Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Active	15 to 75	Other	AMC-UUCM-2008-0383 2008-0383, NCT00823524

Objectives

Primary

1. 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.
2. To determine the maximum number of donor NK cells that can be safely given to these patients.

Secondary

1. 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.

Entry Criteria

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)

Prior/Concurrent Therapy:

• See Disease Characteristics

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

Expected Enrollment

Outcomes

Safety
Maximum number of donor natural killer (NK) cells that can be safely given

Clinical efficacy of donor NK cell infusion, in terms of tumor response, response duration, and survival

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.

Trial Contact Information

Trial Lead Organizations

Asan Medical Center - University of Ulsan College of Medicine

Kyoo Lee, MD, Principal investigator		Ph: 82-2-2224-3210 Email: khlee2@amc.seoul.kr

Republic of Korea
	Seoul
	Asan Medical Center - University of Ulsan College of Medicine
		Kyoo Lee, MD	Ph:  82-2-2224-3210
			Email: khlee2@amc.seoul.kr

Registry Information
Official Title		Donor NK cell infusion for progression/recurrence of underlying malignant disorders after HLA-haploidentical HCT - a phase 1-2 study
Trial Start Date		2009-01-07
Trial Completion Date		2012-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00823524
Date Submitted to PDQ		2009-01-07
Information Last Verified		2009-01-13