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

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ClinicalTrials.gov Identifier: NCT02190695
Recruitment Status : Unknown
Verified April 2017 by Temple University.
Recruitment status was:  Recruiting
First Posted : July 15, 2014
Last Update Posted : April 27, 2017
Sponsor:
Collaborators:
M.D. Anderson Cancer Center
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Temple University

Study Description
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Brief 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. The investigators are looking at both the safety and Efficacy of each combination.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Myelodysplastic Syndrome Chronic Myelomonocytic Leukemia Drug: Decitabine Drug: Carboplatin Drug: Arsenic trioxide Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : April 2013
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Dacogen

Drug: Carboplatin
AUC 5 by vein over 1 hour on Day 8 of each 28 day cycle.
Other Names:
  • cis-Diammine
  • Paraplatin
  • 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 Name: Dacogen

Drug: Arsenic trioxide
0.15 mg/kg by vein over 1 hour on Days 1-5 of each 28 day cycle.
Other Name: ATO


Outcome Measures
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Primary Outcome Measures :
  1. Time to complete or partial remission [ Time Frame: up to 16 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02190695


Contacts
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Contact: Lilanee Chanyothi, RN, BSN 215-214-3035 Lilanee.Chanyothi@tuhs.temple.edu

Locations
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United States, Pennsylvania
Temple BMT Program at Jeanes Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19111
Principal Investigator: Patricia Kropf, MD         
Principal Investigator: Jean-Pierre Issa, MD         
Sub-Investigator: Stefan Barta, MD         
Sub-Investigator: Philip Pancari, MD         
Sub-Investigator: Henry Fung, MD         
United States, Texas
M.D. Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Alexandra Thackrey, RN- BC    713-745-2238    AMThackrey@mdanderson.org   
Principal Investigator: Hagop Kantarjian, MD         
Sponsors and Collaborators
Temple University
M.D. Anderson Cancer Center
Teva Pharmaceuticals USA
Investigators
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Principal Investigator: Patricia Kropf, MD Temple University Health System
More Information
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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT02190695     History of Changes
Obsolete Identifiers: NCT02188706
Other Study ID Numbers: 21357
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Syndrome
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
 Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Myelodysplastic-Myeloproliferative Diseases
Carboplatin
Decitabine
Arsenic Trioxide
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors