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

NCT02190695 | Completed Phase 2

• 1 other identifier: 21357
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Myeloid Leukemia; Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia

Outcome Measures

Primary Outcomes (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.

  up to 16 weeks

Study Arms (3)

Decitabine

ACTIVE COMPARATOR

Decitabine 20mg/m2 IV over 1hour daily times 5 days every 28 days

Drug: Decitabine

Decitabine and Carboplatin

EXPERIMENTAL

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; Drug: Carboplatin

Decitabine and Arsenic

EXPERIMENTAL

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; Drug: Arsenic trioxide

Interventions

Decitabine DRUG

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

Also known as: Dacogen

Decitabine; Decitabine and Arsenic; Decitabine and Carboplatin

Carboplatin DRUG

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

Also known as: cis-Diammine, Paraplatin, Paraplatin-AQ

Decitabine and Carboplatin

Arsenic trioxide DRUG

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

Also known as: ATO

Decitabine and Arsenic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• M.D. Anderson Cancer Center: collaborator
• Teva Pharmaceuticals USA: collaborator

Study Sites (2)

Temple BMT Program at Jeanes Hospital

Philadelphia, Pennsylvania, 19111, United States

Location

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 40453133 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic

Interventions

Decitabine; Carboplatin; Arsenic Trioxide

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Myelodysplastic-Myeloproliferative Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Coordination Complexes; Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds

Study Officials

• Patricia Kropf, MD

  Temple University Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2014
• First Posted: July 15, 2014
• Study Start: April 1, 2013
• Primary Completion: June 26, 2018
• Study Completion: April 16, 2020
• Last Updated: May 19, 2021

Record last verified: 2021-05

Locations

US (2)