T-Cell Depleted Double UCB for Refractory AML (NCT01464359) | Clinical Trial Compass
TerminatedPhase 2
T-Cell Depleted Double UCB for Refractory AML
Stopped: Slow accrual
United States3 participantsStarted 2011-10
Plain-language summary
This trial is proposes to build on our experience and is designed to maximize early (day 3-14) and late (day 60-71) donor-derived natural killer (NK) cell expansion and function in vivo. The proposed platform will allow us the unique opportunity to compare in vivo function from a transplanted umbilical cord blood (UCB) source (presumed to contain NK progenitors requiring "education" in the recipient).
Who can participate
Age range2 Years – 45 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 2 to 45 years with acute myeloid leukemia (AML) who meet one of the following criteria:
* Primary induction failure defined as no complete remission (CR) after two or three induction cycles (no blast limit).
* Relapsed AML with low disease burden: For patients \>21 through 45 years of age: must have \<30% marrow blasts within 14 days of enrollment and be at least 28 days from the start of last therapy. For patients 2 through ≤ 21 years of age: must have \>5% marrow blasts after no more than 3 induction attempts.
Patients with prior central nervous system (CNS) involvement are eligible provided that it has been treated and is in remission. CNS therapy (chemotherapy or radiation) should continue as medically indicated during the protocol.
* Have acceptable organ function within 14 days of study registration defined as:
* Renal: creatinine ≤ 2.0 mg/dL (adult patients) or calculated creatinine clearance \> 40 ml/min (pediatric patients)
* Hepatic: bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) ≤ 5 times upper limit of normal
* Pulmonary function: diffusing lung capacity for carbon monoxide corrected for hemoglobin (DLCOcorr) \> 50% of normal, (oxygen saturation \[\>92%\] can be used in child where pulmonary function tests (PFT's) cannot be obtained)
* Cardiac: left ventricular ejection fraction ≥ 45%
* Karnofsky Performance Status ≥ 70% (≥ 16 years) or Lansky Play Score ≥ 50 (pedi…
What they're measuring
1
Disease Free Survival
Timeframe: At 3 months
Trial details
NCT IDNCT01464359
SponsorMasonic Cancer Center, University of Minnesota