AML Therapy With Irradiated Allogeneic Cells
Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a)
About this trial
This is an interventional treatment trial for Adult Acute Megakaryoblastic Leukemia (M7)
Eligibility 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
Sites / Locations
- Rutgers Cancer Institute of New Jersey
Arms of the Study
Arm 1
Experimental
Standard chemotherapy followed by allogenic therapy
INDUCTION CHEMOTHERAPY: Patients receive standard induction chemotherapy with fludarabine phosphate IV over 1 hour QD for 5 days and cytarabine IV over 4 hours for 5 days. G-CSF 5 mcg/kg will be started at day14 if day14 bone marrow does not have >5% leukemic blasts. Treatment may continue for 1 or 2 courses at the discretion of the treating physician. If the patient enters a complete remission they are eligible for ALLOGENEIC CELLULAR THERAPY: Patients eligible for the experimental therapy undergo irradiated Donor Lymphocyte Infusion (DLI) of 3 x 10^8 CD3+ 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.