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Laboratory-Treated Donor Cord Blood Cell Infusion Following Combination Chemotherapy in Treating Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia

Complete title: Pilot Study Evaluating the Use of Ex Vivo Expanded Cord Blood Progenitors as Supportive Care Following Chemotherapy (FLAG) in Patients with AML or Acute Leukemia of Ambiguous Lineage

Research Study Number       2584.00
Principal Investigator       Ann Dahlberg
Phase       Pilot

Look up trial at NIH

Research Study Description

This pilot clinical trial studies infusion of laboratory-grown donor cord blood cells following combination chemotherapy in treating younger patients with acute myeloid leukemia that has returned or that does not respond to treatment. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. 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.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 6 Months to 30 Years

Genders Eligible for Study: Both

- Patients must have a diagnosis of AML or acute leukemia of ambiguous lineage according to World Health Organization (WHO) classification with >= 5% of disease in bone marrow (BM); patients with blast count < 5% are eligible if immunophenotype, molecular or cytogenetic signature are consistent with AML as determined by primary treating oncologist; patients with extramedullary disease, or biopsy-proven isolated myeloid sarcoma (myeloblastoma, chloroma, including leukemia cutis) are eligible regardless of marrow involvement

- AML or acute leukemia of ambiguous lineage:

-- * If relapse AML or acute leukemia of ambiguous lineage:

--- ** Must have a prior diagnosis of AML or acute leukemia of ambiguous lineage and be in 1st or greater relapse as evidenced by morphology, immunophenotype, molecular or cytogenetic signature

--- ** Must not have received prior reinduction therapy for this relapse

-- * If primary refractory AML or acute leukemia of ambiguous lineage:

--- ** Must have had a prior diagnosis of AML or acute leukemia of ambiguous lineage and

--- ** Must not have received more than 3 previous induction attempts

-- * If primary AML or acute leukemia of ambiguous lineage newly diagnosed or in remission

--- ** Primary treating oncologist must have deemed patient unable to complete standard treatment therapy and selected FLAG as appropriate alternative regimen

-- * If prior diagnosis of acute lymphoblastic leukemia must have evidence of transformation to AML or acute leukemia of ambiguous lineage as evidenced by morphology, immunophenotype, molecular or cytogenetic signature

-- * Patients meeting above criteria are eligible regardless of central nervous system (CNS) classification

- Recipients of prior allogeneic hematopoietic stem cell transplantation for AML or acute leukemia of ambiguous lineage are eligible if they do not have graft-versus-host disease (GVHD) or they have quiescent GVHD whether or not they are receiving immunosuppressive therapy

- 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 corrected QT (QTc) interval < 450 ms on baseline electrocardiogram (EKG)

- 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.

Exclusions (conditions that would prevent participation in this study)

- Recipients of prior allogeneic hematopoietic stem cell transplant (HSCT) with active acute or chronic GVHD

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

- 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 < 50 K 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.

Research Study Number       2584.00
Contact       Seattle Cancer Care Alliance Intake Office
Telephone       800-804-8824 / 206-288-1024

Leukemia, Acute Myeloid (AML); Hematologic Malignancies; Leukemia; Leukemia, Myeloid; Leukemia, Prolymphocytic

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Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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