Expired Study
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New Brunswick, New Jersey 08903


Purpose:

This pilot clinical trial studies if cells donated by a close genetic relative can help keep acute myeloid leukemia (AML) from coming back after standard chemotherapy induces a complete remission. Blood cells obtained from a donor include a variety of blood cells that may trigger the patient's immune system to react against AML cells.


Study summary:

PRIMARY OBJECTIVES: I. Toxicity of haploidentical allogeneic cellular therapy in patients in complete remission (CR) (or CR with incomplete platelet recovery [CRp]) after induction chemotherapy with fludarabine (fludarabine phosphate)-cytarabine. II. Efficacy of haploidentical allogeneic cellular therapy in patients in CR (or CRp) after induction chemotherapy with fludarabine-cytarabine (remission rates at 6, 12, 18, 24 months). SECONDARY OBJECTIVES: I. Immunologic parameters before and after haploidentical therapy: host anti-leukemia T cells; host regulatory T cells. OUTLINE: INDUCTION CHEMOTHERAPY: Patients receive fludarabine phosphate intravenously (IV) over 1 hour once daily (QD) for 5 days and cytarabine IV over 4 hours for 5 days. Treatment may continue for 1 or 2 courses at the discretion of the treating physician. ALLOGENEIC CELLULAR THERAPY: Patients undergo irradiated donor lymphocyte infusion (DLI) of 3 x 10^8 cluster of differentiation (CD)3+ cells/kg at 8 weeks. Patients with stable disease may repeat irradiated DLI every 8-12 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically for up to 2 years.


Criteria:

Inclusion Criteria: - Histologically proven non-M3 AML: - Refractory/relapsed AML OR - Initial diagnosis of AML in patient >= 60 years old - Total bilirubin =< 1.5 times upper limit of normal (ULN) institutional limits (unless Gilbert's disease) - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional ULN - Cardiac left ventricular ejection fraction (LVEF) >= 35% - Serum creatinine =< 1.5 mg/dl - Any organ dysfunction thought to be secondary to disease will be considered separately and the patient will be included at the investigators discretion - Patients must give informed consent - Eastern Cooperative Oncology Group (ECOG) performance status =< 3 - Must have a potential haploidentical donor (parent, sibling, child) - A patient is eligible for second enrollment (allo-cellular therapy) if all of the following inclusion criteria are met: - Patient must have documented CR or CRp after 1 or 2 cycles of fludarabine + cytarabine - Patient must not be a candidate for an allo-hematopoietic stem cell transplant (HSCT) - Patient must have a partially (>= 3/6 class I antigen) human leukocyte antigen (HLA)-matched (by serology or low resolution deoxyribonucleic acid [DNA] testing) relative able to serve as a donor - Patients must not have active uncontrolled infections, other medical or psychological/social conditions that might increase the likelihood of patient adverse effects or poor outcomes - Total bilirubin < 1.5 times upper limit of normal (ULN) institutional limits (unless Gilbert's disease) - AST(SGOT)/ALT(SGPT) =< 2.5 X institutional ULN - Serum creatinine < 2.0 mg/dl - ECOG performance status =< 2 - DONOR: donor must be related to patient and be partially (>= 3/6 antigen) HLA-matched - DONOR: donor must meet all New Brunswick Affiliated Hospitals (NBAH) requirements for hematopoietic stem cell donation, including: - DONOR: age >= 18 years old - DONOR: white blood cells (WBC) 4.0-10.0 x 10^3/mm^3 - DONOR: platelet count 150,000 to 440,000/mm^3 - DONOR: hemoglobin/hematocrit; 12.5-18 g/dl, 38 to 54% - DONOR: not pregnant or lactating - DONOR: not human immunodeficiency virus (HIV)-1, HIV-2, hepatitis C virus (HCV), hepatitis B core or human T-lymphotropic virus (HTLV)-I/II seropositive; hepatitis B surface antigen (HB S ag) (-); meet other infectious disease screening criteria utilized by NBAH Blood Center - DONOR: no uncontrolled infections, other medical or psychological/social conditions, or medications that might increase the likelihood of patient or donor adverse effects or poor outcomes - DONOR: meet other blood bank criteria for blood product donation (as determined by NBAH Blood Center screening history and laboratory studies) Exclusion Criteria: - History of current or prior medical problems that the investigator feels will prevent administration of therapy or assessment of response due to excess toxicity - Patients with known active central nervous system (CNS) leukemia will be excluded from this clinical study - Known HIV-positive patients are excluded from the study - Patients may not be pregnant or breast feeding


NCT ID:

NCT02105116


Primary Contact:

Principal Investigator
Roger Strair, MD, PhD
Rutgers Cancer Institute of New Jersey


Backup Contact:

N/A


Location Contact:

New Brunswick, New Jersey 08903
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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