Vinblastine for Leukoreduction in Newly Diagnosed AML and Hyperleukocytosis

AML Clinical Trial

Official title:

Vinblastine Versus Oral Hydroxiurea in Newly Diagnosed AML With Hyperleukocytosis: a Phase 2 Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05062278
• Other study ID #: HE21-00019
• Status: Recruiting
• Phase: Phase 2
• Start date: July 26, 2021
• Est. completion date: December 1, 2025

Study information

• Verified date: October 2021
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: Andres Gomez
• Phone: 818470002
• Email: drgomezdeleon[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Vinblastine can leukoreduce patients with newly diagnosed AML and hyperleukocytosis but clinical trials are lacking.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: December 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age >18 years

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:

1. AML with PMP/RAR-alfa translocation t(15;17)

2. Poor functional status (ECOG>2)

3. Active infection

4. Pregnancy

Related Conditions & MeSH terms

• AML

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Mexico	Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer	Monterrey	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

References & Publications (5)

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. — View Citation

Mamez AC, Raffoux E, Chevret S, Lemiale V, Boissel N, Canet E, Schlemmer B, Dombret H, Azoulay E, Lengliné 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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).	5 days