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AzTrials

Acute Myeloid LeukemiaPhase 2NCT02190695

Leukemia SPORE Phase II DAC Study for R/R and Elderly Acute AML and MDS

A Phase 2 study testing Decitabine, Carboplatin and Arsenic trioxide in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Fox Chase Cancer Center at 2 sites in United States.

Completed

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

Official record
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Trial summary

The purpose of this study is to find a new way to treat Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML). All the drugs are used to treat AML and MDS but are not usually combined together. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Decitabine, Carboplatin and Arsenic trioxide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
2 sitesUnited States
Study dates
1 Apr 2013to 16 Apr 2020
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Patients with AML, relapsed or refractory to standard therapy or elderly patients with AML (age 65 or over). Patients who have AML and are younger than age 65 but considered unfit for conventional chemotherapy are eligible. Patients with de novo or treated MDS or CMML INT-1 or above are eligible. Patients may have had prior exposure to azacitidine but no more than one cycle of decitabine. Patients must have been off chemotherapy for 2 weeks prior to entering this study and have recovered from the toxicities of that therapy; A caveat to this is in the case of rapidly progressive disease. Hydroxyurea is permitted for control of elevated WBC prior to treatment and can be continued for the first 4 weeks of therapy. Erythropoiesis stimulating agents (ESAs) and GCSF are allowed before therapy. ESAs, GCSF or other growth factors are permitted on therapy.
  • Performance 0-2 (ECOG).
  • Adequate cardiac functions assessed by 2D ECHO (NYHA cardiac III-IV excluded).
  • Pre-treatment EKG
  • Adequate end organ function with creatinine </= 2mg/dL and total bilirubin </= 2mg/dL, AST and ALT </= or = 2.5 X institutional ULN.
  • Absence of significant intercurrent illness such as uncontrolled heart failure, unstable angina, cardiac arrhythmia and psychiatric illness which precludes the giving of informed consent.
  • Signed informed consent

Who cannot join

  • Nursing and pregnant females. Patients of childbearing potential should practice effective methods of contraception. Should a woman become preg-nant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Current uncontrolled infections.
  • Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Chronic kidney disease > stage 3.
  • HIV infection.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • M.D. Anderson Cancer Center

    Houston, Texas, 77030

  • Temple BMT Program at Jeanes Hospital

    Philadelphia, Pennsylvania, 19111

Other trials in United States

About this study

Official title: Leukemia SPORE Phase II Randomized Study of Decitabine Versus Decitabine and Carboplatin Versus Decitabine and Arsenic in Relapsed, Refractory, and Elderly Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

The purpose of this study is to find a new way to treat Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML). All the drugs are used to treat AML and MDS but are not usually combined together. The investigators are looking at both the safety and Efficacy of each combination.

Read the detailed description

Study Groups:

If the participant is found to be eligible to take part in this study and he/she is one of the first 30 participants enrolled, the participant will have an equal chance of being in one of 3 study groups. If the participant enrolls after the first 30 participants are enrolled, he/she will have a higher chance of being assigned to the group is having better results.

  • If participant is in Group 1, he/she will receive decitabine alone.
  • If participant is in Group 2, he/she will receive decitabine and carboplatin.
  • If participant is in Group 3, he/she will receive decitabine and arsenic trioxide.

Study Drug Administration:

Every 4 weeks is a study cycle.

The participant will receive decitabine by vein over about 1 hours on Days 1-5 of each cycle.

If the participant is receiving carboplatin, he/she will receive it over 1 hour on Day 8 (+/-2 days) of each cycle.

If the participant is receiving arsenic trioxide, he/she will receive it over about 1 hour on Days 1-5 of each cycle

Study Visits:

Blood (about 1-2 teaspoons) will be drawn 1-2 times a week during Cycle 1 and then every 2-4 weeks after that for routine tests. If you have stable disease, blood will only be drawn every 4-6 weeks.

On Day 28 of Cycle 3 (+/- 3 days), the participant will have a bone marrow aspirate and biopsy to check the status of the disease. After that, the participant will have bone marrow biopsies/aspirations when the doctor thinks it is needed.

If the participant is in Group 3, he/she will have EKGs on Day 1 of each cycle before receiving the study drugs. On Days 1 and 4 of each cycle, blood (about 1-2 teaspoons) will also be drawn for routine tests before their dose of the study drugs.

If the participant is taken off study, blood (about 1-2 teaspoons) will be drawn for routine tests.

Length of Study:

The participant may continue taking the study drugs for as long as the doctor thinks it is in your best interest. The participant will no longer be able to take the study drug(s) if the disease gets worse, if intolerable side effects occur, or if he/she is unable to follow study directions.

This is an investigational study. Arsenic trioxide is FDA approved and commercially available for the treatment of APL. Decitabine is FDA approved and commercially available for the treatment of MDS. Carboplatin is FDA approved and commercially available for the treatment solid tumors. The study drug or study drug combination the participant receives on this study are considered investigational.

Being tested
Decitabine, Carboplatin, Arsenic trioxide
Medical subject headings
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic

What participants receive

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

  • DecitabineDrug

    Also called Dacogen

    20 mg/m2 by vein daily over 1 hour on Days 1-5 of each 28 day cycle.

  • CarboplatinDrug

    Also called cis-Diammine, Paraplatin, Paraplatin-AQ

    AUC 5 by vein over 1 hour on Day 8 of each 28 day cycle.

  • Arsenic trioxideDrug

    Also called ATO

    0.15 mg/kg by vein over 1 hour on Days 1-5 of each 28 day cycle.

Study groups in NCT02190695
Study groupRoleWhat they receive
DecitabineActive comparatorDecitabine 20mg/m2 IV over 1hour daily times 5 days every 28 days
Receives: Drug: Decitabine
Decitabine and CarboplatinExperimentalDecitabine 20mg/m2 IV over 1hour daily times 5 days, plus Carboplatin AUC 5 IV over 1hour on day 8. repeat every 28 days.
Receives: Drug: Decitabine; Drug: Carboplatin
Decitabine and ArsenicExperimentalDecitabine 20mg/m2 IV over 1 hour daily for 5 days plus Arsenic Trioxide 0.15mg/kg IV daily for 5 days. repeat every 28 days
Receives: Drug: Decitabine; Drug: Arsenic trioxide

What is being measured

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

  1. Time to complete or partial remission

    evaluation of the complete and partial response rates (antileukemic effect) and the amount of time taken to achieve the response.

    Measured: up to 16 weeks

Timeline

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

  1. First posted15 Jul 2014 (estimated)
  2. Study start1 Apr 2013
  3. Primary completion26 Jun 2018
  4. Study completion16 Apr 2020

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02190695
Sponsor's protocol ID
21357
Status last verified
May 2021
First submitted
11 Jul 2014
Last updated
19 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated device
No

Publications

  • Kropf PL, Chung W, Shameem R, Xiao L, Balch C, Huang X, Issa JJ. A phase 2 study of decitabine with or without carboplatin and arsenic trioxide in patients with MDS and AML. Blood Neoplasia. 2025 Jan 23;2(2):100071. doi: 10.1016/j.bneo.2025.100071. eCollection 2025 May.

    PubMed 40453133

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Decitabine, Carboplatin and Arsenic trioxide in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Fox Chase Cancer Center at 2 sites 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 7 inclusion and 5 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 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Time to complete or partial remission (time frame: up to 16 weeks). 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 NCT02190695, which also lists 1 linked publication.

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 19 May 2021.

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