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NCT01720264

Multicenter Phase II of CD26 Using Sitagliptin for Engraftment After UBC Transplant

Completed Phase 2 Results posted Last updated 8 January 2019
What this trial tests

Phase 2 trial testing Sitagliptin in Acute Myeloid Leukemia in 15 participants. Completed in 15 December 2017.

Timeline
2 November 2012
Primary endpoint
27 August 2016
15 December 2017

Quick facts

Lead sponsorSherif S. Farag
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment15
Start date2 November 2012
Primary completion27 August 2016
Estimated completion15 December 2017
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Sherif S. Farag

Who can join

Adults 18 to 60, any sex, with Acute Myeloid Leukemia or Acute Lymphoid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Percent of Subjects Engrafting by Day +30 After Transplantation Primary · Day 0 to Day +30 post transplant

Percent of patients and the 95% Binomial Confidence interval who were able to achieve neutrophils engraftment (defined as the date of the first of three consecutive ANC values obtained on different days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l) by 30 days following transplant.

GroupValue95% CI
Sitagliptin10078 – 100
Time to Neutrophil Engraftment Secondary · Transplant (Day 0) up to 1 year

Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients surviving at least 14 days after transplant will be evaluable for this endpoint. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.

GroupValue95% CI
Sitagliptin1913 – 20
Time to Platelet Engraftment Secondary · Transplant (Day 0) up to 1 year

Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of three consecutive Complete Blood Counts (CBCs) obtained on different days after transplantation during which the platelet count is at least 20 x109/l. The CBCs obtained should be at least seven days after the most recent platelet transfusion. Only patients who achieved engraftment of platelets will be included in the analysis. The median and 95% confidence intervals will be provided.

GroupValue95% CI
Sitagliptin5221 – 89
Number of Subjects With Treatment Related Adverse Events Grade 3 and 4 Non-hematological Toxicities Secondary · Day 0 up to 3 years

Number of unique patients who had a treatment related (possible, probable or definite) non-hematological adverse event that was graded 3 or greater.

GroupValue95% CI
Sitagliptin0

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 3 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Sitagliptin
Serious: 9/15 (60%)
Deaths:

Serious adverse events (20 terms)

ReactionSystemSitagliptin
Infections and infestations - OtherInfections and infestations
Multi-organ failureGeneral disorders
SepsisInfections and infestations
Respiratory failureRespiratory, thoracic and mediastinal disorders
Cardiac arrestCardiac disorders
ColitisGastrointestinal disorders
Oral painGastrointestinal disorders
Hepatitis viralInfections and infestations
MeningitisInfections and infestations
AcidosisMetabolism and nutrition disorders
AnorexiaMetabolism and nutrition disorders
DehydrationMetabolism and nutrition disorders
HydrocephalusNervous system disorders
Acute kidney injuryRenal and urinary disorders
Adult respiratory distress syndromeRespiratory, thoracic and mediastinal disorders
HypoxiaRespiratory, thoracic and mediastinal disorders
Pharyngeal mucositisRespiratory, thoracic and mediastinal disorders
Pulmonary edemaRespiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - OtherRespiratory, thoracic and mediastinal disorders
Capillary leak syndromeVascular disorders
Other adverse events (70 terms — click to expand)

ReactionSystemSitagliptin
Infections and infestations - OtherInfections and infestations
Mucositis oralGastrointestinal disorders
Blood bilirubin increasedInvestigations
AnorexiaMetabolism and nutrition disorders
HypoxiaRespiratory, thoracic and mediastinal disorders
HypotensionVascular disorders
FeverGeneral disorders
Urinary tract infectionInfections and infestations
Aspartate aminotransferase increasedInvestigations
EncephalopathyNervous system disorders
Acute kidney injuryRenal and urinary disorders
AnemiaBlood and lymphatic system disorders
Sinus bradycardiaCardiac disorders
DiarrheaGastrointestinal disorders
Localized edemaGeneral disorders
Hepatobiliary disorders - OtherHepatobiliary disorders
Lung infectionInfections and infestations
SepsisInfections and infestations
Upper respiratory infectionInfections and infestations
Alkaline phosphatase increasedInvestigations
Creatinine increasedInvestigations
Neutrophil count decreasedInvestigations
Platelet count decreasedInvestigations
HyperglycemiaMetabolism and nutrition disorders
HypokalemiaMetabolism and nutrition disorders
HematuriaRenal and urinary disorders
DyspneaRespiratory, thoracic and mediastinal disorders
Pulmonary edemaRespiratory, thoracic and mediastinal disorders
Disseminated intravascular coagulationBlood and lymphatic system disorders
Febrile neutropeniaBlood and lymphatic system disorders
Atrial fibrillationCardiac disorders
Cardiac disorders - OtherCardiac disorders
Heart failureCardiac disorders
Pericardial effusionCardiac disorders
Sinus tachycardiaCardiac disorders
Ventricular arrhythmiaCardiac disorders
Abdominal painGastrointestinal disorders
EnterocolitisGastrointestinal disorders
Gastrointestinal disorders - OtherGastrointestinal disorders
Lower gastrointestinal hemorrhageGastrointestinal disorders

Most-reported serious reactions: Infections and infestations - Other, Multi-organ failure, Sepsis, Respiratory failure, Cardiac arrest, Colitis, Oral pain, Hepatitis viral.

Data from ClinicalTrials.gov NCT01720264 adverse events section.

Sponsor's own description

The main purpose of this trial is to assess the efficacy and safety of sitagliptin in enhancing engraftment following umbilical cord blood transplantation (recovery of blood counts after transplant).

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Advances in umbilical cord blood manipulation-from niche to bedside.
    Lund TC, Boitano AE, Delaney CS, Shpall EJ, et al · · 2015 · cited 60× · PMID 25511187 · DOI 10.1038/nrclinonc.2014.215
  2. Umbilical Cord Blood Transplantation: Challenges and Future Directions.
    Ballen K. · · 2017 · cited 33× · PMID 28456009 · DOI 10.1002/sctm.17-0069
  3. Therapeutic Antibodies for Myeloid Neoplasms-Current Developments and Future Directions.
    Schürch CM. · · 2018 · cited 30× · PMID 29868474 · DOI 10.3389/fonc.2018.00152
  4. Validating Cell Surface Proteases as Drug Targets for Cancer Therapy: What Do We Know, and Where Do We Go?
    Verhulst E, Garnier D, De Meester I, Bauvois B. · · 2022 · cited 19× · PMID 35158891 · DOI 10.3390/cancers14030624
  5. The Bone Marrow Immune Microenvironment in CML: Treatment Responses, Treatment-Free Remission, and Therapeutic Vulnerabilities.
    Patterson SD, Copland M. · · 2023 · cited 16× · PMID 36780103 · DOI 10.1007/s11899-023-00688-6
  6. Clinical Progress and Preclinical Insights Into Umbilical Cord Blood Transplantation Improvement.
    Sun Z, Yao B, Xie H, Su X. · · 2022 · cited 9× · PMID 35972332 · DOI 10.1093/stcltm/szac056
  7. Novel targeted therapies in chronic myeloid leukemia.
    Ashaq MS, Zhou Q, Li Z, Zhao B. · · 2024 · cited 2× · PMID 41550150 · DOI 10.1016/j.pscia.2024.100052

Verify or expand the search:

Other trials of Sitagliptin

Trials testing the same drug.

Other recruiting trials for Acute Myeloid Leukemia

Currently open trials in the same condition.

Other Sherif S. Farag trials

Trials by the same sponsor.

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01720264.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing