PURPLE-D: Decitabine for Chemotherapy Unfit Korean AML Patients in Real Practice

Sponsor

Ulsan University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT02698124

Collaborator

The Korean Society of Hematology, AML/MDS Working Party (Other)

136

Enrollment

Location

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prospective multicenter, open-lab el, observational, single arm study of decitabine. Subjects will be elderly patients with newly diagnosed, treatment-naïve AML who are unfit to receive and not candidate for intensive induction chemotherapy (iIC)

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia Elderly Intensive Chemotherapy Unfit	Drug: Decitabine

Study Design

Study Type:

Observational

Anticipated Enrollment :

136 participants

Observational Model:

Ecologic or Community

Time Perspective:

Prospective

Official Title:

Prospective Observation of the indUction Regimen for Acute Non-Promyelocytic Myeloid Leukemia in Elderly; Decitabine for Chemotherapy Unfit Korean Acute Myeloid Leukemia (AML) Patients in Real Practice

Study Start Date :

Mar 1, 2016

Anticipated Primary Completion Date :

Aug 1, 2019

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Decitabine Decitabine 20mg/m2 will be given IV daily on Days 1-5 in 28-day cycles. Treatment should be given for at least 4 cycles in the absence of unacceptable toxicity or disease progression requiring alternative therapy. Beyond 4 cycles, treatment should continue as long as the subject continues to benefit based on investigator's judgment of no definitive progression.	Drug: Decitabine

Arm

Intervention/Treatment

Decitabine

Decitabine 20mg/m2 will be given IV daily on Days 1-5 in 28-day cycles. Treatment should be given for at least 4 cycles in the absence of unacceptable toxicity or disease progression requiring alternative therapy. Beyond 4 cycles, treatment should continue as long as the subject continues to benefit based on investigator's judgment of no definitive progression.

Drug: Decitabine

Outcome Measures

Primary Outcome Measures

The rate of complete remission [after 4 cycles of decitabine treatment (about 4 months)]
The rate of complete remission and complete remission with incomplete platelet recovery (CRp) will be measured by 4 cycles of decitabine treatment.

Secondary Outcome Measures

The rate of composite CR [after 4 cycles of decitabine treatment (about 4 months)]
CR+CRp+ CR with incomplete blood count recovery (CRi)
Clinical benefit rate [after 4 cycles of decitabine treatment (about 4 months)]
cCR(CR+CRp+CRi)+ partial remission (PR)+ stable disease (SD)
Change of quality of life scale using EQ-5D-3L [after 4 cycles of decitabine treatment (about 4 months)]
Quality of life measurement by EQ-5D will be compared between pre- and post-decitabine therapy.
Change of quality of life scale using EORTC QLQ-C30 [after 4 cycles of decitabine treatment (about 4 months)]
Quality of life measurement by EORTC QLQ-C30 will be compared between pre- and post-decitabine therapy.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [until 4 cycles of decitabine treatment (about 4 months)]
CTCAE version 4.03

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Newly diagnosed and therapy-naïve AML (bone marrow or peripheral blood blast counts ≥20%)
65 years of age or older
Taking informed consent with signature and date
Not eligible for iIC based on either:

≥75 years of age ii) comorbidity iii) secondary AML iv) poor performance (ECOG ≥2) v) Poor-risk by NCCN Guideline version 1.2015 vi) subject's choice (refusal for iIC) investigator's judgement incompatible with iIC

Exclusion Criteria:

Candidate for iIC at the time of enrollment
Promyelocytic leukemia, or AML with t(15;17) or PML/RARα rearrangement
AML with t(9;22) or BCR/ABL rearrangement
Leukemia central nervous system involvement
Extramedullary myeloid sarcoma without bone marrow involvement
Prior treatment with decitabine or azacitidine of any cause
Any leukemia-specific therapy, except for hydroxyurea for reducing leukemic cells prior decitabine
Second malignancy currently requiring active therapy except breast or prostate cancer stable on or responding to endocrine therapy, or curatively resected non-melanoma skin cancer or intraepithelial cancer
Premenopausal woman
Severe active infection
Uncontrolled bleeding Hypersensitivity to decitabine

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ulsan University Hospital	Ulsan		Korea, Republic of	682714

Sponsors and Collaborators

Ulsan University Hospital
The Korean Society of Hematology, AML/MDS Working Party

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hawk Kim, Professor, Ulsan University Hospital

ClinicalTrials.gov Identifier:

NCT02698124

Other Study ID Numbers:

AMLMDSWP-201601

First Posted:

Mar 3, 2016

Last Update Posted:

Mar 7, 2016

Last Verified:

Mar 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Decitabine

Study Results

No Results Posted as of Mar 7, 2016