Acute Lymphoblastic LeukemiaPhase 2/3PTX-IINCT02451774
Pentoxifylline In Pediatric Acute Lymphoblastic Leukemia During Induction
A Phase 2/3 study testing Pentoxifylline Plus Chemotherapy in people with Acute Lymphoblastic Leukemia, run by Ramón Óscar González-Ramella, Ph.D at 1 site in Mexico.
Trial summary
Recent advances in acute lymphoblastic leukemia treatment are based on a cytotoxic drug combination. Measurement of minimal residual disease in bone marrow samples at day 14 of treatment is the most powerful early predictive indicator of further relapse, and it can be applied practically to all patients with acute… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Pentoxifylline Plus Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2015to Dec 2020
- Phase
- Phase 2/3
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric and teenaged patients of both genders ≤18 years of age with newly diagnosed acute lymphoblastic leukemia in accordance with French-American-British criteria and under immunophenotypical classification and paired within the risk-classification group.
- Patients with ≥20 kg of weight at the time of treatment assignment.
- Patients who are able to swallow the medicine
- Patients agreeing to enter the protocol by the signing of informed consent by the parent
- Patients who could give their assent to enter the protocol
- The parent or guardian must be able to read.
Who cannot join
- Patients with treatment adherence of ≥80 percent
- Patients or their parents who decide to abandon the study or who withdraw consent for participation
- Patients who present grade III or higher adverse event.
- Patients previously treated with chemotherapy and/or radiotherapy
- History of peptic acid disease or gastrointestinal bleeding
- Known pentoxifylline intolerance and general intolerance to xanthine, caffeine or theophylline
Show all 12Show fewer
- Patients in treatment with anticoagulants, Cimetidine, Ciprofloxacin, or Theophylline
- Patients with Down syndrome
- Patients with several bleeding or extensive retinal hemorrhage, several cardiac arrhythmias (paroxysmal supraventricular tachycardia, congenital atrioventricular block, arrhythmias associated with congenital heart disease, digital poisoning, and patients after cardiac surgery, hypoxia, hypercapnia, and electrolyte disturbances)
- Patients with hypotension
- Several liver failures
- Bleeding diathesis (for bleeding disorders or anticoagulant medication)
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Civil de Guadalajara "Dr. Juan I. Menchaca"
Guadalajara, Jalisco, 44340
Ramon O Gonzalez Ramella, PhD, 5213331719826, glezramella@hotmail.com
Fabiola P Medina Barajas, PhD, 5213313461917, favyri@hotmail.com
About this study
Official title: SAFETY AND EFFICACY OF PENTOXIFYLLINE VERSUS PLACEBO ADMINISTERED AS APOPTOSIS INDUCTOR DURING REMISSION INDUCTION PHASE OF PEDIATRIC PATIENTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA
Recent advances in acute lymphoblastic leukemia treatment are based on a cytotoxic drug combination. Measurement of minimal residual disease in bone marrow samples at day 14 of treatment is the most powerful early predictive indicator of further relapse, and it can be applied practically to all patients with acute lymphoblastic leukemia. Even more so, it has been observed that patients who present negative minimal residual disease in bone marrow samples at day 7 during induction have a better prognosis than those achieving this at day 14.
Relapse represents the main cause of treatment failure that related in the extreme with resistance to apoptosis, defining the latter as the principal mechanism of programmed cell death; it is also related with the induction of leukemic cells to senescent arrest.
Read more
Pentoxifylline is a methyl-xanthine byproduct considered an unspecific inhibitor of phosphodiesterase. It inhibits nuclear factor-kappa-beta activation by different mechanisms and stimulates apoptosis induced by different drugs; thus, it can optimize the antineoplastic effect of actual treatments in order to increase the apoptosis of leukemic cells. This effect might improve the prognosis of these patients.
Evaluate the safety and effect of Pentoxifylline together with antineoplastic drugs in order to study increased apoptosis and decreased senescence during the remission induction phase in pediatric patients with newly diagnosed acute lymphoblastic leukemia. To achieve this propose, we will divide patients in two groups, who will receive pentoxifylline or placebo depending on the group, in addition to conventional treatment according to the protocol standard chemotherapy schema for pediatric patients with acute lymphoblastic leukemia at our institution during the remission induction phase. In addition, we will test whether the study group exerts an impact on reaching remission earlier as compared with the control group.
Read the detailed description
This study will be controlled, double-blind clinical trial versus placebo, with random assignment to evaluate the effect of pentoxifylline on apoptosis and senescence of leukemic blasts from remission induction in pediatric patients with newly diagnosed acute lymphoblastic leukemia, as well as to address pentoxifylline efficacy and safety in this group of patients.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Pentoxifylline Plus Chemotherapy, Placebo Plus Chemotherapy
- Keywords
- pediatric, apoptosis
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentoxifylline Plus ChemotherapyDrug
Also called Oxpentifylline
Pentoxifylline 10 to 20 milligrams per kilogram, daily, for up to 32 days Chemotherapy: Prednisone 40 milligrams per square meter per day, orally, day 5-32. Vincristine 1.5 milligrams per square meter per week, intravenously, day 5, 12, 19, 26. Daunorubicin 25 milligrams per square meter per week, intravenously, days 5; 12. L-asparaginase 10,000 units for square meter, intramuscular, days 6, 8, 10, 12, 14, 16, 19, 21, 23. Cyclophosphamide 1000 milligrams per square meter per dose intravenously, day 26. Cytarabine 75 milligrams per square meter per dose intravenously, days 27-30, 34-37. 6-Mercaptopurine 60 milligrams per square meter per dose, orally, days 26-39, Mix: Methotrexate 8-12 milligrams, Hydrocortisone 16-24 milligrams and Cytarabine 24-36 milligrams, intrathecal, day 19.
Placebo Plus ChemotherapyDrug
Also called Placebo
Placebo daily, for up to 32 days Chemotherapy: Prednisone 40 milligrams per square meter per day, orally, day 5-32. Vincristine 1.5 milligrams per square meter per week, intravenously, day 5, 12, 19, 26. Daunorubicin 25 milligrams per square meter per week, intravenously, days 5; 12. L-asparaginase 10,000 units for square meter, intramuscular, days 6, 8, 10, 12, 14, 16, 19, 21, 23. Cyclophosphamide 1000 milligrams per square meter per dose intravenously, day 26. Cytarabine 75 milligrams per square meter per dose intravenously, days 27-30, 34-37. 6-Mercaptopurine 60 milligrams per square meter per dose, orally, days 26-39, Mix: Methotrexate 8-12 milligrams, Hydrocortisone 16-24 milligrams and Cytarabine 24-36 milligrams, intrathecal, day 19.
| Study group | Role | What they receive |
|---|---|---|
| Pentoxifylline Plus Chemotherapy | Experimental | Pentoxifylline: 10-20 milligrams per kilogram, doses daily by oral, for 30 days.
Chemotherapy: Prednisone, Vincristine, Daunorubicin, L-asparaginase, Cyclophosphamide, Cytarabine, 6-Mercaptopurine, Methotrexate, Hydrocortisone and Cytarabine Receives: Drug: Pentoxifylline Plus Chemotherapy |
| Placebo Plus Chemotherapy | Placebo comparator | Placebo: double blind period, one doses daily for 30 days. Chemotherapy: Prednisone, Vincristine, Daunorubicin, L-asparaginase, Cyclophosphamide, Cytarabine, 6-Mercaptopurine, Methotrexate, Hydrocortisone and Cytarabine Receives: Drug: Placebo Plus Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apoptosis measure by Flow Cytometry
Percentage of apoptotic cells by Flow Cytometry
Measured: Up to 28 days after initiation of chemotherapy for remission induction
Secondary outcomes (2)
Senescence measure by Flow Cytometry
Percentage of senescent blasts by Flow Cytometry
Measured: Up to 28 days after initiation of chemotherapy for remission induction.
Safety measure by Common Terminology Criteria for Adverse Events version 4.0
Percentage of adverse events grading table is a list of common terms and severity (intensity) of parameters used to describe adverse events occurring in Common Terminology Criteria for Adverse Events version 4.0
Measured: Evaluate frequency adverse events with pentoxifylline up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic LeukemiaStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ramón Óscar González-Ramella, Ph.D
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigacion en Cancer de la Infancia y la Adolescencia, Hospital Civil Juan I. Menchaca, Centro de Investigacion Biomedica de Occidente
- Responsible party
- Sponsor-investigator, Ramón Óscar González-Ramella, Ph.D, University of Guadalajara
- Investigators
- Ramón O. Gonzalez Ramella, PhD, Principal investigator, Instituto de Investigacion de Cancer de la Infancia y la Adolescencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451774
- Sponsor's protocol ID
- IICIA -PTX02
- Acronym
- PTX-II
- Status last verified
- May 2018
- First submitted
- 9 Feb 2015
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Makishima H, Visconte V, Sakaguchi H, Jankowska AM, Abu Kar S, Jerez A, Przychodzen B, Bupathi M, Guinta K, Afable MG, Sekeres MA, Padgett RA, Tiu RV, Maciejewski JP. Mutations in the spliceosome machinery, a novel and ubiquitous pathway in leukemogenesis. Blood. 2012 Apr 5;119(14):3203-10. doi: 10.1182/blood-2011-12-399774. Epub 2012 Feb 9.
PubMed 22323480Dores GM, Devesa SS, Curtis RE, Linet MS, Morton LM. Acute leukemia incidence and patient survival among children and adults in the United States, 2001-2007. Blood. 2012 Jan 5;119(1):34-43. doi: 10.1182/blood-2011-04-347872. Epub 2011 Nov 15.
PubMed 22086414Perez-Saldivar ML, Fajardo-Gutierrez A, Bernaldez-Rios R, Martinez-Avalos A, Medina-Sanson A, Espinosa-Hernandez L, Flores-Chapa Jde D, Amador-Sanchez R, Penaloza-Gonzalez JG, Alvarez-Rodriguez FJ, Bolea-Murga V, Flores-Lujano J, Rodriguez-Zepeda Mdel C, Rivera-Luna R, Dorantes-Acosta EM, Jimenez-Hernandez E, Alvarado-Ibarra M, Velazquez-Avina MM, Torres-Nava JR, Duarte-Rodriguez DA, Paredes-Aguilera R, Del Campo-Martinez Mde L, Cardenas-Cardos R, Alamilla-Galicia PH, Bekker-Mendez VC, Ortega-Alvarez MC, Mejia-Arangure JM. Childhood acute leukemias are frequent in Mexico City: descriptive epidemiology. BMC Cancer. 2011 Aug 17;11:355. doi: 10.1186/1471-2407-11-355.
PubMed 21846410Belson M, Kingsley B, Holmes A. Risk factors for acute leukemia in children: a review. Environ Health Perspect. 2007 Jan;115(1):138-45. doi: 10.1289/ehp.9023.
PubMed 17366834Pui CH, Robison LL, Look AT. Acute lymphoblastic leukaemia. Lancet. 2008 Mar 22;371(9617):1030-43. doi: 10.1016/S0140-6736(08)60457-2.
PubMed 18358930Pui CH, Carroll WL, Meshinchi S, Arceci RJ. Biology, risk stratification, and therapy of pediatric acute leukemias: an update. J Clin Oncol. 2011 Feb 10;29(5):551-65. doi: 10.1200/JCO.2010.30.7405. Epub 2011 Jan 10.
PubMed 21220611Wong RS. Apoptosis in cancer: from pathogenesis to treatment. J Exp Clin Cancer Res. 2011 Sep 26;30(1):87. doi: 10.1186/1756-9966-30-87.
PubMed 21943236Herr I, Debatin KM. Cellular stress response and apoptosis in cancer therapy. Blood. 2001 Nov 1;98(9):2603-14. doi: 10.1182/blood.v98.9.2603.
PubMed 11675328Campisi J. Aging, cellular senescence, and cancer. Annu Rev Physiol. 2013;75:685-705. doi: 10.1146/annurev-physiol-030212-183653. Epub 2012 Nov 8.
PubMed 23140366Sankari SL, Masthan KM, Babu NA, Bhattacharjee T, Elumalai M. Apoptosis in cancer--an update. Asian Pac J Cancer Prev. 2012;13(10):4873-8. doi: 10.7314/apjcp.2012.13.10.4873.
PubMed 23244073Chauhan PS, Bhushan B, Singh LC, Mishra AK, Saluja S, Mittal V, Gupta DK, Kapur S. Expression of genes related to multiple drug resistance and apoptosis in acute leukemia: response to induction chemotherapy. Exp Mol Pathol. 2012 Feb;92(1):44-9. doi: 10.1016/j.yexmp.2011.09.004. Epub 2011 Oct 19.
PubMed 22037714Reuter S, Gupta SC, Kannappan R, Aggarwal BB. WITHDRAWN: Evidence for the critical roles of NF-kappaB p65 and specificity proteins in the apoptosis-inducing activity of proteasome inhibitors in leukemia cells. Biochim Biophys Acta. 2012 Jan 10:10.1016/j.bbadis.2012.01.002. doi: 10.1016/j.bbadis.2012.01.002. Online ahead of print.
PubMed 22265847Hernandez-Flores G, Ortiz-Lazareno PC, Lerma-Diaz JM, Dominguez-Rodriguez JR, Jave-Suarez LF, Aguilar-Lemarroy Adel C, de Celis-Carrillo R, del Toro-Arreola S, Castellanos-Esparza YC, Bravo-Cuellar A. Pentoxifylline sensitizes human cervical tumor cells to cisplatin-induced apoptosis by suppressing NF-kappa B and decreased cell senescence. BMC Cancer. 2011 Nov 10;11:483. doi: 10.1186/1471-2407-11-483.
PubMed 22074157Armstrong SA, Look AT. Molecular genetics of acute lymphoblastic leukemia. J Clin Oncol. 2005 Sep 10;23(26):6306-15. doi: 10.1200/JCO.2005.05.047.
PubMed 16155013Salceda-Rivera V, Ortiz-Lazareno PC, Hernandez-Flores G, Vazquez-Urrutia JR, Meza-Arroyo J, Pardo-Zepeda M, Romo-Rubio H, Barba-Barba C, Sanchez-Zubieta F, Barron-Gallardo CA, Gonzalez-Ramella O, Bravo-Cuellar A. Very early remission and increased apoptosis with the use of Pentoxifylline in children with acute lymphoblastic leukemia. Front Oncol. 2024 Oct 3;14:1401262. doi: 10.3389/fonc.2024.1401262. eCollection 2024.
PubMed 39421449
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAFETY AND EFFICACY OF PENTOXIFYLLINE VERSUS PLACEBO ADMINISTERED AS APOPTOSIS INDUCTOR DURING REMISSION INDUCTION PHASE OF PEDIATRIC PATIENTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA
- ClinicalTrials.gov ID
- NCT02451774
- Acronym / sponsor ID
- PTX-II / IICIA -PTX02
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- pediatric, apoptosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Ramón Óscar González-Ramella, Ph.DUniversity, hospital or other
- Collaborators
- Instituto de Investigacion en Cancer de la Infancia y la Adolescencia, Hospital Civil Juan I. Menchaca, Centro de Investigacion Biomedica de Occidente
- Study start
- Jan 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 22 May 2015 (estimated)
- 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.
Recent advances in acute lymphoblastic leukemia treatment are based on a cytotoxic drug combination. Measurement of minimal residual disease in bone marrow samples at day 14 of treatment is the most powerful early predictive indicator of further relapse, and it can be applied practically to all patients with acute lymphoblastic leukemia. Even more so, it has been observed that patients who present negative minimal residual disease in bone marrow samples at day 7 during induction have a better prognosis than those achieving this at day 14.
Relapse represents the main cause of treatment failure that related in the extreme with resistance to apoptosis, defining the latter as the principal mechanism of programmed cell death; it is also related with the induction of leukemic cells to senescent arrest.
Pentoxifylline is a methyl-xanthine byproduct considered an unspecific inhibitor of phosphodiesterase. It inhibits nuclear factor-kappa-beta activation by different mechanisms and stimulates apoptosis induced by different drugs; thus, it can optimize the antineoplastic effect of actual treatments in order to increase the apoptosis of leukemic cells. This effect might improve the prognosis of these patients.
Evaluate the safety and effect of Pentoxifylline together with antineoplastic drugs in order to study increased apoptosis and decreased senescence during the remission induction phase in pediatric patients with newly diagnosed acute lymphoblastic leukemia. To achieve this propose, we will divide patients in two groups, who will receive pentoxifylline or placebo depending on the group, in addition to conventional treatment according to the protocol standard chemotherapy schema for pediatric patients with acute lymphoblastic leukemia at our institution during the remission induction phase. In addition, we will test whether the study group exerts an impact on reaching remission earlier as compared with the control group.
Detailed description
This study will be controlled, double-blind clinical trial versus placebo, with random assignment to evaluate the effect of pentoxifylline on apoptosis and senescence of leukemic blasts from remission induction in pediatric patients with newly diagnosed acute lymphoblastic leukemia, as well as to address pentoxifylline efficacy and safety in this group of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pentoxifylline Plus Chemotherapy | Experimental | Drug: Pentoxifylline Plus ChemotherapyPentoxifylline: 10-20 milligrams per kilogram, doses daily by oral, for 30 days. Chemotherapy: Prednisone, Vincristine, Daunorubicin, L-asparaginase, Cyclophosphamide, Cytarabine, 6-Mercaptopurine, Methotrexate, Hydrocortisone and Cytarabine |
| Placebo Plus Chemotherapy | Placebo comparator | Drug: Placebo Plus ChemotherapyPlacebo: double blind period, one doses daily for 30 days. Chemotherapy: Prednisone, Vincristine, Daunorubicin, L-asparaginase, Cyclophosphamide, Cytarabine, 6-Mercaptopurine, Methotrexate, Hydrocortisone and Cytarabine |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Pediatric and teenaged patients of both genders ≤18 years of age with newly diagnosed acute lymphoblastic leukemia in accordance with French-American-British criteria and under immunophenotypical classification and paired within the risk-classification group.
- Patients with ≥20 kg of weight at the time of treatment assignment.
- Patients who are able to swallow the medicine
- Patients agreeing to enter the protocol by the signing of informed consent by the parent
- Patients who could give their assent to enter the protocol
Key exclusion criteria (12 listed)
- Patients with treatment adherence of ≥80 percent
- Patients or their parents who decide to abandon the study or who withdraw consent for participation
- Patients who present grade III or higher adverse event.
- Patients previously treated with chemotherapy and/or radiotherapy
- History of peptic acid disease or gastrointestinal bleeding
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 |
|---|---|---|
| Pentoxifylline Plus ChemotherapyAlso: OxpentifyllinePentoxifylline 10 to 20 milligrams per kilogram, daily, for up to 32 days Chemotherapy: Prednisone 40 milligrams per square meter per day, orally, day 5-32. Vincristine 1.5 milligrams per square meter per week, intravenously, day 5, 12, 19, 26. Daunorubicin 25 milligrams per square meter per week, intravenously, days 5; 12. L-asparaginase 10,000 units for square meter, intramuscular, days 6, 8, 10, 12, 14, 16, 19, 21, 23. Cyclophosphamide 1000 milligrams per square meter per dose intravenously, day 26. Cytarabine 75 milligrams per square meter per dose intravenously, days 27-30, 34-37. 6-Mercaptopurine 60 milligrams per square meter per dose, orally, days 26-39, Mix: Methotrexate 8-12 milligrams, Hydrocortisone 16-24 milligrams and Cytarabine 24-36 milligrams, intrathecal, day 19. | Drug | Pentoxifylline Plus Chemotherapy |
| Placebo Plus ChemotherapyAlso: PlaceboPlacebo daily, for up to 32 days Chemotherapy: Prednisone 40 milligrams per square meter per day, orally, day 5-32. Vincristine 1.5 milligrams per square meter per week, intravenously, day 5, 12, 19, 26. Daunorubicin 25 milligrams per square meter per week, intravenously, days 5; 12. L-asparaginase 10,000 units for square meter, intramuscular, days 6, 8, 10, 12, 14, 16, 19, 21, 23. Cyclophosphamide 1000 milligrams per square meter per dose intravenously, day 26. Cytarabine 75 milligrams per square meter per dose intravenously, days 27-30, 34-37. 6-Mercaptopurine 60 milligrams per square meter per dose, orally, days 26-39, Mix: Methotrexate 8-12 milligrams, Hydrocortisone 16-24 milligrams and Cytarabine 24-36 milligrams, intrathecal, day 19. | Drug | Placebo Plus Chemotherapy |
Primary outcome
Apoptosis measure by Flow Cytometry
Time frame: Up to 28 days after initiation of chemotherapy for remission induction
Percentage of apoptotic cells by Flow Cytometry
2 secondary outcomes
Senescence measure by Flow Cytometry
Time frame: Up to 28 days after initiation of chemotherapy for remission induction.
Safety measure by Common Terminology Criteria for Adverse Events version 4.0
Time frame: Evaluate frequency adverse events with pentoxifylline up to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Results publication: PubMed 22323480Makishima H, Visconte V, Sakaguchi H, Jankowska AM, Abu Kar S, Jerez A, Przychodzen B, Bupathi M, Guinta K, Afable MG, Sekeres MA, Padgett RA, Tiu RV, Maciejewski JP. Mutations in the spliceosome machinery, a novel and ubiquitous pathway in leukemogenesis. Blood. 2012 Apr 5;119(14):3203-10. doi: 10.1182/blood-2011-12-399774. Epub 2012 Feb 9.
- Results publication: PubMed 22086414Dores GM, Devesa SS, Curtis RE, Linet MS, Morton LM. Acute leukemia incidence and patient survival among children and adults in the United States, 2001-2007. Blood. 2012 Jan 5;119(1):34-43. doi: 10.1182/blood-2011-04-347872. Epub 2011 Nov 15.
- Results publication: PubMed 21846410Perez-Saldivar ML, Fajardo-Gutierrez A, Bernaldez-Rios R, Martinez-Avalos A, Medina-Sanson A, Espinosa-Hernandez L, Flores-Chapa Jde D, Amador-Sanchez R, Penaloza-Gonzalez JG, Alvarez-Rodriguez FJ, Bolea-Murga V, Flores-Lujano J, Rodriguez-Zepeda Mdel C, Rivera-Luna R, Dorantes-Acosta EM, Jimenez-Hernandez E, Alvarado-Ibarra M, Velazquez-Avina MM, Torres-Nava JR, Duarte-Rodriguez DA, Paredes-Aguilera R, Del Campo-Martinez Mde L, Cardenas-Cardos R, Alamilla-Galicia PH, Bekker-Mendez VC, Ortega-Alvarez MC, Mejia-Arangure JM. Childhood acute leukemias are frequent in Mexico City: descriptive epidemiology. BMC Cancer. 2011 Aug 17;11:355. doi: 10.1186/1471-2407-11-355.
- Results publication: PubMed 17366834Belson M, Kingsley B, Holmes A. Risk factors for acute leukemia in children: a review. Environ Health Perspect. 2007 Jan;115(1):138-45. doi: 10.1289/ehp.9023.
- Results publication: PubMed 18358930Pui CH, Robison LL, Look AT. Acute lymphoblastic leukaemia. Lancet. 2008 Mar 22;371(9617):1030-43. doi: 10.1016/S0140-6736(08)60457-2.
- Results publication: PubMed 21220611Pui CH, Carroll WL, Meshinchi S, Arceci RJ. Biology, risk stratification, and therapy of pediatric acute leukemias: an update. J Clin Oncol. 2011 Feb 10;29(5):551-65. doi: 10.1200/JCO.2010.30.7405. Epub 2011 Jan 10.
- Results publication: PubMed 21943236Wong RS. Apoptosis in cancer: from pathogenesis to treatment. J Exp Clin Cancer Res. 2011 Sep 26;30(1):87. doi: 10.1186/1756-9966-30-87.
- Results publication: PubMed 11675328Herr I, Debatin KM. Cellular stress response and apoptosis in cancer therapy. Blood. 2001 Nov 1;98(9):2603-14. doi: 10.1182/blood.v98.9.2603.
- Results publication: PubMed 23140366Campisi J. Aging, cellular senescence, and cancer. Annu Rev Physiol. 2013;75:685-705. doi: 10.1146/annurev-physiol-030212-183653. Epub 2012 Nov 8.
- Results publication: PubMed 23244073Sankari SL, Masthan KM, Babu NA, Bhattacharjee T, Elumalai M. Apoptosis in cancer--an update. Asian Pac J Cancer Prev. 2012;13(10):4873-8. doi: 10.7314/apjcp.2012.13.10.4873.
- Results publication: PubMed 22037714Chauhan PS, Bhushan B, Singh LC, Mishra AK, Saluja S, Mittal V, Gupta DK, Kapur S. Expression of genes related to multiple drug resistance and apoptosis in acute leukemia: response to induction chemotherapy. Exp Mol Pathol. 2012 Feb;92(1):44-9. doi: 10.1016/j.yexmp.2011.09.004. Epub 2011 Oct 19.
- Results publication: PubMed 22265847Reuter S, Gupta SC, Kannappan R, Aggarwal BB. WITHDRAWN: Evidence for the critical roles of NF-kappaB p65 and specificity proteins in the apoptosis-inducing activity of proteasome inhibitors in leukemia cells. Biochim Biophys Acta. 2012 Jan 10:10.1016/j.bbadis.2012.01.002. doi: 10.1016/j.bbadis.2012.01.002. Online ahead of print.
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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.
Ramón O. Gonzalez Ramella, PhD principal investigator
Instituto de Investigacion de Cancer de la Infancia y la Adolescencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pentoxifylline Plus Chemotherapy in people with Acute Lymphoblastic Leukemia, run by Ramón Óscar González-Ramella, Ph.D 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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 9 May 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monzerrat Pardo Zepeda, MD (+5213311946817, monzepardo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apoptosis measure by Flow Cytometry (time frame: Up to 28 days after initiation of chemotherapy for remission induction). 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 NCT02451774, which also lists 15 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 9 May 2018.