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

May 18, 2021 updated by: Fox Chase Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Temple BMT Program at Jeanes Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • M.D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.
  2. Performance 0-2 (ECOG).
  3. Adequate cardiac functions assessed by 2D ECHO (NYHA cardiac III-IV excluded).
  4. Pre-treatment EKG
  5. Adequate end organ function with creatinine </= 2mg/dL and total bilirubin </= 2mg/dL, AST and ALT </= or = 2.5 X institutional ULN.
  6. Absence of significant intercurrent illness such as uncontrolled heart failure, unstable angina, cardiac arrhythmia and psychiatric illness which precludes the giving of informed consent.
  7. Signed informed consent

Exclusion Criteria:

  1. 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.
  2. Current uncontrolled infections.
  3. 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.
  4. Chronic kidney disease > stage 3.
  5. HIV infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Decitabine
Decitabine 20mg/m2 IV over 1hour daily times 5 days every 28 days
Drug: Decitabine
20 mg/m2 by vein daily over 1 hour on Days 1-5 of each 28 day cycle.
Other Names:
  • Dacogen
Experimental: Decitabine and Carboplatin
Decitabine 20mg/m2 IV over 1hour daily times 5 days, plus Carboplatin AUC 5 IV over 1hour on day 8. repeat every 28 days.
Drug: Decitabine
20 mg/m2 by vein daily over 1 hour on Days 1-5 of each 28 day cycle.
Other Names:
  • Dacogen
Drug: Carboplatin
AUC 5 by vein over 1 hour on Day 8 of each 28 day cycle.
Other Names:
  • Paraplatin
  • cis-Diammine
  • Paraplatin-AQ
Experimental: Decitabine and Arsenic
Decitabine 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
Drug: Decitabine
20 mg/m2 by vein daily over 1 hour on Days 1-5 of each 28 day cycle.
Other Names:
  • Dacogen
Drug: Arsenic trioxide
0.15 mg/kg by vein over 1 hour on Days 1-5 of each 28 day cycle.
Other Names:
  • ATO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to complete or partial remission
Time Frame: up to 16 weeks
evaluation of the complete and partial response rates (antileukemic effect) and the amount of time taken to achieve the response.
up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fox Chase Cancer Center

Collaborators

M.D. Anderson Cancer Center
Teva Pharmaceuticals USA

Investigators

  • Principal Investigator: Patricia Kropf, MD, Temple University Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Actual)

June 26, 2018

Study Completion (Actual)

April 16, 2020

Study Registration Dates

First Submitted

July 11, 2014

First Submitted That Met QC Criteria

July 14, 2014

First Posted (Estimate)

July 15, 2014

Study Record Updates

Last Update Posted (Actual)

May 19, 2021

Last Update Submitted That Met QC Criteria

May 18, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21357

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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