Donor Natural Killer Cells After Donor Stem Cell Transplant in Treating Patients With Advanced Cancer

Lymphoma Clinical Trial

Official title:

Donor NK Cell Infusion for Progression/Recurrence of Underlying Malignant Disorders After HLA-haploidentical HCT - a Phase 1-2 Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00823524
• Other study ID #: CDR0000632275
• Secondary ID: AMC-UUCM-2008-03
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 14, 2009
• Last updated: February 18, 2013
• Start date: January 2009
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Giving an infusion of natural killer cells from a donor after a donor stem cell transplant may help kill any remaining cancer cells after the transplant.

PURPOSE: This phase I/II trial is studying the side effects and best dose of donor natural killer cells when given after a donor stem cell transplant in treating patients with advanced cancer.

Description:

OBJECTIVES:

Primary

• To assess the safety of donor natural killer (NK) cell infusion after HLA-mismatched/haploidentical allogeneic hematopoietic stem cell transplantation from a familial donor in patients with advanced malignant disorders.

• To determine the maximum number of donor NK cells that can be safely given to these patients.

Secondary

• To assess the clinical efficacy donor NK cell infusion, in terms of tumor response, response duration, and survival, in patients with progressive or recurrent malignant disorders.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

• Phase I: Patients receive an infusion of donor natural killer (NK) cells on days 18 and 21.

• Phase II: Patients receive an infusion of donor NK cells on days 14 and 21. After completion of study treatment, patients are followed periodically.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 75 Years

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of a malignant disorder (hematologic malignancies or solid tumors)

• Advanced disease

• Has undergone prior allogeneic hematopoietic stem cell transplantation (HSCT) from an HLA-mismatched/haploidentical familial donor

• Progressive or recurrent disease, as defined by any of the following (phase II):

• Peripheral blood blast > 20% with bone marrow aspirate showing > 5% leukemic cells (in patients with acute leukemia)

• Detection of metaphases in the marrow with the same clonal cytogenetic abnormalities as identified before HSCT (or by FISH markers, if appropriate) (in patients with acute leukemia or high-risk myelodysplastic syndromes [MDS])

• Persistent cytopenia with bone marrow aspirate showing various degrees of dysplasia involving = 1 cell lineage (in patients with high-risk MDS)

• Enlargement of pre-existing measurable lesions by 20% according to RECIST criteria (in patients with solid tumors or lymphoma)

• Appearance of new metastatic lesions, including pleural effusion or ascites, radiologically typical for metastases or confirmed as such by cytology (in patients with solid tumors or lymphoma)

• Measurable disease (phase II)

PATIENT CHARACTERISTICS:

• Karnofsky performance status 70-100%

• Total bilirubin < 3.0 mg/dL

• AST < 5 times upper limit of normal

• Creatinine < 3 mg/dL

• Not pregnant or nursing

• No clinically evident cardiac or pulmonary failure

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Chronic Myeloproliferative Disorders
• Disease
• Leukemia
• Lymphoma
• Lymphoproliferative Disorder
• Lymphoproliferative Disorders
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasms
• Myeloproliferative Disorders
• Neoplasms
• Neoplasms, Plasma Cell
• Nervous System Neoplasms
• Plasmacytoma
• Preleukemia
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Biological:
• donor natural killer cell infusion
give patients donor-derived NK cells 2 to 3 weeks after HLA-haploidentical hematopoietic cell transplantation

Locations

Country	Name	City	State
Korea, Republic of	University of Ulsan, Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Korea Research Institute of Bioscience & Biotechnology

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Safety will be evaluation in terms of transplantation outcomes as well as side effects of donor NK cell infusion	15 days to 1 year after transplantation	Yes
Secondary	Clinical efficacy of donor NK cell infusion, in terms of tumor response, response duration, and survival	achievement of CR of underlying disease, CR duration	15 days to 1 year	No