T-Cell Infusion and Donor Stem Cell Transplant in Treating Patients with High-Risk Hematologic Cancer

Inclusion Criteria

• Karnofsky or Lansky performance status >= 70%
• Subjects must have histologically documented acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS), myeloproliferative disorders (MPD), chronic myeloid leukemia (CML), non-Hodgkin lymphoma (NHL), Hodgkin lymphoma (HL) or multiple myeloma (MM) as follows: * Acute myeloid leukemia (AML) with one or more of the following criteria: ** Poor risk cytogenetics, including -5, 5q-, -7, 7q-, t(9;22); complex cytogenetics (>= 3 abnormalities); or normal cytogenetics with Fms-like tyrosine kinase 3 (Flt3) internal tandem duplications (ITD), in first or subsequent complete remission (CR) ** Relapsed or primary refractory AML with =< 10% blasts in the peripheral blood ** Subjects in CR1 who required two cycles of induction to achieve remission may be included at the discretion of the treating physician ** Standard risk or intermediate risk cytogenetics in second or subsequent CR (enrolled at the discretion of the treating physician) * Acute lymphoblastic leukemia (ALL) with one of the following criteria: ** Second or subsequent CR ** Any partial remission (PR) (no circulating blasts) ** High-risk ALL in first CR including (Philadelphia chromosome positive [Ph+], t(4:11)), complex karyotype, hypodiploidy (< 44 chromosomes), positive minimal residual disease (MRD) after induction, and other high risk features in adults per treating physician * Myelodysplasia, intermediate-2 (score 1.5-2.0) or high risk (score > 2.5) by the International Prognostic Score System * Myeloproliferative disorders (include chronic myelomonocytic leukemia [CMML], agnogenic myeloid metaplasia [AMM] or idiopathic myelofibrosis, and juvenile myelomonocytic leukemia [JMML]) with excess blasts (> 5%) * Chronic myeloid leukemia (CML) with one of the following criteria: ** Second or subsequent chronic phase ** Accelerated phase ** Blast crisis * Non-Hodgkin's lymphoma (NHL) meeting one of the following criteria: ** Relapse after autologous stem cell transplantation with evidence of responsive disease ** Subject with chemosensitive relapse who have no option for autologous stem cell transplantation due to blood or marrow involvement or failure to mobilize autologous stem cells or are not considered eligible for autologous transplant by their treating physician * Hodgkin’s lymphoma: relapse after autologous hematopoietic cell transplant (HCT), chemorefractory disease * Multiple myeloma: per National Comprehensive Cancer Network (NCCN) guidelines
• No suitable human leukocyte antigen (HLA)-identical sibling donor
• No identified 8/8 (based upon A, B, C, DRB1 loci) allele matched unrelated donor, or unable to wait sufficient time to procure an 8/8 allele matched unrelated donor
• Available HLA 3-5/6 matched genotypically haploidentical family member donor (based upon A, B intermediate and DRB1 high resolution HLA typing; additional C and DQB1 typing may be necessary to accurately assign haplotypes)
• Female subjects must be surgically sterile, postmenopausal (minimum 1 year without menses), or agree to use one or more of the following forms of contraception from the time of signing the informed consent form through day +100: hormonal (i.e., oral, transdermal, implant, or injection); double barrier (i.e., condom, diaphragm with spermicide); intrauterine device (IUD); vasectomized partner (six months minimum); or abstinence; male subjects must also agree to use one or more of the above forms of birth control for either themselves or their partner, as appropriate, from the time of signing the informed consent form through day +100
• Able to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelines
• DONOR: blood relative of the subject
• DONOR: half match (haploidentical) at HLA-A, B, C, DRB1 based upon deoxyribonucleic acid (DNA) based typing methods; donors may be variably matched for the other allele (4/8 to 7/8), but not fully matched
• DONOR: must be capable of and consent or assent to donation of peripheral blood stem cells
• DONOR: must have adequate peripheral venous access for leukapheresis or must agree to placement of a temporary central venous catheter
• DONOR: meet criteria for related donor including infectious disease testing and history and physical exam and receive clearance by transplant physician per University of Utah standard operating procedure (SOP)
• DONOR: weight of at least 35 kg
• DONOR: age >= 12 and =< 75 years
• DONOR: female and male donors must agree to use one or more forms of birth control for either themselves or their partner, as appropriate, from the time of signing the informed consent form through day +6: hormonal (i.e., oral, transdermal, implant, or injection); double barrier (i.e., condom, diaphragm with spermicide); intrauterine device (IUD); vasectomized partner (six months minimum); or abstinence

Exclusion Criteria

• Available HLA identical matched sibling donor (unless having failed a prior allogeneic transplant from an HLA identical matched sibling)
• Recipient HLA antibodies against donor HLA
• Left ventricular ejection fraction < 40%, symptomatic coronary artery disease, or uncontrolled arrhythmias
• Forced expiratory volume in one second (FEV1) or diffusing capacity of the lung for carbon monoxide (DLCO) < 40% or need for use of supplemental oxygen
• Calculated or measured glomerular filtration rate (GFR) < 30 ml/min, dialysis requirement, or prior renal transplant
• Bilirubin > 2.0
• Alanine aminotransferase (ALT) > 2.5 X upper limit of normal (ULN)
• Cirrhosis
• Subjects with active or uncontrolled bacterial, viral, or fungal infections requiring systemic therapy
• Subjects who have tested positive for human immunodeficiency virus (HIV)
• Pregnant women, nursing mothers or women of child-bearing potential who are unwilling to use medically accepted methods of contraception
• DONOR: females who are pregnant (positive serum beta-human chorionic gonadotropin [B-HCG]) or uninterruptible breastfeeding
• DONOR: known allergy to granulocyte colony-stimulating factor (G-CSF) or to Escherichia Coli (E. Coli)-derived recombinant protein products