nosari AM, Turrini M, Nador G, Nichelatti M, Tedeschi A, Vismara E, Morra E. Outcome of hyperleukocytic adult acute myeloid leukaemia: a single-center retrospective study and review of literature. Leuk Res. 2008 Aug;32(8):1221-7. doi: 10.1016/j.leukres.2008.01.004. Epub 2008 Mar 3.
- Background: PubMed 26849624Mamez AC, Raffoux E, Chevret S, Lemiale V, Boissel N, Canet E, Schlemmer B, Dombret H, Azoulay E, Lengline E. Pre-treatment with oral hydroxyurea prior to intensive chemotherapy improves early survival of patients with high hyperleukocytosis in acute myeloid leukemia. Leuk Lymphoma. 2016 Oct;57(10):2281-8. doi: 10.3109/10428194.2016.1142083. Epub 2016 Feb 5.
- Background: PubMed 20371726Salerni BL, Bates DJ, Albershardt TC, Lowrey CH, Eastman A. Vinblastine induces acute, cell cycle phase-independent apoptosis in some leukemias and lymphomas and can induce acute apoptosis in others when Mcl-1 is suppressed. Mol Cancer Ther. 2010 Apr;9(4):791-802. doi: 10.1158/1535-7163.MCT-10-0028. Epub 2010 Apr 6.
- Background: PubMed 6961036Sauter C, Fehr J, Frick P, Gmuer J, Honegger H, Martz G. Acute myelogenous leukemia: successful treatment of relapse with cytosine arabinoside, VP 16-213, vincristine and vinblastine (A-triple-V). Eur J Cancer Clin Oncol. 1982 Aug;18(8):733-7. doi: 10.1016/0277-5379(82)90071-2.
- 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.
Perla Colunga contact
David Gomez principal investigator
Universidad Autonoma de Nuevo Leon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vinblastine and Hydroxyurea capsules in people with AML and Hyperleukocytosis, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
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 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: status not confirmed, as of the sponsor's last update on 18 Oct 2021. 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 Mexico. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andres Gomez (818470002, drgomezdeleon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with a significant reduction in the number of leukocytes by complete blood count (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05062278, which also lists 5 linked publications.
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 18 Oct 2021.