NCT00986804

Brief Summary

Primary: To determine the maximum tolerated dose and schedule of decitabine when administered as maintenance therapy after allogeneic hematopoietic stem cell transplantation (alloHSCT) performed for AML or high-risk MDS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 15, 2016

Status Verified

February 1, 2016

Enrollment Period

4.4 years

First QC Date

September 29, 2009

Last Update Submit

February 11, 2016

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic Syndromes

Outcome Measures

Primary Outcomes (1)

  • To determine the maximum tolerated dose and schedule of decitabine when administered as maintenance therapy after alloHSCT performed for AML or high-risk MDS.

    Up to 6 weeks (completion of first cycle)

Secondary Outcomes (11)

  • To determine the safety and tolerability of decitabine as maintenance therapy after alloHSCT.

    Up to 30 days after end of study (approximately 46 weeks)

  • To determine the rates disease relapse

    Every 3 months for 2 years then every 6 months for 3 years

  • To assess lymphoid and myeloid chimerism while on decitabine maintenance.

    End of cycle 3 (18 weeks)

  • To determine the incidence of acute GVHD.

    End of study (42 weeks)

  • To assess immunologic reconstitution after alloHSCT.

    End of study (42 weeks)

  • +6 more secondary outcomes

Study Arms (4)

Level 1

EXPERIMENTAL

Decitabine 5.0 mg/m2/day on Days 1 thru 5 every 6 weeks for as many as 8 cycles.

Drug: Decitabine

Level 2

EXPERIMENTAL

Decitabine 7.5 mg/m2/day on Days 1 thru 5 every 6 weeks for as many as 8 cycles.

Drug: Decitabine

Level 3

EXPERIMENTAL

Decitabine 10.0 mg/m2/day on Days 1 thru 5 every 6 weeks for as many as 8 cycles.

Drug: Decitabine

Level 4

EXPERIMENTAL

Decitabine 15.0 mg/m2/day on Days 1 thru 5 every 6 weeks for as many as 8 cycles.

Drug: Decitabine

Interventions

DecitabineDRUG
Also known as: Dacogen
Level 1Level 2Level 3Level 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Study will include maximum of 32 evaluable patients.
  • History of AML or MDS using WHO classification.
  • \>50 and \<100 days following HLA-matched related or unrelated donor alloHSCT. Donors may be mismatched at single antigen at HLA-A, -B or -DR locus plus possible single antigen mismatch at HLA-C according to institution guidelines. Two-antigen mismatch at a single locus is not allowed.
  • Age \>=18 years.
  • Bone marrow biopsy confirming complete remission after alloHSCT
  • o Complete remission: less than 5% blasts in an aspirate bone marrow sample with a count of at least 200 nucleated cells, no blasts with Auer rods or persistence of extramedullary disease PLUS absolute neutrophil count (ANC) \> 1,500/μL, platelet count ≥ 50,000/μL and no leukemic blasts in the peripheral blood.
  • Platelet count ≥ 50,000/µL without platelet transfusion for 7 days and ANC ≥ 1,500/µL without colony stimulating factor support.
  • Performance status \< ECOG 2.
  • Acceptable organ function defined as:
  • creatinine \< 1.5 times the institutional ULN or creatinine clearance (calculated by the Cockroft and Gault method) ≥ 30 mL/min
  • bilirubin \< 1.5 times the institutional ULN
  • AST, ALT and alkaline phosphatase \< 2.5 times the institutional ULN.
  • Each Patient or their legal authorized representative must sign an institutional review board/ethics committee-approved informed consent indicating their awareness of the investigational nature of this study.
  • Female Subjects:
  • Female of childbearing potential (FCBP\*) must agree to use a reliable form of contraception or to practice complete abstinence from heterosexual intercourse for at least 28 days before starting study drug, while participating in the study, and for at least 28 days after discontinuation from the study. The methods of reliable contraception include intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation, partner's vasectomy, latex condom, diaphragm and cervical cap.
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (4)

  • Blum W, Bruner-Klisovic R, Liu S, et al. Phase I Study of Low Dose Decitabine in Patients with Acute Myeloid Leukemia (AML): Pharmacokinetics (PK), Pharmacodynamics (PD), and Clinical Activity. ASH Annual Meeting Abstracts. 2005;106:1861-.

    BACKGROUND

  • Kantarjian H, Issa JP, Rosenfeld CS, Bennett JM, Albitar M, DiPersio J, Klimek V, Slack J, de Castro C, Ravandi F, Helmer R 3rd, Shen L, Nimer SD, Leavitt R, Raza A, Saba H. Decitabine improves patient outcomes in myelodysplastic syndromes: results of a phase III randomized study. Cancer. 2006 Apr 15;106(8):1794-803. doi: 10.1002/cncr.21792.

    PMID: 16532500BACKGROUND

  • Choi J, Ritchey J, DiPersio J. Generation of Treg-Like Cells from CD4+CD25- T Cells Via Epigenetic Modification Using a Demethylating Agent Decitabine. ASH Annual Meeting Abstracts. 2007;110:62-.

    BACKGROUND

  • De Lima M, de Padua Silva L, Giralt S, et al. Maintenance Therapy with Low-Dose Azacitidine (AZA) after Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Relapsed or Refractory AML or MDS: A Dose and Schedule Finding Study. ASH Annual Meeting Abstracts. 2008;112:1134-.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic Syndromes

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Intervention Hierarchy (Ancestors)

AzacitidineAza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Iskra Pusic, M.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2009

First Posted

September 30, 2009

Study Start

December 1, 2009

Primary Completion

May 1, 2014

Study Completion

February 1, 2016

Last Updated

February 15, 2016

Record last verified: 2016-02

Locations

US(1)