Vinblastine for Leukoreduction in Newly Diagnosed AML and Hyperleukocytosis
NCT ID: NCT05062278
Last Updated: 2021-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
46 participants
INTERVENTIONAL
2021-07-26
2025-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intravenous Vinblastine
Single dose intravenous vinblastine (6mg/m2) in bolous.
Vinblastine
Single-dose of intravenous vinblastine at 6mg/m2 (maximum 10mg).
Oral Hydroxiurea
Patient will recieve oral hydroxiurea at a dose of 50mg/kg/day until response or administration of induction chemotherapy
Hydroxyurea capsules
Oral hydroxyurea at a dose of 50mg/kg/day until the administration of induction chemotherapy.
Interventions
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Vinblastine
Single-dose of intravenous vinblastine at 6mg/m2 (maximum 10mg).
Hydroxyurea capsules
Oral hydroxyurea at a dose of 50mg/kg/day until the administration of induction chemotherapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Both genders
3. Diagnosis of non-M3 AML by the WHO 2016 diagnostic criteria
4. Patients eligible and not eligible for transplant
5. Patients eligible and not eligible for intensive treatment
6. AML secondary to treatment or associated to myelodisplasia
7. Leukocytes ≥50x106/L
8. Not being able to receive chemotherapy in the next two days
Exclusion Criteria
2. Poor functional status (ECOG\>2)
3. Active infection
4. Pregnancy
18 Years
ALL
No
Sponsors
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Hospital Universitario Dr. Jose E. Gonzalez
OTHER
Responsible Party
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David Gomez Almaguer
Head of Hematology Department
Principal Investigators
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David Gomez
Role: PRINCIPAL_INVESTIGATOR
Universidad Autonoma de Nuevo Leon
Locations
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Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer
Monterrey, Nuevo León, Mexico
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Marbello 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.
Mamez 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.
Salerni 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.
Sauter 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.
Other Identifiers
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HE21-00019
Identifier Type: -
Identifier Source: org_study_id