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Vinblastine can leukoreduce patients with newly diagnosed AML and hyperleukocytosis but clinical trials are lacking.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Vinblastine | Experimental | Single dose intravenous vinblastine (6mg/m2) in bolous. |
|
| Oral Hydroxiurea | Active Comparator | Patient will recieve oral hydroxiurea at a dose of 50mg/kg/day until response or administration of induction chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vinblastine | Drug | Single-dose of intravenous vinblastine at 6mg/m2 (maximum 10mg). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 days |
| Time to achieve a significant reduction in leukocyte count by complete blood count |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andres Gomez | Contact | 818470002 | drgomezdeleon@gmail.com | |
| Perla Colunga | Contact | colunga.perla@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| David Gomez | Universidad Autonoma de Nuevo Leon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer | Recruiting | Monterrey | Nuevo León | 64460 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25303497 | Background | 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. | |
| 18313749 |
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| ID | Term |
|---|---|
| D014747 | Vinblastine |
| D006918 | Hydroxyurea |
| ID | Term |
|---|---|
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
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Patients with newly diagnose AML will be allocated 1:1 to recieve single dose vinblastine or daily oral hydroxiurea
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| Hydroxyurea capsules | Drug | Oral hydroxyurea at a dose of 50mg/kg/day until the administration of induction chemotherapy. |
|
Document time for effective leukoreduction by complete blood count after each intervention (defined as a reduction of >50% of leukocytes after intervention). |
| 5 days |
| Background |
| 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. |
| 26849624 | Background | 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. |
| 20371726 | Background | 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. |
| 6961036 | Background | 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. |
| D006571 |
| Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |