Clareo Health | Expanded Cord Blood Cell Infusion Following Combination Chemotherapy in Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Nohla Therapeutics, Inc.
With
National Cancer Institute (NCI)
Fred Hutchinson Cancer Center
Age
0–30
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
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
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
Adequate cardiac, renal, pulmonary, and hepatic function
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
You may not be if
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
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
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
