T-cell Depleted Donor Lymphocyte Infusion (DLI)for Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)

NCT00242515 | Unknown Phase 1

• 1 other identifier: TP02/28/04
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives: This a pilot project to determine the feasibility of the preemptive CD8+ depleted T-cell donor lymphocyte infusion (DLI) in:

• Reducing the incidence of graft versus host disease (GVHD) based on standard classification of acute and chronic GVHD
• Improving hte disease remission rate in comparison with our previous study results. Secondary Objectives:
• To investigate the impact of CD8+ depleted T-cell DLI in hematopoietic chimerism, and immunologic recovery of transplant patients.

Conditions

Acute Myeloid Leukemia; Myelodysplastic Syndromes

Keywords

High risk Myelodysplastic Syndrome (MDS)

Outcome Measures

Primary Outcomes (2)

• Incidence rate of acute and chronic GVHD

• Disease remission rate post CD8+ depleted T-cell DLI

Secondary Outcomes (1)

• Hematopoietic chimerism and immunologic recovery post CD8+ depleted T-cell DLI

Interventions

CD8+ T-cell depleted donor lymphocyte infusion PROCEDURE

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of AML or high risk MDS in the following disease stages: Induction failure, first or subsequent remission, or untreated first relapse.
• Patient must have an HLA-compatible donor willing and capable of donating peripheral blood stem cells preferably or bone marrow progenitor cells using conventional techniques, and lymphocytes if indicated (HLA-compatible defined as 5/6 or 6/6 matched related or 6/6 molecular matched unrelated donor)
• Both patient and donor must sign written informed consent forms.
• Patients must have:
• ECOG PS \</= 2;
• Ejective fraction \> 40%;
• DLCO \> 40% of predicted;
• Serum bilirubin \</= 1.5x institutional upper limit of normal;
• SGPT (ALT) and SGOT (AST) \</= 2.5x institutional upper limit of normal;
• Serum creatinine \</= 2x upper limit of normal;
• Creatinine clearance \>/= 60mL/min. However, renal dysfunction is not an absolute contraindication for NMT as dialysis can be performed during NMT.

You may not qualify if:

• Active life-threatening infection
• Overt untreated infection
• HIV positivity, hepatitis B or C antigen positivity with active hepatitis
• Pregnant or lactating women
• Donor contraindication (HIV seropositive confirmed by Western blot; hepatitis B antigenemia)
• Unable to donate bone marrow or peripheral blood due to concurrent medical condition

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• Singapore General Hospital: collaborator

Study Sites (1)

Department of Hematology-Oncology, National University Hospital

Singapore, 119074, Singapore

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

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

Study Officials

• Chien-Shing Chen, MD

  National University Hospital/National University Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chien-Shing Chen, MD

CONTACT

67724613; mdcccs@nus.edu.sg

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: October 19, 2005
• First Posted: October 20, 2005
• Study Start: March 1, 2005
• Study Completion: March 1, 2008
• Last Updated: January 8, 2014

Record last verified: 2014-01

Locations

SG (1)