Clinical Trial Detail

This pilot clinical trial studies infusion of laboratory-grown donor cord blood cells following combination chemotherapy in treating younger patients with relapsed or refractory acute myeloid leukemia. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemotherapy also kills healthy infection-fighting cells, increasing the risk of infection. The infusion of laboratory-grown cord blood cells may be able to replace blood-forming cells that were destroyed by chemotherapy. This may decrease the risk of infection following chemotherapy, and allow for more chemotherapy to be given so that more cancer cells are killed.

Ages Eligible for Study: 2 Years to 30 Years

Genders Eligible for Study: Both

- Patients must have a diagnosis of AML according to World Health Organization (WHO) classification with >= 5% of disease in bone marrow (BM), with or without extramedullary disease or biopsy-proven isolated myeloid sarcoma (myeloblastoma, chloroma, including leukemia cutis) in the absence of marrow involvement

- AML:

-- If relapse AML:

---- i) Must have a prior diagnosis of AML and be in 1st or greater relapse

---- ii) Must not have received prior reinduction therapy for this relapse

-- If primary refractory AML:

---- i) Must have had a prior diagnosis of AML and

---- ii) Must not have received more than 3 previous induction attempts

- Patients must be classified as central nervous system (CNS)1 or CNS 2 and without clinical signs of CNS leukemia such as cranial nerve palsy; patients with CNS 3 disease are not eligible

- Must have a Lansky or Karnofsky performance status of >= 50; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age

- Patients must have recovered from the acute toxicity of all prior chemotherapy; patients may not have received cytotoxic chemotherapy within 2 weeks of first dose of G-CSF (filgrastim) therapy, with exception of hydroxyurea, which is allowed for up to 24 hours prior to first dose of G-CSF, and intrathecal chemotherapy, which is allowed prior to, or in the 1st 72 hours after start of G-CSF therapy

- The following amounts of time must have elapsed prior to entry on study:

--- 2 weeks from local radiation therapy (XRT)

--- 8 weeks from prior craniospinal or if > 50% of the pelvis has been irradiated

--- 6 weeks must have elapsed if other bone marrow radiation has occurred

- Creatinine within normal range for age (per institutional defined lab value ranges)

- Direct bilirubin =< 1.5 upper limit of normal (ULN) age unless elevation thought to be due or hepatic infiltration by the hematologic malignancy

- Alanine aminotransferase (ALT) < 5 x ULN age

- Adequate cardiac function as defined as shortening fraction of > 27% OR ejection fraction of > 50%

- Patients must have a calculated QT (QTc) interval < 450 ms on baseline echocardiogram

- Patients must demonstrate a respiratory rate that is within normal limits for age, measured when afebrile and at rest (measured for a full minute) and pulse oximetry > 93% on room air

- Signed informed consent

- Patient must have a life expectancy of at least 2 months

- Females of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment

- Females of childbearing potential and males should agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation

Other eligibility criteria may apply.

- Recipient of prior allogeneic hematopoietic stem cell transplant (HCT)

- Patients with history of Down's syndrome, Fanconi anemia or other known marrow failure condition

- Patients with central nervous system (CNS) 3 disease or symptomatic CNS2 disease are not eligible

- Patients currently receiving other investigational drugs are not eligible

- Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol with the exception of intrathecal chemotherapy; this includes the tyrosine kinase inhibitor sorafenib which must not be initiated until patient demonstrates count recovery

- Patients with a systemic fungal, bacterial, viral, or other infection not controlled despite appropriate antibiotics or other treatment; uncontrolled systemic infections require infectious disease consultation for verification

- Patients who are platelet refractory prior to initiation of protocol therapy; platelet refractoriness is defined by platelet count < 50K when platelet count is obtained 1 hour post platelet transfusion

- Pregnant or lactating patients

- Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results

Other exclusion criteria may apply.