Acute Myeloid Leukemia Arising From Previous Myelodysplastic SyndromePhase 1/2NCT02509546

8-Chloroadenosine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

A Phase 1/2 study testing 8-Chloroadenosine, Laboratory Biomarker Analysis and Pharmacological Study in people with Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome and Recurrent Acute Myeloid Leukemia, run by City of Hope Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
What is being tested?: 8-Chloroadenosine, Laboratory Biomarker Analysis and Pharmacological Study
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 2 Sep 2015to 16 Mar 2021
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All subjects must have the ability to understand and the willingness to sign a written informed consent
Patients must have a life expectancy of > 3 months
Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Patients must have a diagnosis of AML as per World Health Organization (WHO) Classification of Hematologic Neoplasms
Patients must meet one of the three treatment history criteria:
Relapsed AML who have failed at least 1 line of salvage therapy

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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)
At least 2 weeks from prior chemotherapy or radiation therapy to time of start of treatment, except for hydroxyurea or corticosteroid therapy which may be continued through cycle 1
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 X ULN
Corrected QT (QTc) =< 480 ms
Calculated creatinine clearance (CrCl) >= 50 mL/min per 24 hour urine collection or the Cockcroft-Gault formula
Negative serum or urine beta-human chorionic gonadotropin (beta-HCG) test (female of childbearing potential only), to be performed locally within the screening period
Agreement by females of childbearing potential and sexually active males to use an effective method of contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for three months following duration of study participation; the effects of study treatment on a developing fetus have the potential for teratogenic or abortifacient effects; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately

Who cannot join

Current or planned use of other investigational agents, or concurrent biological chemotherapy, or radiation therapy during the study treatment period
Expected to undergo HCT within 120 days of enrollment
Current or planned use of agents that prolong or suspected to prolong QTc
Diagnosis of acute promyelocytic leukemia
Active central nervous system leukemia
Active fungal infection or bacterial sepsis

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Active peptic ulcer disease
History of heart failure or cardiac arrhythmia
Other active malignancy except for localized skin cancer, bladder, prostate, breast or cervical carcinoma in situ
Pregnant women and women who are lactating; 8-chloro-adenosine is an agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 8-chloro-adenosine, breastfeeding should be discontinued if the mother is treated with 8-chloro-adenosine
Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Trial locations and contacts

1 site in 1 country.

United States1 site

City of Hope Medical Center
Duarte, California, 91010

Other trials in United States

About this study

Official title: A Phase I/II Trial of 8-Chloro-Adenosine in Relapsed or Refractory Acute Myeloid Leukemia

This phase I/II trial studies the side effects and best dose of 8-chloroadenosine and to see how well it works in treating patients with acute myeloid leukemia that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Drugs used in chemotherapy, such as 8-chloroadenosine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Read the detailed description

PRIMARY OBJECTIVES:

To determine the maximum tolerated dose (recommended phase II dose, RP2D) of 8-chloro-adenosine, when given as a single agent, in patients with relapsed or refractory acute myeloid leukemia. (Phase I) II. To assess tolerability and safety of 8-chloro-adenosine at each dose level by evaluation of toxicities including: type, frequency, severity, attribution, time course and duration. (Phase I) III. To estimate the response rate and to evaluate the antitumor activity of 8-chloro-adenosine, when given as a single agent, as assessed by complete remission rate (complete remission [CR] + complete remission with incomplete blood count recovery [CRi]). (Phase II)

SECONDARY OBJECTIVES:

To evaluate for disease response to 8-chloro-adenosine in refractory/relapsed acute myeloid leukemia (AML) on each dose level tested. (Phase I) II. To obtain estimates of remission duration and survival probabilities (overall and event-free). (Phase II) III. To obtain an estimate of the overall response rate (CR + CRi + partial response [PR]). (Phase II) IV. To summarize and evaluate toxicities by type, frequency, severity, attribution, time course and duration. (Phase II)

CLINICAL PHARMACOLOGY OBJECTIVES:

To describe the plasma, urinary and cellular pharmacokinetics of 8-chloro-adenosine and metabolites.

II. To determine the impact of 8-chloro-adenosine on cellular adenosine triphosphate (ATP) pool in AML blasts.

III. To assess the impact of 8-chloro-adenosine therapy on select short-lived messenger (m) ribonucleic acids (RNAs) and corresponding proteins in circulating AML blasts.

IV. To correlate clinical responses and toxicity with plasma/urine 8-chloro-adenosine level (pharmacokinetic [PK]), cellular 8-chloro-ATP (PK) and cellular ATP pool.

EXPLORATORY EX-VIVO MOLECULAR OBJECTIVES:

To determine the cytotoxicity of 8-chloro-adenosine toward leukemic progenitor cells in vitro.

II. To generate a preliminary pre-treatment RNA/micro RNA (miRNA) signature in leukemic progenitor cells, and explore its possible association with in vitro cytotoxicity to 8-chloro-adenosine.

III. To explore the possible association between the preliminary RNA/miRNA signature and clinical response to 8-chloro-adenosine.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

Patients receive 8-chloro-adenosine intravenously (IV) over 4 hours on days 1-5. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 3 months for up to 2 years.

Conditions: Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Being tested: 8-Chloroadenosine, Laboratory Biomarker Analysis, Pharmacological Study
Medical subject headings: Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

8-ChloroadenosineDrug
Also called 8-Chloro-adenosine, 8-Cl-adenosine, 8-Cl-Ado
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
Pharmacological StudyOther
Correlative studies

Study groups in NCT02509546
Study group	Role	What they receive
Phase I - 100mg/m^2 1-hour infusion	Experimental	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. Receives: Drug: 8-Chloroadenosine; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study
Phase I - 200mg/m^2 1-hour infusion	Experimental	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. Receives: Drug: 8-Chloroadenosine; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study
Phase I - 400mg/m^2 1-hour infusion	Experimental	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. Receives: Drug: 8-Chloroadenosine; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study
Phase I - 800mg/m^2 1-hour infusion	Experimental	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. Receives: Drug: 8-Chloroadenosine; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study
Phase I - 400mg/m^2 4-hour infusion	Experimental	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. Receives: Drug: 8-Chloroadenosine; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study
Phase I - 600mg/m^2 4-hour infusion	Experimental	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. Receives: Drug: 8-Chloroadenosine; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study

What is being measured

The primary outcome is the main question the study is designed to answer.

Recommended Phase II Dose (RP2D) of 8-Chloro-adenosine (8-Cl-Ado)
According to the standard 3+3 rules, where the highest DL that produced ≤ 1/6 DLTs in cycle 1 would be defined as the maximum tolerated dose (MTD). The RP2D of 8-Cl-Ado would generally be the MTD, but it could be less than the initially calculated MTD as determined from a review of the available data and cumulative toxicities from phase 1.
Measured: Up to 28 days following first study agent administration.
Dose Limiting Toxicity (DLT)
Toxicity was graded according to the NCI-Common Terminology Criteria for Adverse Events version 4.03. A DLT was defined as any of the following toxicities (please see the details in section of 13.2 of the protocol) that occur during cycle 1, per CTCAE version 4.03, and were considered related to the study drug.
Measured: Up to 28 days following first study agent administration.

Secondary outcomes (1)

Complete Remission Rate (CR + CRi)
Complete remission rate (CR + CRi) based on the Döhner 2010 criteria and calculated as the percent of evaluable patients that have confirmed CR or CRi is to evaluate the antitumor activity of 8-chloro-adenosine.
Measured: Up to 2 years following first study agent administration.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Sep 201516 Mar 2021

First posted28 Jul 2015 (estimated)
Study start2 Sep 2015
Primary completion9 Mar 2021
Study completion16 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Myeloid Leukemia Arising From Previous Myelodysplastic SyndromeStudies of the same condition, open and under way.
More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
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 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02509546
Sponsor's protocol ID: 14269
Other IDs: NCI-2015-00871, 123456, 122489, 14269
Status last verified: Nov 2023
First submitted: 10 Jun 2015
Last updated: 5 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Trial of 8-Chloro-Adenosine in Relapsed or Refractory Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT02509546
Acronym / sponsor ID: 14269
Conditions: Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: City of Hope Medical CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 2 Sep 2015 (actual)
Primary completion: 9 Mar 2021 (actual)
Study completion: 16 Mar 2021 (actual)
First posted: 28 Jul 2015 (estimated)
Results: Posted 5 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To determine the maximum tolerated dose (recommended phase II dose, RP2D) of 8-chloro-adenosine, when given as a single agent, in patients with relapsed or refractory acute myeloid leukemia. (Phase I) II. To assess tolerability and safety of 8-chloro-adenosine at each dose level by evaluation of toxicities including: type, frequency, severity, attribution, time course and duration. (Phase I) III. To estimate the response rate and to evaluate the antitumor activity of 8-chloro-adenosine, when given as a single agent, as assessed by complete remission rate (complete remission [CR] + complete remission with incomplete blood count recovery [CRi]). (Phase II)

SECONDARY OBJECTIVES:

To evaluate for disease response to 8-chloro-adenosine in refractory/relapsed acute myeloid leukemia (AML) on each dose level tested. (Phase I) II. To obtain estimates of remission duration and survival probabilities (overall and event-free). (Phase II) III. To obtain an estimate of the overall response rate (CR + CRi + partial response [PR]). (Phase II) IV. To summarize and evaluate toxicities by type, frequency, severity, attribution, time course and duration. (Phase II)

CLINICAL PHARMACOLOGY OBJECTIVES:

To describe the plasma, urinary and cellular pharmacokinetics of 8-chloro-adenosine and metabolites.

II. To determine the impact of 8-chloro-adenosine on cellular adenosine triphosphate (ATP) pool in AML blasts.

III. To assess the impact of 8-chloro-adenosine therapy on select short-lived messenger (m) ribonucleic acids (RNAs) and corresponding proteins in circulating AML blasts.

IV. To correlate clinical responses and toxicity with plasma/urine 8-chloro-adenosine level (pharmacokinetic [PK]), cellular 8-chloro-ATP (PK) and cellular ATP pool.

EXPLORATORY EX-VIVO MOLECULAR OBJECTIVES:

To determine the cytotoxicity of 8-chloro-adenosine toward leukemic progenitor cells in vitro.

II. To generate a preliminary pre-treatment RNA/micro RNA (miRNA) signature in leukemic progenitor cells, and explore its possible association with in vitro cytotoxicity to 8-chloro-adenosine.

III. To explore the possible association between the preliminary RNA/miRNA signature and clinical response to 8-chloro-adenosine.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

Patients receive 8-chloro-adenosine intravenously (IV) over 4 hours on days 1-5. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 3 months for up to 2 years.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Phase I - 100mg/m^2 1-hour infusion	Experimental	Drug: 8-Chloroadenosine, Other: Laboratory Biomarker Analysis, Other: Pharmacological Study100mg/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.
Phase I - 200mg/m^2 1-hour infusion	Experimental	Drug: 8-Chloroadenosine, Other: Laboratory Biomarker Analysis, Other: Pharmacological Study200mg/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.
Phase I - 400mg/m^2 1-hour infusion	Experimental	Drug: 8-Chloroadenosine, Other: Laboratory Biomarker Analysis, Other: Pharmacological Study400mg/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.
Phase I - 800mg/m^2 1-hour infusion	Experimental	Drug: 8-Chloroadenosine, Other: Laboratory Biomarker Analysis, Other: Pharmacological Study800mg/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.
Phase I - 400mg/m^2 4-hour infusion	Experimental	Drug: 8-Chloroadenosine, Other: Laboratory Biomarker Analysis, Other: Pharmacological Study400mg/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.
Phase I - 600mg/m^2 4-hour infusion	Experimental	Drug: 8-Chloroadenosine, Other: Laboratory Biomarker Analysis, Other: Pharmacological Study600mg/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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

All subjects must have the ability to understand and the willingness to sign a written informed consent
Patients must have a life expectancy of > 3 months
Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Patients must have a diagnosis of AML as per World Health Organization (WHO) Classification of Hematologic Neoplasms
Patients must meet one of the three treatment history criteria:

Key exclusion criteria (12 listed)

Current or planned use of other investigational agents, or concurrent biological chemotherapy, or radiation therapy during the study treatment period
Expected to undergo HCT within 120 days of enrollment
Current or planned use of agents that prolong or suspected to prolong QTc
Diagnosis of acute promyelocytic leukemia
Active central nervous system leukemia

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
8-ChloroadenosineAlso: 8-Chloro-adenosine, 8-Cl-adenosine, 8-Cl-AdoGiven IV	Drug	Phase I - 100mg/m^2 1-hour infusion, Phase I - 200mg/m^2 1-hour infusion, Phase I - 400mg/m^2 1-hour infusion, Phase I - 400mg/m^2 4-hour infusion, Phase I - 600mg/m^2 4-hour infusion, Phase I - 800mg/m^2 1-hour infusion
Laboratory Biomarker AnalysisCorrelative studies	Other	Phase I - 100mg/m^2 1-hour infusion, Phase I - 200mg/m^2 1-hour infusion, Phase I - 400mg/m^2 1-hour infusion, Phase I - 400mg/m^2 4-hour infusion, Phase I - 600mg/m^2 4-hour infusion, Phase I - 800mg/m^2 1-hour infusion
Pharmacological StudyCorrelative studies	Other	Phase I - 100mg/m^2 1-hour infusion, Phase I - 200mg/m^2 1-hour infusion, Phase I - 400mg/m^2 1-hour infusion, Phase I - 400mg/m^2 4-hour infusion, Phase I - 600mg/m^2 4-hour infusion, Phase I - 800mg/m^2 1-hour infusion

Primary outcome

Recommended Phase II Dose (RP2D) of 8-Chloro-adenosine (8-Cl-Ado)
Time frame: Up to 28 days following first study agent administration.
According to the standard 3+3 rules, where the highest DL that produced ≤ 1/6 DLTs in cycle 1 would be defined as the maximum tolerated dose (MTD). The RP2D of 8-Cl-Ado would generally be the MTD, but it could be less than the initially calculated MTD as determined from a review of the available data and cumulative toxicities from phase 1.
Dose Limiting Toxicity (DLT)
Time frame: Up to 28 days following first study agent administration.
Toxicity was graded according to the NCI-Common Terminology Criteria for Adverse Events version 4.03. A DLT was defined as any of the following toxicities (please see the details in section of 13.2 of the protocol) that occur during cycle 1, per CTCAE version 4.03, and were considered related to the study drug.

1 secondary outcome

Complete Remission Rate (CR + CRi)
Time frame: Up to 2 years following first study agent administration.

Results and safety

Results posted to the registry on 5 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase I - 100mg/m^2 1-hour Infusion	3	3
Phase I - 200mg/m^2 1-hour Infusion	3	3
Phase I - 400mg/m^2 1-hour Infusion	4	4
Phase I - 800mg/m^2 1-hour Infusion	2	2
Phase I - 400mg/m^2 4-hour Infusion	2	2
Phase I - 600mg/m^2 4-hour Infusion	6	6

Primary outcome: Recommended Phase II Dose (RP2D) of 8-Chloro-adenosine (8-Cl-Ado)

Time frame: Up to 28 days following first study agent administration.. Number. Unit: mg/m^2

Measure	Phase I - Treatment (8-chloro-adenosine) n = 20
Value	400

Population analysed: 3 patients at 100 mg/m\^2 1-hr; 3 patients at 200 mg/m\^2 1-hr; 4 patients at 400 mg/m\^2 1-hr; 2 patients at 800 mg/m\^2 1-hr; 2 patients at 400 mg/m\^2 4-hr; 6 patients at 600 mg/m\^2 4-hr.

Primary outcome: Dose Limiting Toxicity (DLT)

Time frame: Up to 28 days following first study agent administration.. Count of participants. Unit: Participants

Measure	Phase I - 100mg/m^2 8-chloro-adenosine 1-hour Infusion n = 3	Phase I - 200mg/m^2 8-chloro-adenosine 1-hour Infusion n = 3	Phase I - 400mg/m^2 8-chloro-adenosine 1-hour Infusion n = 4	Phase I - 800mg/m^2 8-chloro-adenosine 1-hour Infusion n = 2	Phase I - 400mg/m^2 8-chloro-adenosine 4-hour Infusion n = 2	Phase I - 600mg/m^2 8-chloro-adenosine 4-hour Infusion n = 6
Value	0	0	1	2	0	2

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 2 years following first study agent administration.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase I - 100mg/m^2 8-chloro-adenosine 1-hour Infusion	1 of 3 (33.3%)	3 of 3 (100%)	3 of 3
Phase I - 200mg/m^2 8-chloro-adenosine 1-hour Infusion	1 of 3 (33.3%)	3 of 3 (100%)	3 of 3
Phase I - 400mg/m^2 8-chloro-adenosine 1-hour Infusion	2 of 4 (50%)	4 of 4 (100%)	4 of 4
Phase I - 800mg/m^2 8-chloro-adenosine 1-hour Infusion	2 of 2 (100%)	2 of 2 (100%)	2 of 2
Phase I - 400mg/m^2 8-chloro-adenosine 4-hour Infusion	2 of 2 (100%)	2 of 2 (100%)	2 of 2
Phase I - 600mg/m^2 8-chloro-adenosine 4-hour Infusion	6 of 6 (100%)	6 of 6 (100%)	6 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Vinod Pullarkat principal investigator

City of Hope Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 16 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: finished, as of the sponsor's last update on 5 Dec 2023. 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 United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended Phase II Dose (RP2D) of 8-Chloro-adenosine (8-Cl-Ado) (time frame: Up to 28 days following first study agent administration.). The study lists 2 primary outcomes in all. 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 NCT02509546.

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 5 Dec 2023.