Results From a Mexican Acute Promyelocytic Leukemia.

NCT04562818 | Completed DMC

• 1 other identifier: INCancerologiaMexico
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

Retrospective, observational study, comparing treatments of acute promyelocytic leukemia in different centers in México. There is no sufficient information about acute promyelocytic leukemia in America Latina, particularly in Mexico. For these reason the investigators started a study adding all promyelocityc patients from the main Hospital in Mexico in order to put together a group of patient and analyze the response, overall survival and what are the characteristics of the population. The investigators included 5 Hospital in Mexico City and states as Monterrey, Guadalajara, San Luis Potosi, Puebla, Veracruz, Yucatán, Oaxaca, Guanajuato, Estado de México. Even do, the investigators didn´t have arsenic trioxide they are treating patients with standard chemotherapy. These paper will help to show the authorities that the cost of treating patient with standard chemotherapy is much more higher than ATO-ATRA. The investigators are now doing a cost benefit analysis so the investigators, can soon have ATO treatment as standard of care in Mexico for the treatment of acute promyelocytic leukemia.

Conditions

Promyelocytic Leukemia, Acute

Outcome Measures

Primary Outcomes (1)

• Overall survival in Mexico in patients with acute promyelocytic leukemia

  Overall survival in different institutions in Mexico, in patient with diagnostic with acute promyelocytic leukemia

  January 2007- January 2017

Secondary Outcomes (2)

• Difference in survival with different anthracycline (Daunorrubicin vs idarrubicin)

  January 2007-January 2017

• Complications with different anthracycline

  January 2007-January 2017

Study Arms (2)

Daunorrubicin

Patient treated with daunorrubicin

Diagnostic Test: Diagnosis; Diagnostic Test: Molecular and Karyotype; Diagnostic Test: Leucocytes

Idarrubicin

Patient treated with idarrubicin

Diagnostic Test: Diagnosis; Diagnostic Test: Molecular and Karyotype; Diagnostic Test: Leucocytes

Interventions

Diagnosis DIAGNOSTIC_TEST

Determine the number of center that are able to process PCR or FISH/Karyotype for PML/RAR or t(15;17)

Daunorrubicin; Idarrubicin

Molecular and Karyotype DIAGNOSTIC_TEST

To realize the need of having more center we the technology to perform all of these tests

Also known as: FISH, Karyotype, PCR

Daunorrubicin; Idarrubicin

Leucocytes DIAGNOSTIC_TEST

Also known as: Risk status

Daunorrubicin; Idarrubicin

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patient older 15 years old with acute promyelocytic Leukemia treated at a Mecican Center

You may qualify if:

• Actute Promyelocytic leukemia PML/RAR alfa + Diabetes mellitus Hypertension Asthma Chronic renal disease

You may not qualify if:

• Non Acute Promyelocytic leukemia Younger than 15 years old

Sponsors & Collaborators

• Instituto Nacional de Cancerologia de Mexico: lead

Study Sites (1)

Nidia Zapata

Mexico City, Mexico City, 14080, Mexico

Location

Related Publications (17)

• Sanz MA, Fenaux P, Tallman MS, Estey EH, Lowenberg B, Naoe T, Lengfelder E, Dohner H, Burnett AK, Chen SJ, Mathews V, Iland H, Rego E, Kantarjian H, Ades L, Avvisati G, Montesinos P, Platzbecker U, Ravandi F, Russell NH, Lo-Coco F. Management of acute promyelocytic leukemia: updated recommendations from an expert panel of the European LeukemiaNet. Blood. 2019 Apr 11;133(15):1630-1643. doi: 10.1182/blood-2019-01-894980. Epub 2019 Feb 25.

  PMID: 30803991 RESULT

• Cicconi L, Fenaux P, Kantarjian H, Tallman M, Sanz MA, Lo-Coco F. Molecular remission as a therapeutic objective in acute promyelocytic leukemia. Leukemia. 2018 Aug;32(8):1671-1678. doi: 10.1038/s41375-018-0219-5. Epub 2018 Jul 19.

  PMID: 30026570 RESULT

• Ryan MM. Acute Promyelocytic Leukemia: A Summary. J Adv Pract Oncol. 2018 Mar;9(2):178-187. Epub 2018 Mar 1.

  PMID: 30588352 RESULT

• Warrell RP Jr, de The H, Wang ZY, Degos L. Acute promyelocytic leukemia. N Engl J Med. 1993 Jul 15;329(3):177-89. doi: 10.1056/NEJM199307153290307.

  PMID: 8515790 RESULT

• Barbui T, Finazzi G, Falanga A. The impact of all-trans-retinoic acid on the coagulopathy of acute promyelocytic leukemia. Blood. 1998 May 1;91(9):3093-102. No abstract available.

  PMID: 9558362 RESULT

• Tallman MS, Kwaan HC. Reassessing the hemostatic disorder associated with acute promyelocytic leukemia. Blood. 1992 Feb 1;79(3):543-53. No abstract available.

  PMID: 1732003 RESULT

• Fenaux P, Le Deley MC, Castaigne S, Archimbaud E, Chomienne C, Link H, Guerci A, Duarte M, Daniel MT, Bowen D, et al. Effect of all transretinoic acid in newly diagnosed acute promyelocytic leukemia. Results of a multicenter randomized trial. European APL 91 Group. Blood. 1993 Dec 1;82(11):3241-9.

  PMID: 8241496 RESULT

• Krutova TV, Linchina LP, Korman DB, Isaev NM, Shkrob OS. [Autoradiographic study of the gastric mucosa in cancer]. Vopr Onkol. 1976;22(10):8-13. Russian.

  PMID: 189506 RESULT

• Licht JD, Chomienne C, Goy A, Chen A, Scott AA, Head DR, Michaux JL, Wu Y, DeBlasio A, Miller WH Jr, et al. Clinical and molecular characterization of a rare syndrome of acute promyelocytic leukemia associated with translocation (11;17). Blood. 1995 Feb 15;85(4):1083-94.

  PMID: 7849296 RESULT

• Arber DA, Orazi A, Hasserjian R, et al. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016;127(20):2391-2405. Blood. 2016 Jul 21;128(3):462-463. doi: 10.1182/blood-2016-06-721662. No abstract available.

  PMID: 31659364 RESULT

• Avvisati G, Lo-Coco F, Paoloni FP, Petti MC, Diverio D, Vignetti M, Latagliata R, Specchia G, Baccarani M, Di Bona E, Fioritoni G, Marmont F, Rambaldi A, Di Raimondo F, Kropp MG, Pizzolo G, Pogliani EM, Rossi G, Cantore N, Nobile F, Gabbas A, Ferrara F, Fazi P, Amadori S, Mandelli F; GIMEMA, AIEOP, and EORTC Cooperative Groups. AIDA 0493 protocol for newly diagnosed acute promyelocytic leukemia: very long-term results and role of maintenance. Blood. 2011 May 5;117(18):4716-25. doi: 10.1182/blood-2010-08-302950. Epub 2011 Mar 8.

  PMID: 21385856 RESULT

• Powell BL, Moser B, Stock W, Gallagher RE, Willman CL, Stone RM, Rowe JM, Coutre S, Feusner JH, Gregory J, Couban S, Appelbaum FR, Tallman MS, Larson RA. Arsenic trioxide improves event-free and overall survival for adults with acute promyelocytic leukemia: North American Leukemia Intergroup Study C9710. Blood. 2010 Nov 11;116(19):3751-7. doi: 10.1182/blood-2010-02-269621. Epub 2010 Aug 12.

  PMID: 20705755 RESULT

• Platzbecker U, Avvisati G, Cicconi L, Thiede C, Paoloni F, Vignetti M, Ferrara F, Divona M, Albano F, Efficace F, Fazi P, Sborgia M, Di Bona E, Breccia M, Borlenghi E, Cairoli R, Rambaldi A, Melillo L, La Nasa G, Fiedler W, Brossart P, Hertenstein B, Salih HR, Wattad M, Lubbert M, Brandts CH, Hanel M, Rollig C, Schmitz N, Link H, Frairia C, Pogliani EM, Fozza C, D'Arco AM, Di Renzo N, Cortelezzi A, Fabbiano F, Dohner K, Ganser A, Dohner H, Amadori S, Mandelli F, Ehninger G, Schlenk RF, Lo-Coco F. Improved Outcomes With Retinoic Acid and Arsenic Trioxide Compared With Retinoic Acid and Chemotherapy in Non-High-Risk Acute Promyelocytic Leukemia: Final Results of the Randomized Italian-German APL0406 Trial. J Clin Oncol. 2017 Feb 20;35(6):605-612. doi: 10.1200/JCO.2016.67.1982. Epub 2016 Oct 31.

  PMID: 27400939 RESULT

• Hiorns LR, Swansbury GJ, Mehta J, Min T, Dainton MG, Treleaven J, Powles RL, Catovsky D. Additional chromosome abnormalities confer worse prognosis in acute promyelocytic leukaemia. Br J Haematol. 1997 Feb;96(2):314-21. doi: 10.1046/j.1365-2141.1997.d01-2037.x.

  PMID: 9029019 RESULT

• Iland HJ, Bradstock K, Supple SG, Catalano A, Collins M, Hertzberg M, Browett P, Grigg A, Firkin F, Hugman A, Reynolds J, Di Iulio J, Tiley C, Taylor K, Filshie R, Seldon M, Taper J, Szer J, Moore J, Bashford J, Seymour JF; Australasian Leukaemia and Lymphoma Group. All-trans-retinoic acid, idarubicin, and IV arsenic trioxide as initial therapy in acute promyelocytic leukemia (APML4). Blood. 2012 Aug 23;120(8):1570-80; quiz 1752. doi: 10.1182/blood-2012-02-410746. Epub 2012 Jun 19.

  PMID: 22715121 RESULT

• Grimwade D, Walker H, Oliver F, Wheatley K, Harrison C, Harrison G, Rees J, Hann I, Stevens R, Burnett A, Goldstone A. The importance of diagnostic cytogenetics on outcome in AML: analysis of 1,612 patients entered into the MRC AML 10 trial. The Medical Research Council Adult and Children's Leukaemia Working Parties. Blood. 1998 Oct 1;92(7):2322-33.

  PMID: 9746770 RESULT

• De Botton S, Chevret S, Sanz M, Dombret H, Thomas X, Guerci A, Fey M, Rayon C, Huguet F, Sotto JJ, Gardin C, Cony Makhoul P, Travade P, Solary E, Fegueux N, Bordessoule D, San Miguel J, Link H, Desablens B, Stamatoullas A, Deconinck E, Geiser K, Hess U, Maloisel F, Castaigne S, Preudhomme C, Chomienne C, Degos L, Fenaux P; European APL Group. Additional chromosomal abnormalities in patients with acute promyelocytic leukaemia (APL) do not confer poor prognosis: results of APL 93 trial. Br J Haematol. 2000 Dec;111(3):801-6. doi: 10.1046/j.1365-2141.2000.02442.x.

  PMID: 11122141 RESULT

MeSH Terms

Conditions

Leukemia, Promyelocytic, Acute

Interventions

Diagnosis; Karyotype; Leukocyte Count

Condition Hierarchy (Ancestors)

Leukemia, Myeloid, Acute; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Chromosomes; Genetic Structures; Genetic Phenomena; Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Hematology Department (Acute Myeloid Leukemia)

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: September 24, 2020
• Study Start: January 1, 2007
• Primary Completion: January 31, 2017
• Study Completion: January 1, 2018
• Last Updated: September 24, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)