Clinical trial NCT02094794 (phase 2, status: recruiting)
Conditions: 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(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), recurrent adult acute lymphoblastic leukemia, recurrent adult acute myeloid leukemia, recurrent childhood acute lymphoblastic leukemia, recurrent childhood acute myeloid leukemia
ICD codes: R19.5, H35.09, M26.50, M26.59, Q99.8, R06.89, R06.9, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C83.57, C83.50, C91.01, C91.02, C83.52, C83.56, C83.53, G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2, C83.57, C83.50, C91.01, C91.02, C83.52, C83.56, C83.53, G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2
Drugs: etoposide, cyclophosphamide
SMILES: OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1, ClCCN(CCCl)P1(=O)NCCCO1
Eligibility criteria:

        Inclusion Criteria:

          -  Participant has the ability and the willingness to sign the informed consent document
             (for adults only, for participants with mild cognitive abilities may use a legally
             authorized representative)

          -  Documented (signed) informed consent; the patient, family member and transplant staff
             physician (physician, nurse, and social worker) meet at least once prior to starting
             the transplant procedure; during this meeting all pertinent information with respect
             to risks and benefits to donor and recipient will be presented; alternative treatment
             modalities will be discussed; the risks are explained in detail in the enclosed
             consent forms

          -  Karnofsky performance status >= 70% =< 2

          -  Acute lymphocytic leukemia or acute myelogenous leukemia who are not in first
             remission or second remission i.e. after failing induction therapy, or in relapse or
             beyond second remission; (prior therapy with VP-16 and Cytoxan is allowed)

          -  All candidates for this study must have a human leukocyte antigen (HLA) (A, B, C, DR)
             identical siblings who is willing to donate bone marrow or primed blood stem cells or
             a 10/10 allele matched unrelated donor; a single allele mismatch at A, B, C, DR or DQ
             and a killer immunoglobulin-like receptor (KIR) mismatch at C will be allowed; all ABO
             blood group combinations of the donor/recipient are acceptable

          -  The time from the end last induction, re-induction, or consolidation regimen should be
             greater than or equal to 14 days from planned start of study treatment; Note:
             Chemotherapy given within 14 days of planned study enrollment for the purpose of
             controlling counts is permitted

          -  Total bilirubin =< 1.5 x upper limit of normal (ULN) OR 3 x ULN for Gilbert's disease

          -  Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate
             transaminase (SGPT) =< 5 x ULN

          -  Measured creatinine clearance >= 80 ml/min per 24 hour urine collection OR serum
             creatinine =< 1.3 mg/dL

          -  Women of child bearing potential only: Negative urine or serum pregnancy test

          -  Pulmonary function tests: Forced expiratory volume in one second (FEV1) and carbon
             monoxide diffusion capacity (DLCO) (adjusted for Hb) >= 50% adjusted of predicted
             normal value

          -  Echocardiogram (ECHO) or multi gated acquisition scan (MUGA): ejection fraction of >=
             50% AND no finding of abnormal wall motion (i.e. report does not indicate that wall
             motion is "abnormal" or "altered")

          -  Electrocardiogram (EKG) showing no ischemic changes and no abnormal rhythm

          -  Agreement of men AND women-of-child-bearing-potential to use adequate contraception
             (hormonal or barrier method of birth control or abstinence) prior to study entry and
             for six months following duration of study participation; should a woman become
             pregnant or suspect that she is pregnant while participating on the trial, she should
             inform her treating physician immediately

          -  DONOR ELIGIBILITY: Donor evaluation and eligibility will be assessed as per current
             City of Hope standard operating procedure (SOP)

        Exclusion Criteria:

          -  Prior autologous or allogeneic hematopoietic stem cell

          -  Prior radiation therapy that would exclude the use of TMLI

          -  Plans during the trial to receive any other (non-trial) investigational agents, or
             concurrent biological, chemotherapy, or radiation therapy; (chemotherapy for white
             blood count control is permitted)

          -  Uncontrolled illness including ongoing or active infection

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to etoposide

          -  Patients with other active malignancies are ineligible for this study, other than
             localized malignancies

          -  Patients with psychological or medical condition that patient's physician deems
             unacceptable to proceed to allogeneic hematopoietic stem cell transplantation

          -  Women who are planning to become pregnant or breast feed during the trial

          -  Subjects, who in the opinion of the investigator, may not be able to comply with the
             safety monitoring requirements of the study