Clinical Trials /

Leukemia SPORE Phase II 3-arm DAC Randomized Study for R/R and Elderly Acute AML and MDS

NCT02190695

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
  • Chronic Myelomonocytic Leukemia
  • Myelodysplastic Syndromes
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Leukemia SPORE Phase II 3-arm DAC Randomized Study for R/R and Elderly Acute AML and MDS
  • 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)

Clinical Trial IDs

  • ORG STUDY ID: 21357
  • NCT ID: NCT02190695
  • NCT ALIAS: NCT02188706

Conditions

  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
  • Chronic Myelomonocytic Leukemia

Interventions

DrugSynonymsArms
DecitabineDacogenDecitabine
Carboplatincis-Diammine, Paraplatin, Paraplatin-AQDecitabine and Carboplatin
Arsenic trioxideATODecitabine and Arsenic

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
DecitabineActive ComparatorDecitabine 20mg/m2 IV over 1hour daily times 5 days every 28 days
  • 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.
  • Decitabine
  • 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
  • Decitabine
  • Arsenic trioxide

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Time to complete or partial remission
Time Frame:up to 16 weeks
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Temple University

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