AML Therapy With Irradiated Allogeneic Cells

• Status: Terminated
• Trial end date: 2015-12-16
• Target enrollment: 0
• Participant gender: All

Summary

This pilot clinical trial studies if cells donated by a close genetic relative can help maintain acute myeloid leukemia (AML) complete remission (CR). Eligible patients will receive a standard induction chemotherapy. If a complete remission results they will receive irradiated allogeneic cells from a HLA haploidentical relative. Only patients who obtain a CR after the standard induction chemotherapy are eligible for the experimental therapy (irradiated haploidentical cells).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Cancer Institute (NCI); Rutgers Cancer Institute of New Jersey
• Treatments: Cytarabine; Fludarabine; Fludarabine phosphate; Vidarabine

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