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8-Chloroadenosine + Venetoclax for Acute Myeloid Leukemia

Phase 1
Recruiting
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
- Failed at least 1 line of salvage therapy or untreated relapse and not candidates for allogeneic hematopoietic stem cell transplantation (alloHCT)
Age: >= 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial is testing a new combination therapy of 8-chloroadenosine and venetoclax to see if it is safe and effective in treating patients with acute myeloid leukemia.

Who is the study for?
Adults (18+) with relapsed or refractory Acute Myeloid Leukemia who have failed at least one line of therapy, are not eligible for stem cell transplant soon, and do not have active central nervous system leukemia or other serious conditions. Participants must be able to swallow capsules, not be pregnant or breastfeeding, and agree to use effective birth control.Check my eligibility
What is being tested?
This phase I trial is testing the safety and optimal dosage of a new drug combo: 8-Chloroadenosine with Venetoclax. The goal is to see if this combination can block cancer growth in patients whose AML has returned after treatment or hasn't responded at all.See study design
What are the potential side effects?
Potential side effects may include issues related to liver function (elevated enzymes), kidney function (creatinine clearance), blood disorders (low white blood cell count), gastrointestinal symptoms due to medication intake, and possible risks during pregnancy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have relapsed and am not eligible for a specific stem cell transplant.
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I am 18 years old or older.
Select...
I agree not to donate sperm during and for 90 days after treatment.
Select...
I had a stem cell transplant over 3 months ago, have no active GVHD, and am on low-dose steroids or none.
Select...
My AML has come back or didn't respond to treatment.
Select...
My cancer did not fully respond after 2 treatments and I can't have a stem cell transplant.
Select...
My kidneys are working well, as shown by a test.
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I can take care of myself and perform daily activities.
Select...
I am capable of having children and have not been surgically sterilized.
Select...
My AML came from MDS or a myeloproliferative disorder and treatments like HMA didn't work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year 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)
Incidence of adverse events (AEs)
Secondary outcome measures
Duration of response (DOR)
Event-free survival (EFS)
Overall survival (OS)
+1 more

Side effects data

From 2021 Phase 1 & 2 trial • 20 Patients • NCT02509546
100%
HYPONATREMIA
100%
HYPERTENSION
100%
WHITE BLOOD CELL DECREASED
100%
BLOOD BILIRUBIN INCREASED
100%
PLATELET COUNT DECREASED
100%
ANEMIA
100%
HYPOALBUMINEMIA
100%
HYPOCALCEMIA
67%
FEBRILE NEUTROPENIA
67%
ANOREXIA
67%
HYPOTENSION
67%
ALKALOSIS
67%
PLEURAL EFFUSION
67%
COUGH
67%
HYPOXIA
67%
HYPOPHOSPHATEMIA
67%
EDEMA LIMBS
67%
HYPOKALEMIA
67%
PROTEINURIA
67%
DIARRHEA
67%
CONSTIPATION
67%
DYSPNEA
67%
WEIGHT GAIN
67%
ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED
67%
LYMPHOCYTE COUNT DECREASED
67%
HYPOMAGNESEMIA
33%
HEMATURIA
33%
LETHARGY
33%
SOMNOLENCE
33%
HEMATOMAS
33%
MUCOSITIS ORAL
33%
FECAL INCONTINENCE
33%
DRY SKIN
33%
ACUTE MYELOGENOUS LEUKEMIA
33%
PULMONARY INFILTRATES
33%
RHINORRHEA
33%
MALAISE
33%
SORE THROAT
33%
ERYTHEMATOUS FOLLICULAR RASH
33%
CARDIOMEGALY
33%
WHEEZING
33%
ABDOMINAL DISCOMFORT
33%
URINARY TRACT INFECTION
33%
HYPOGLYCEMIA
33%
RIGHT SHOULDER PAIN
33%
TREMOR
33%
ANXIETY
33%
SCROTAL EDEMA
33%
CATHETER RELATED INFECTION
33%
PRODUCTIVE COUGH
33%
AGITATION
33%
SINUS TACHYCARDIA
33%
C. DIFFICILE COLITIS
33%
FATIGUE
33%
PERICARDIAL EFFUSION
33%
ALKALINE PHOSPHATASE INCREASED
33%
VOMITING
33%
MYALGIA
33%
HEADACHE
33%
PULMONARY HYPERTENSION
33%
NAUSEA
33%
CONFUSION
33%
PNEUMONIA
33%
CHEST PAIN CARDIAC
33%
EPISTAXIS
33%
LUNG INFILTRATES
33%
ASPARTATE AMINOTRANSFERASE INCREASED
33%
DYSPHAGIA
33%
FLUID OVERLOAD
33%
HICKMAN SITE DISCOMFORT
33%
CREATININE INCREASED
33%
NEUTROPHIL COUNT DECREASED
33%
HYPERKALEMIA
33%
HYPERGLYCEMIA
33%
REFRACTORY RELAPSED ACUTE MYELOID LEUKEMIA
33%
DIZZINESS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase I - 100mg/m^2 8-chloro-adenosine 1-hour Infusion
Phase I - 400mg/m^2 8-chloro-adenosine 4-hour Infusion
Phase I - 200mg/m^2 8-chloro-adenosine 1-hour Infusion
Phase I - 400mg/m^2 8-chloro-adenosine 1-hour Infusion
Phase I - 800mg/m^2 8-chloro-adenosine 1-hour Infusion
Phase I - 600mg/m^2 8-chloro-adenosine 4-hour Infusion

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (8-chloroadenosine, venetoclax)Experimental Treatment2 Interventions
Patients receive 8-Cl-Ado IV over 4 hours daily on days 1-5 and venetoclax PO QD on days 1-28. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
8-Chloroadenosine
2015
Completed Phase 2
~20
Venetoclax
2019
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
570 Previous Clinical Trials
1,922,586 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,703 Previous Clinical Trials
40,931,720 Total Patients Enrolled
Vinod PullarkatPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

8-Chloroadenosine (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05263284 — Phase 1
Acute Myelogenous Leukemia Research Study Groups: Treatment (8-chloroadenosine, venetoclax)
Acute Myelogenous Leukemia Clinical Trial 2023: 8-Chloroadenosine Highlights & Side Effects. Trial Name: NCT05263284 — Phase 1
8-Chloroadenosine (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05263284 — Phase 1

Frequently Asked Questions

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

To what extent is 8-Chloroadenosine a safe and reliable treatment for individuals?

"The data available for 8-Chloroadenosine's safety and efficacy is limited, thus it was rated a 1 on the Power team scale."

Answered by AI

How many participants have enrolled in the research project thus far?

"Affirmative. Clinicaltrials.gov attests that this research study, which was initially posted on July 25th 2022, is currently recruiting participants. Approximately 30 patients are being called for at a single medical centre."

Answered by AI

What are the primary goals of this research endeavor?

"This clinical trial will be evaluated over the course of a 28-day cycle. The primary outcome is to measure adverse effects, while secondary objectives include assessing time to response (defined by ELN criteria 2017) using Kaplan and Meier's product-limit method, determining duration of response according to ELN guidelines and employing Kaplan and Meier once again, as well as measuring overall survival with the same methodology."

Answered by AI

Are there any vacancies available in this study for participants?

"Affirmative. The information provided on clinicaltrials.gov suggests that this medical trial is actively enrolling participants and was initially posted on July 25th 2022, with its most recent update occurring on August 15th 2022. At present, the study requires 30 individuals to register from a single facility."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
8-Chloroadenosine in Combination With Venetoclax for the Treatment of Patients With Relapsed/Refractory Acute Myeloid Leukemia
2022. "8-Chloroadenosine in Combination With Venetoclax for the Treatment of Patients With Relapsed/Refractory Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05263284.
~20 spots leftby Jan 2027
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