Promyelocytic Leukemia, AcuteMexico APLNCT04562818
Results From a Mexican Acute Promyelocytic Leukemia.
An observational study of Promyelocytic Leukemia, Acute, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Promyelocytic Leukemia, Acute
- What is being tested?
- Diagnosis, Molecular and Karyotype and Leucocytes
- How many people
- 360 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jan 2007to 1 Jan 2018
- Phase
- Observational
- 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 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patient older 15 years old with acute promyelocytic Leukemia treated at a Mecican Center
Who may be able to join
- Actute Promyelocytic leukemia PML/RAR alfa + Diabetes mellitus Hypertension Asthma Chronic renal disease
Who cannot join
- Non Acute Promyelocytic leukemia Younger than 15 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Results From a Mexican Long-term Multicentric Study on Acute Promyelocytic Leukemia.
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.
Read more
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.
Read the detailed description
A multicentric, retrospective, descriptive, longitudinal study was carried out. Between January 2007 and January 2017, patients of both sexes and different ages, who were candidates for receiving intensive chemotherapy along with tretinoin were included in the study. The diagnosis for Acute Promyelocytic Leukemia was determined based on the following criteria: abnormal promyelocytes in the bone marrow and verification of the t(15;17) translocation by karyotype or using RT-PCR to determine the genetic lesion and define the type of PML/RARA isoform.
In Mexico the investigators still treating patients with anthracycline and cytarabine + transretinoic acid. These information will help the authorities to realize the importance of having arsenic trioxide as part of the treatment of these disease, knowing the amount of patient that the investigators have in Mexico, knowing that in the hispanic race the incidence is greater.
- Conditions
- Promyelocytic Leukemia, Acute
- Being tested
- Diagnosis, Molecular and Karyotype, Leucocytes
- Medical subject headings
- Leukemia, Promyelocytic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiagnosisDiagnostic test
Determine the number of center that are able to process PCR or FISH/Karyotype for PML/RAR or t(15;17)
Molecular and KaryotypeDiagnostic test
Also called FISH, Karyotype, PCR
To realize the need of having more center we the technology to perform all of these tests
LeucocytesDiagnostic test
Also called Risk status
| Study group | Role | What they receive |
|---|---|---|
| Daunorrubicin | Patient treated with daunorrubicin Receives: Diagnostic Test: Diagnosis; Diagnostic Test: Molecular and Karyotype; Diagnostic Test: Leucocytes | |
| Idarrubicin | Patient treated with idarrubicin Receives: Diagnostic Test: Diagnosis; Diagnostic Test: Molecular and Karyotype; Diagnostic Test: Leucocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: January 2007- January 2017
Secondary outcomes (2)
Difference in survival with different anthracycline (Daunorrubicin vs idarrubicin)
Event free survival and overall survival with different anthracyclin
Measured: January 2007-January 2017
Complications with different anthracycline
Complications
Measured: January 2007-January 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 Jan 2007
- Primary completion31 Jan 2017
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Promyelocytic Leukemia, AcuteStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancerologia de Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nidia Paulina Zapata-Canto, Instituto Nacional de Cancerologia de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562818
- Sponsor's protocol ID
- INCancerologiaMexico
- Acronym
- Mexico APL
- Status last verified
- Sep 2020
- First submitted
- 8 Jun 2020
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan is to published the information in Mexico, so we can start planing with the Mexican government the cost of treating a patient with Chemotherapy vs ATO/ATRA
Publications
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.
PubMed 30803991Cicconi 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.
PubMed 30026570Ryan MM. Acute Promyelocytic Leukemia: A Summary. J Adv Pract Oncol. 2018 Mar;9(2):178-187. Epub 2018 Mar 1.
PubMed 30588352Warrell 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.
PubMed 8515790Barbui 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.
PubMed 9558362Tallman MS, Kwaan HC. Reassessing the hemostatic disorder associated with acute promyelocytic leukemia. Blood. 1992 Feb 1;79(3):543-53. No abstract available.
PubMed 1732003Fenaux 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.
PubMed 8241496Krutova 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.
PubMed 189506Licht 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.
PubMed 7849296Arber 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.
PubMed 31659364Avvisati 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.
PubMed 21385856Powell 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.
PubMed 20705755Platzbecker 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.
PubMed 27400939Hiorns 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.
PubMed 9029019Iland 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.
PubMed 22715121
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results From a Mexican Long-term Multicentric Study on Acute Promyelocytic Leukemia.
- ClinicalTrials.gov ID
- NCT04562818
- Acronym / sponsor ID
- Mexico APL / INCancerologiaMexico
- Conditions
- Promyelocytic Leukemia, Acute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Instituto Nacional de Cancerologia de MexicoUniversity, hospital or other
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 24 Sep 2020 (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.
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.
Detailed description
A multicentric, retrospective, descriptive, longitudinal study was carried out. Between January 2007 and January 2017, patients of both sexes and different ages, who were candidates for receiving intensive chemotherapy along with tretinoin were included in the study. The diagnosis for Acute Promyelocytic Leukemia was determined based on the following criteria: abnormal promyelocytes in the bone marrow and verification of the t(15;17) translocation by karyotype or using RT-PCR to determine the genetic lesion and define the type of PML/RARA isoform.
In Mexico the investigators still treating patients with anthracycline and cytarabine + transretinoic acid. These information will help the authorities to realize the importance of having arsenic trioxide as part of the treatment of these disease, knowing the amount of patient that the investigators have in Mexico, knowing that in the hispanic race the incidence is greater.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daunorrubicin | – | Diagnostic Test: Diagnosis, Diagnostic Test: Molecular and Karyotype, Diagnostic Test: LeucocytesPatient treated with daunorrubicin |
| Idarrubicin | – | Diagnostic Test: Diagnosis, Diagnostic Test: Molecular and Karyotype, Diagnostic Test: LeucocytesPatient treated with idarrubicin |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patient older 15 years old with acute promyelocytic Leukemia treated at a Mecican Center
Key inclusion criteria (1 listed)
- Actute Promyelocytic leukemia PML/RAR alfa + Diabetes mellitus Hypertension Asthma Chronic renal disease
Key exclusion criteria (1 listed)
- Non Acute Promyelocytic leukemia Younger than 15 years old
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 |
|---|---|---|
| DiagnosisDetermine the number of center that are able to process PCR or FISH/Karyotype for PML/RAR or t(15;17) | Diagnostic test | Daunorrubicin, Idarrubicin |
| Molecular and KaryotypeAlso: FISH, Karyotype, PCRTo realize the need of having more center we the technology to perform all of these tests | Diagnostic test | Daunorrubicin, Idarrubicin |
| LeucocytesAlso: Risk status | Diagnostic test | Daunorrubicin, Idarrubicin |
Primary outcome
Overall survival in Mexico in patients with acute promyelocytic leukemia
Time frame: January 2007- January 2017
Overall survival in different institutions in Mexico, in patient with diagnostic with acute promyelocytic leukemia
2 secondary outcomes
Difference in survival with different anthracycline (Daunorrubicin vs idarrubicin)
Time frame: January 2007-January 2017
Complications with different anthracycline
Time frame: January 2007-January 2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Results publication: PubMed 30803991Sanz 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.
- Results publication: PubMed 30026570Cicconi 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.
- Results publication: PubMed 30588352Ryan MM. Acute Promyelocytic Leukemia: A Summary. J Adv Pract Oncol. 2018 Mar;9(2):178-187. Epub 2018 Mar 1.
- Results publication: PubMed 8515790Warrell 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.
- Results publication: PubMed 9558362Barbui 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.
- Results publication: PubMed 1732003Tallman MS, Kwaan HC. Reassessing the hemostatic disorder associated with acute promyelocytic leukemia. Blood. 1992 Feb 1;79(3):543-53. No abstract available.
- Results publication: PubMed 8241496Fenaux 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.
- Results publication: PubMed 189506Krutova 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.
- Results publication: PubMed 7849296Licht 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.
- Results publication: PubMed 31659364Arber 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.
- Results publication: PubMed 21385856Avvisati 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.
- Results publication: PubMed 20705755Powell 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.
- Individual participant dataSharing planned: No. Plan is to published the information in Mexico, so we can start planing with the Mexican government the cost of treating a patient with Chemotherapy vs ATO/ATRA
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Promyelocytic Leukemia, Acute, run by Instituto Nacional de Cancerologia de Mexico 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Sep 2020. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival in Mexico in patients with acute promyelocytic leukemia (time frame: January 2007- January 2017). 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 NCT04562818, which also lists 17 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 24 Sep 2020.