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Anti-metabolites

Pharmacological Study for Acute Myelogenous Leukemia

Phase 1 & 2
Waitlist Available
Led By Vinod Pullarkat
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must meet one of the three treatment history criteria: Relapsed AML who have failed at least 1 line of salvage therapy, De novo AML who have not achieved CR after 2 lines of therapy, AML evolving from myelodysplastic syndrome (MDS) or myeloproliferative disorder who have failed hypomethylating agent or induction chemotherapy, Patients who have relapsed after allogeneic hematopoietic cell transplant (HCT) are eligible if they are at least 3 months after HCT, do not have active graft vs. host disease (GVHD) and are off immunosuppression except for maintenance dose of steroids (prednisone 10 mg/day or less)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years following first study agent administration.
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is effective and has manageable side effects.

Eligible Conditions
  • Refractory Acute Myelogenous Leukemia
  • Acute Myeloid Leukemia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a certain type of blood cancer called AML and have either relapsed after previous treatment, not responded to previous treatment, or have a more advanced stage of the disease. If you have had a bone marrow transplant, you can participate as long as certain conditions are met.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years following first study agent administration.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years following first study agent administration. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicity (DLT)
Recommended Phase II Dose (RP2D) of 8-Chloro-adenosine (8-Cl-Ado)
Secondary outcome measures
Complete Remission Rate (CR + CRi)
Other outcome measures
Adenosine Triphosphatases
Level of protein expression and protein modifications
Adenine
+1 more

Side effects data

From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358
65%
Infusion related reaction
59%
Neutrophil count decreased
41%
Upper respiratory infection
29%
Aspartate aminotransferase increased
29%
Platelet count decreased
24%
Alanine aminotransferase increased
18%
Sinusitis
18%
Urinary tract infection
12%
Tooth infection
6%
Bronchial infection
6%
Acute Coronary Syndrome
6%
Febrile neutropenia
6%
Sepsis
6%
Infections and infestations - Other, specify
6%
Nail infection
6%
Rhinitis infective
6%
Tumor lysis syndrome
6%
Infusion Related Reaction
6%
Wound infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2 and MTD (800 mg Entospletinib Daily)
Phase 1, Dose 1 (400 mg Entospletinib Daily)

Trial Design

6Treatment groups
Experimental Treatment
Group I: Phase I - 800mg/m^2 1-hour infusionExperimental Treatment3 Interventions
800mg/m^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
Group II: Phase I - 600mg/m^2 4-hour infusionExperimental Treatment3 Interventions
600mg/m^2 8-chloro-adenosine administered a four-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
Group III: Phase I - 400mg/m^2 4-hour infusionExperimental Treatment3 Interventions
400mg/m^2 8-chloro-adenosine administered a four-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
Group IV: Phase I - 400mg/m^2 1-hour infusionExperimental Treatment3 Interventions
400mg/m^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
Group V: Phase I - 200mg/m^2 1-hour infusionExperimental Treatment3 Interventions
200mg/m^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
Group VI: Phase I - 100mg/m^2 1-hour infusionExperimental Treatment3 Interventions
100mg/m^2 8-chloro-adenosine administered a one-hour intravenous infusion daily for first 5 days of each 28-day cycle, up to four cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
8-Chloroadenosine
2015
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
560 Previous Clinical Trials
1,918,132 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,621 Previous Clinical Trials
40,927,402 Total Patients Enrolled
Vinod PullarkatPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
30 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other pharmacological research has recently been conducted?

"Presently, there are 9 clinical trials being conducted to assess the efficacy of Pharmacological Study. One trial is in its advanced Phase 3 stage and these experiments mostly take place at labs located within New york City, with a total of 14 research facilities involved."

Answered by AI

What objectives are commonly sought through Pharmacological Study?

"The use of Pharmacological Study is a common approach when treating myocardial scintigraphy. Additionally, this type of study can be utilized to manage varying heart ailments such as atrioventricular block, coronary artery disease (CAD), and myocardial perfusion imaging."

Answered by AI

Is there currently availability for potential participants in this trial?

"According to clinicaltrials.gov, this trial is closed and no longer enrolling patients; the initial post date was September 2nd 2015 with a last update on February 16th 2022. However, there are many other trials actively recruiting now at 1,613 sites across the world."

Answered by AI

What overarching aims have been determined for this experiment?

"This clinical trial aims to assess the Complete remission rate (CR + CRi) within 30 days after the completion of treatment. Secondary outcomes such as Duration of response, Overall survival, and Event-free survival will be subjected to Kaplan–Meier estimation."

Answered by AI

How many participants are being included in this medical experiment?

"This research has concluded its recruitment period, which began on September 2nd 2015 and finished February 16th 2022. If you are seeking other trials, there are currently 1604 studies pertaining to acute myeloid leukemia that require participants as well as 9 experiments concerning pharmacology in need of volunteers."

Answered by AI
~2 spots leftby Mar 2025