AML Therapy With Irradiated Allogeneic Cells

Stopped early · Not applicable

Conditions studied: Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Recurrent Adult Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia

In brief

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).

Key facts

Study ID

NCT02105116

Run by

Rutgers, The State University of New Jersey

People needed

6

Starts

2014-02-01

Expected to finish

2015-12-16

Last updated by the study team

2021-08-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

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