Pentoxifylline In Pediatric Acute Lymphoblastic Leukemia During Induction

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Brief Title

Pentoxifylline In Pediatric Acute Lymphoblastic Leukemia During Induction

Official Title

SAFETY AND EFFICACY OF PENTOXIFYLLINE VERSUS PLACEBO ADMINISTERED AS APOPTOSIS INDUCTOR DURING REMISSION INDUCTION PHASE OF PEDIATRIC PATIENTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA

Brief 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 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 Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Apoptosis measure by Flow Cytometry

Secondary Outcome

 Senescence measure by Flow Cytometry

Condition

Acute Lymphoblastic Leukemia

Intervention

Pentoxifylline Plus Chemotherapy

Study Arms / Comparison Groups

 Pentoxifylline Plus Chemotherapy
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

44

Start Date

January 2015

Completion Date

December 2020

Primary Completion Date

December 2019

Eligibility Criteria

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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

          -  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)
      

Gender

All

Ages

1 Year - 18 Years

Accepts Healthy Volunteers

No

Contacts

Ramón O. Gonzalez Ramella, PhD, +5213311946817, [email protected]

Location Countries

Mexico

Location Countries

Mexico

Administrative Informations


NCT ID

NCT02451774

Organization ID

IICIA -PTX02


Responsible Party

Sponsor-Investigator

Study Sponsor

Ramón Óscar González-Ramella, Ph.D

Collaborators

 Instituto de Investigacion en Cancer de la Infancia y la Adolescencia

Study Sponsor

Ramón O. Gonzalez Ramella, PhD, Principal Investigator, Instituto de Investigacion de Cancer de la Infancia y la Adolescencia


Verification Date

May 2018