Untreated Adult Acute Myeloid LeukemiaPhase 2NCT02096055

Guadecitabine With or Without Idarubicin or Cladribine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

A Phase 2 study testing Cladribine, Guadecitabine and Idarubicin in people with Untreated Adult Acute Myeloid Leukemia, run by M.D. Anderson Cancer 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 70 years and older
Conditions the study is for: Untreated Adult Acute Myeloid Leukemia
What is being tested?: Cladribine, Guadecitabine and Idarubicin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteUnited States
Study dates: 4 Apr 2014to 24 Nov 2020
Phase: Phase 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 70 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

Previously untreated AML patients, except those who have received prior therapy with hydroxyurea, single agent chemotherapy (e.g. decitabine), hematopoietic growth factors, biological or targeted therapies are allowed
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Sign a written informed consent form
Total bilirubin =< 2 mg/dL
Serum glutamate pyruvate transaminase (SGPT) or serum glutamic oxaloacetic transaminase (SGOT) =< 4 x upper limit of normal (ULN)
Creatinine clearance of >= 50 mL/min (estimated by the Cockcroft-Gault [C-G] formula)
Male patients must use an effective contraceptive method during the study and for a minimum of 8 weeks after study treatment
Baseline left ventricular ejection fraction (LVEF) >= 40%

Who cannot join

Patients with >= New York Heart Association (NYHA) grade 3 heart disease as assessed by history and/or physical examination
Patients who received more than one full course of prior hypomethylating agents azacitidine or decitabine
Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment
Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
Pregnant or lactating patients
Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
Any concurrent malignancy with the exception of the following: a) patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed; b) patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed

Trial locations and contacts

1 site in 1 country.

United States1 site

M D Anderson Cancer Center
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Four-Arm Randomized Phase II Study of SGI-110: 5 Days, Versus 10 Days, Versus 5 Days + Idarubicin, Versus 5 Days + Cladribine, in Previously Untreated Patients >/= 70 Years With Acute Myeloid Leukemia

This randomized phase II trial studies how well guadecitabine with or without idarubicin or cladribine works in treating older patients with previously untreated acute myeloid leukemia. Guadecitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as idarubicin and cladribine, 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. It is not yet known whether guadecitabine with or without idarubicin or cladribine is more effective in treating older patients with previously untreated acute myeloid leukemia.

Read the detailed description

PRIMARY OBJECTIVES:

To determine the complete remission (CR) rate, remission duration, leukemia-free survival, and survival in patients >= 70 years with previously untreated acute myeloid leukemia (AML) with 4 different guadecitabine (SGI-110) single agent and SGI-110 based combination regimens.

II. To determine the safety profile and tolerability of the 4 SGI-110 single agent and SGI-110 based combination regimens in patients >= 70 years of age with previously untreated AML.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I:

INDUCTION THERAPY: Patients receive guadecitabine subcutaneously (SC) on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CR with incomplete platelet recovery (CRp) continue on to Maintenance therapy; patients not achieving CR or complete remission with incomplete hematologic recovery (CRi) but deriving clinical benefit may continue to Maintenance therapy at the discretion of the Principal Investigator (PI).

MAINTENANCE THERAPY: Patients receive guadecitabine as in Induction therapy. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.

ARM II (CLOSED):

INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-10. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI.

MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 (days 1-10 of courses 1 and 2). Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.

ARM III:

INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin intravenously (IV) over up to 1 hour on days 1-2. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI.

MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on day 1. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.

ARM IV (CLOSED):

INDUCTION THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI.

MAINTENANCE THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every month.

Conditions: Untreated Adult Acute Myeloid Leukemia
Being tested: Cladribine, Guadecitabine, Idarubicin

What participants receive

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

CladribineDrug
Also called 2-CdA, 2CDA, CdA, Cladribina
Given IV
GuadecitabineDrug
Also called DNMT inhibitor SGI-110, S110, SGI-110
Given SC
IdarubicinDrug
Also called 4-Demethoxydaunomycin, 4-demethoxydaunorubicin, 4-DMDR
Given IV

Study groups in NCT02096055
Study group	Role	What they receive
Arm I (guadecitabine)	Experimental	INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine as in Induction therapy. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Receives: Drug: Guadecitabine
Arm II (CLOSED) (guadecitabine)	Experimental	INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-10. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 (days 1-10 of courses 1 and 2). Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Receives: Drug: Guadecitabine
Arm III (guadecitabine, idarubicin)	Experimental	INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on days 1-2. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on day 1. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Receives: Drug: Guadecitabine; Drug: Idarubicin
Arm IV (CLOSED) (guadecitabine, cladribine)	Experimental	INDUCTION THERPAY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Receives: Drug: Cladribine; Drug: Guadecitabine

What is being measured

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

Number of Participants With a Complete Response
Complete Response = Complete Remission (CR) + Complete Remission without blood count recovery (CRi) - CR: Neutrophil count >/= 1.0 x 10^9/L and platelet count >/= 100 x 10^9/L, and normal bone marrow differential (</+ 5% blasts). (CRi): Peripheral blood and bonemarrow results as for CR, but with platelet counts of < 100 x 109/L or ANC < 1.0 x 109/L
Measured: Up to 4 years, 3 months
Remission Duration
The date of Complete Response to the date of loss of response or last follow-up.
Measured: Up to 4 years, 3 months
Leukemia-free Survival
Survival time will be estimated using the Kaplan-Meier method. The two-sided log-rank test will be used to assess the differences of time to events between groups. Time from date of treatment start until the date of first objective documentation of disease-relapse.
Measured: Up to 4 years, 3 months
Survival
Survival time will be estimated using the Kaplan-Meier method. The two-sided log-rank test will be used to assess the differences of time to events between groups.
Measured: Up to 4 years, 3 months
Number of Participants With the Most Frequently Reports Grade 3 or 4 Adverse Event.
The most frequently reported adverse events will be determined by the Principal Investigator. The number of participants who experienced the most frequent grade 3 or 4 adverse events will be reported.
Measured: Up to 4 years, 3 months

Timeline

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

4 Apr 201424 Nov 2020

First posted26 Mar 2014 (estimated)
Study start4 Apr 2014
Primary completion24 Nov 2020
Study completion24 Nov 2020

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 Untreated Adult Acute Myeloid LeukemiaStudies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02096055
Sponsor's protocol ID: 2013-0843
Other IDs: NCI-2014-00981, 2013-0843
Status last verified: Aug 2024
First submitted: 20 Mar 2014
Last updated: 27 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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

RecruitingObservational study
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
Chronic Myeloproliferative Disorders, Leukemia
Active, not recruitingPhase 2
Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
Acute Myeloid Leukemia, Adult Acute Megakaryoblastic Leukemia
RecruitingPhase 1
Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML/HR-MDS and in Combination With Azacitidine in Previously Untreated HR-MDS
AML, Adult, MDS
RecruitingPhase 2
Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
Active, not recruitingPhase 2
Combination Chemotherapy and Ponatinib Hydrochloride in Treating Patients With Acute Lymphoblastic Leukemia
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia

All Untreated Adult Acute Myeloid Leukemia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Four-Arm Randomized Phase II Study of SGI-110: 5 Days, Versus 10 Days, Versus 5 Days + Idarubicin, Versus 5 Days + Cladribine, in Previously Untreated Patients >/= 70 Years With Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT02096055
Acronym / sponsor ID: 2013-0843
Conditions: Untreated Adult Acute Myeloid Leukemia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: M.D. Anderson Cancer CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 4 Apr 2014 (actual)
Primary completion: 24 Nov 2020 (actual)
Study completion: 24 Nov 2020 (actual)
First posted: 26 Mar 2014 (estimated)
Results: Posted 24 May 2022

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 complete remission (CR) rate, remission duration, leukemia-free survival, and survival in patients >= 70 years with previously untreated acute myeloid leukemia (AML) with 4 different guadecitabine (SGI-110) single agent and SGI-110 based combination regimens.

II. To determine the safety profile and tolerability of the 4 SGI-110 single agent and SGI-110 based combination regimens in patients >= 70 years of age with previously untreated AML.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I:

MAINTENANCE THERAPY: Patients receive guadecitabine as in Induction therapy. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.

ARM II (CLOSED):

ARM III:

ARM IV (CLOSED):

After completion of study treatment, patients are followed up every month.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Arm I (guadecitabine)	Experimental	Drug: GuadecitabineINDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine as in Induction therapy. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
Arm II (CLOSED) (guadecitabine)	Experimental	Drug: GuadecitabineINDUCTION THERAPY: Patients receive guadecitabine SC on days 1-10. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 (days 1-10 of courses 1 and 2). Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
Arm III (guadecitabine, idarubicin)	Experimental	Drug: Guadecitabine, Drug: IdarubicinINDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on days 1-2. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on day 1. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
Arm IV (CLOSED) (guadecitabine, cladribine)	Experimental	Drug: Cladribine, Drug: GuadecitabineINDUCTION THERPAY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.

Who may qualify

Ages: 70 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (8 listed)

Previously untreated AML patients, except those who have received prior therapy with hydroxyurea, single agent chemotherapy (e.g. decitabine), hematopoietic growth factors, biological or targeted therapies are allowed
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Sign a written informed consent form
Total bilirubin =< 2 mg/dL
Serum glutamate pyruvate transaminase (SGPT) or serum glutamic oxaloacetic transaminase (SGOT) =< 4 x upper limit of normal (ULN)

Key exclusion criteria (7 listed)

Patients with >= New York Heart Association (NYHA) grade 3 heart disease as assessed by history and/or physical examination
Patients who received more than one full course of prior hypomethylating agents azacitidine or decitabine
Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment
Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
Pregnant or lactating patients

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
CladribineAlso: 2-CdA, 2CDA, CdA, CladribinaGiven IV	Drug	Arm IV (CLOSED) (guadecitabine, cladribine)
GuadecitabineAlso: DNMT inhibitor SGI-110, S110, SGI-110Given SC	Drug	Arm I (guadecitabine), Arm II (CLOSED) (guadecitabine), Arm III (guadecitabine, idarubicin), Arm IV (CLOSED) (guadecitabine, cladribine)
IdarubicinAlso: 4-Demethoxydaunomycin, 4-demethoxydaunorubicin, 4-DMDRGiven IV	Drug	Arm III (guadecitabine, idarubicin)

Primary outcome

Number of Participants With a Complete Response
Time frame: Up to 4 years, 3 months
Complete Response = Complete Remission (CR) + Complete Remission without blood count recovery (CRi) - CR: Neutrophil count >/= 1.0 x 10^9/L and platelet count >/= 100 x 10^9/L, and normal bone marrow differential (</+ 5% blasts). (CRi): Peripheral blood and bonemarrow results as for CR, but with platelet counts of < 100 x 109/L or ANC < 1.0 x 109/L
Remission Duration
Time frame: Up to 4 years, 3 months
The date of Complete Response to the date of loss of response or last follow-up.
Leukemia-free Survival
Time frame: Up to 4 years, 3 months
Survival time will be estimated using the Kaplan-Meier method. The two-sided log-rank test will be used to assess the differences of time to events between groups. Time from date of treatment start until the date of first objective documentation of disease-relapse.
Survival
Time frame: Up to 4 years, 3 months
Survival time will be estimated using the Kaplan-Meier method. The two-sided log-rank test will be used to assess the differences of time to events between groups.
Number of Participants With the Most Frequently Reports Grade 3 or 4 Adverse Event.
Time frame: Up to 4 years, 3 months
The most frequently reported adverse events will be determined by the Principal Investigator. The number of participants who experienced the most frequent grade 3 or 4 adverse events will be reported.

Results and safety

Results posted to the registry on 24 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm I (Guadecitabine) x 5 Days	13	13
Arm II (CLOSED) (Guadecitabine) x 10 Days	9	9
Arm III (Guadecitabine, Idarubicin)	13	13
Arm IV (CLOSED) (Guadecitabine, Cladribine)	9	9

Primary outcome: Number of Participants With a Complete Response

Time frame: Up to 4 years, 3 months. Count of participants. Unit: Participants

Measure	Arm I (Guadecitabine) x 5 Days n = 13	Arm II (CLOSED) (Guadecitabine) x 10 Days n = 9	Arm III (Guadecitabine, Idarubicin) n = 13	Arm IV (CLOSED) (Guadecitabine, Cladribine) n = 9
Value	5	5	10	0

Primary outcome: Remission Duration

Time frame: Up to 4 years, 3 months. Median (Full Range). Unit: Months

Measure	Arm I (Guadecitabine) x 5 Days n = 5	Arm II (CLOSED) (Guadecitabine) x 10 Days n = 5	Arm III (Guadecitabine, Idarubicin) n = 10	Arm IV (CLOSED) (Guadecitabine, Cladribine) n = 0
Value	7.4 (1.2 to 12.6)	14.2 (5.7 to 19.0)	5.3 (1.4 to 37.0)	–

Population analysed: Zero participants in the guadecitabine + Cladribine arm had a Complete Response.

Primary outcome: Leukemia-free Survival

Time frame: Up to 4 years, 3 months. Median (Full Range). Unit: Months

Measure	Arm I (Guadecitabine) x 5 Days n = 13	Arm II (CLOSED) (Guadecitabine) x 10 Days n = 9	Arm III (Guadecitabine, Idarubicin) n = 13	Arm IV (CLOSED) (Guadecitabine, Cladribine) n = 9
Value	4.2 (2.1 to 13.9)	10.0 (0.5 to 21.7)	7.4 (2.0 to 39.5)	4.3 (1.1 to 28.9)

Primary outcome: Survival

Time frame: Up to 4 years, 3 months. Median (Full Range). Unit: Months

Measure	Arm I (Guadecitabine) x 5 Days n = 13	Arm II (CLOSED) (Guadecitabine) x 10 Days n = 9	Arm III (Guadecitabine, Idarubicin) n = 13	Arm IV (CLOSED) (Guadecitabine, Cladribine) n = 9
Value	13.1 (3.3 to 28.8)	13.0 (0.5 to 43.8)	15.4 (2.0 to 47.0)	11.9 (1.9 to 28.9)

Adverse events

Time frame: Up to 4 years, 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm I (Guadecitabine) x 5 Days	9 of 13 (69.2%)	13 of 13 (100%)	2 of 13
Arm II (CLOSED) (Guadecitabine) x 10 Days	7 of 9 (77.8%)	7 of 9 (77.8%)	1 of 9
Arm III (Guadecitabine, Idarubicin)	10 of 13 (76.9%)	13 of 13 (100%)	1 of 13
Arm IV (CLOSED) (Guadecitabine, Cladribine)	6 of 9 (66.7%)	9 of 9 (100%)	2 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.

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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.

Hagop M Kantarjian principal investigator

M.D. Anderson Cancer Center

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cladribine, Guadecitabine and Idarubicin in people with Untreated Adult Acute Myeloid Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.

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 8 inclusion and 7 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 27 Aug 2024. 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 phase mean?

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 24 May 2022). 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?

Number of Participants With a Complete Response (time frame: Up to 4 years, 3 months). The study lists 5 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 NCT02096055.

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 27 Aug 2024.