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Phase 1/2 Study of Decitabine Combined With Modified CAG Followed by HLA Haploidentical T Cell Infusion in Treating Elderly Patients With Intermediate-high Risk Myelodysplastic Syndrome(MDS) or Acute Myeloid Leukemia(AML)


Phase 1/Phase 2
60 Years
75 Years
Open (Enrolling)
Both
MDS, AML

Thank you

Trial Information

Phase 1/2 Study of Decitabine Combined With Modified CAG Followed by HLA Haploidentical T Cell Infusion in Treating Elderly Patients With Intermediate-high Risk Myelodysplastic Syndrome(MDS) or Acute Myeloid Leukemia(AML)


PATIENT

Inclusion Criteria:



- Must have a diagnosis of MDS-RAEB or AML based on 2008 World Health Organization
(WHO) classification of myeloid malignancies

- Must have life expectancy >= 3 months

- Must have the ability to observe the efficacy and events

- Must have no accompany therapy(including steroid)

- Patient must have ability to understand and willingness to provide written informed
consent prior to participation in the study and any related procedures being
performed

- Must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 3

- Must have haploidentical donor

DONOR

Inclusion Criteria:



- Must have signed the standard informed consent form; if sufficient cryopreserved
cells remain from a previous donation, no additional donation or consent is required

- Both men and women and members of all races and ethnic groups are eligible for this
trial

PATIENT Exclusion Criteria:

- Must not have an advanced malignant hepatic tumor

- Must not receive any other forms of chemotherapy after cell infusion during the
treatment protocol

- Must not be receiving any other investigational agents within 14 days of first dose
of study drug

- Must not have uncontrolled intercurrent illness including ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, or
psychiatric illness/social situations that would limit compliance with study
requirements

- Must not be pregnant or breastfeeding; pregnant women are excluded from this study
because decitabine is a Category D agent with the potential for teratogenic or
abortifacient effects; because there is an unknown but potential risk for adverse
events in nursing infants secondary to treatment of the mother with decitabine,
breastfeeding should be discontinued if the mother is treated with decitabine; these
potential risks may also apply to other agents used in this study

- Must not have a history of allergic reactions attributed to compounds of similar
chemical or biologic composition to decitabine or other agents used in the study

- Must not have a known or suspected hypersensitivity to decitabine

- Must not be human immunodeficiency virus (HIV)-positive and on combination
antiretroviral therapy; these patients are ineligible because of the potential for
pharmacokinetic interactions with decitabine; in addition, these patients are at
increased risk of lethal infections when treated with marrow-suppressive therapy;
appropriate studies will be undertaken in patients receiving combination
antiretroviral therapy when indicated

DONOR Exclusion Criteria:

- Must not have any underlying conditions which would contra-indicate apheresis

- Must not be pregnant

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Li Yu, M.D. Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chinese PLA General Hospital

Authority:

China: Ethics Committee

Study ID:

CN301-XYK-001

NCT ID:

NCT01690507

Start Date:

November 2012

Completion Date:

November 2016

Related Keywords:

  • MDS
  • AML
  • demethylating agent
  • immunogenicity
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

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