Safety Study of 5-Azacitidine and Standard Donor Lymphocyte Infusion (DLI) to Treat Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) Relapsing After Allogeneic Stem Cell Transplantation

NCT00795548 | Completed Phase 2

• 1 other identifier: AZARELA_HHU_2007
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

Brief Summary

This open label phase-II trial evaluates hematological response of an additional treatment with 5-Azacitidine to common DLI in patients with MDS or AML relapsing after allogeneic stem cell transplantation.

Conditions

Myelodysplastic Syndrome; Acute Myeloid Leukemia

Keywords

Myelodysplastic syndrome (MDS); Acute myeloid leukemia (AML); Stem cell transplantation; 5-Azacitidine; Donor lymphocyte infusion; MDS or AML relapsed after stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• Best response

  within the 6 months of treatment

Secondary Outcomes (6)

• Safety and Toxicity of 5-Azacitidine for patients relapsing after allo-SCT

  within 3 years

• Response rate

  within 6 months

• Duration of remissions

  within 3 years

• Incidence of acute and chronic GvHD

  3 years

• Achievement of complete chimerism

  6 month

Study Arms (1)

5-Azacitidine

EXPERIMENTAL

5-Azacitidine in addition to standard donor lymphocyte infusions.

Drug: 5-Azacitidine

Interventions

5-Azacitidine DRUG

5-Aza will be administered at doses of 100mg/m2 via subcutaneous injection over a period of 5 days. The total amount per treatment cycle, consisting of 5 days, is 500mg/m². Each treatment cycle is repeated every 28 days, with a treatment pause of 23 days between each 5-Aza cycle, to a total of 6 (optional 8 cycles) cycles. DLI will be transfused on day +34 with a total count of CD3+ cells of DLI 1-5x10E6CD3+/kg bodyweight. In absence of GvHD DLI transfusion is repeated on day +90 with DLI 1-5x10E7CD3+/kg bodyweight and on day +142 with DLI 1-5x10E8CD3+/kg bodyweight. Additional DLI may be given.

Also known as: Vidaza

5-Azacitidine

Eligibility Criteria

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

You may qualify if:

• \- Primary and secondary MDS, AML after MDS, and de novo AML relapsing after allogeneic stem cell transplantation
• Eligibility for Donor Lymphocyte Infusions
• Performance status according to the WHO scale: 0, 1 or 2.
• Adequate renal and liver function: bilirubin \< 1.5 times the upper limit of normal and a GFR \> 50 ml/min
• Absence of severe cardiovascular disease, i.e., arrhythmias requiring chronic treatment, congestive heart failure (NYHA Class III or IV) or symptomatic ischemic heart disease, where New-York Heart Association (NYHA)
• HIV negative and HBs-Ag negative.
• Absence of active uncontrolled infection (Septicaemia).
• No prior history or current evidence of central nervous system and psychiatric disorders requiring hospitalization.
• Age at least 18 years.
• Negative pregnancy test for women with reproductive potential.
• Signed written informed consent must be given according to national/local regulations.

You may not qualify if:

• \- Have malignant hepatic tumors.
• Severe liver dysfunction CHILD B and C.
• Renal insufficiency with a GFR \< 50 ml/min
• Radiation therapy, chemotherapy, or cytotoxic therapy, given to treat conditions other than MDS, AML or applied for conditioning prior allogeneic stemcell transplantation.
• Psychiatric illness that would prevent granting of informed consent.
• Treatment with androgenic hormones during the previous 14 days prior Day 1.
• Active viral infection with known human immunodeficiency virus (HIV) or viral Hepatitis B or C.
• Hypersensitivity to Mannitol or 5-Azacitidine.
• Treatment with other investigational drugs following relapse after allogeneic stemcell transplantation or ongoing adverse events from previous treatment with investigational drugs regardless of time period.

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (6)

Universitaetsklinik Heidelberg, Medizinische Klinik und Poliklinik V

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Bone Marrow Transplantation Unit, University Hospital Hamburg-Eppendorf

Hamburg, Hamburg, 20246, Germany

Location

Klinikum der Johann-Wolfgang-Goethe Universität, Medizinische Klinik II

Frankfurt am Main, Hesse, 60590, Germany

Location

Department of Hematology, Oncology and Clinical Immunology, University Hospital Duesseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Universitaetsklinikum Dresden, Medizinische Klinik und Poliklinik I

Dresden, Saxony, 01307, Germany

Location

Charite´-Campus Benjamin Franklin, Medizinische Klinik III

Berlin, State of Berlin, 01220, Germany

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia, Myeloid, Acute

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Guido Kobbe, PD Dr.

  Department of Hematology, Oncology and Clinical Immunology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 21, 2008
• Study Start: November 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: August 1, 2011
• Last Updated: January 23, 2012

Record last verified: 2012-01

Locations

DE (6)