Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
New York Medical College
Age
0–30
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age ≤30.99 years old
Disease Status (Part A - Safety Phase)
ALL in 1st, 2nd or 3rd relapse OR primary induction failure.
AML in 1st ,2nd or 3rd relapse OR primary induction failure.
T-or B -- Lymphoblastic Lymphoma (T-LBL, B-LBL); Diffuse Large B-cell Lymphoma (DLBCL) or Burkitt Lymphoma/Leukemia in 1st, 2nd or 3rd relapse OR primary induction failure.
5.1.2.2 (Part B - Efficacy Phase)
ALL in 2nd or 3rd relapse OR primary induction failure.
AML in 2nd or 3rd relapse OR primary induction failure.
T-or B -- Lymphoblastic Lymphoma (T-LBL, B-LBL); Diffuse Large B-cell Lymphoma (DLBCL) or Burkitt Lymphoma/Leukemia in 1st, 2nd or 3rd relapse OR primary induction failure.
Adequate renal function defined as:
\- Normal Serum creatinine based on age or Creatinine clearance \> 60 ml/min or \>60 ml/min/1.73 m2 or an equivalent radioisotope glomerular filtration rate (GFR) as determined by the institutional normal range.
Adequate liver function defined as:
Direct bilirubin \< 1.5 upper limit of normal (ULN) for age, and SGOT (AST) or SGPT (ALT) \<3 x ULN
Adequate cardiac function defined as:
Shortening fraction \>27% by echocardiogram, or
Ejection fraction of \>50% by radionuclide angiogram or echocardiogram.
Performance Status
For patients age 1-16 years, Lansky score of ≥60.
For patients \> 16 years, Karnofsky score of ≥60.
Negative urine pregnancy test for females of child bearing age.
Table 1. Anthracycline Conversion Agent Conversion Factor to Doxorubicin Dose Doxorubicin Multiply total dose x 1 Daunorubicin Multiply total dose x 0.833 Idarubicin Multiply total dose x 5 Mitoxantrone Multiply total dose x 4
Informed Consent
\- Patients or the patient's legally authorized guardian must be fully informed about their illness and the investigational nature of this protocol (including foreseeable risks and possible side effects), and must sign an informed consent in accordance with the institutional policies approved by the U.S. Department of Health and Human Services.
You may not be if
Patients with prior myeloablative allogeneic stem cell transplantation \<3 months prior to proposed enrollment on study and/or ≥Grade II active acute GVHD or extensive chronic GVHD.
Females who are pregnant (positive HCG) or lactating.
Karnofsky \<60% or Lansky \<60% if less than 16 years of age.
Age \>30.99 years of age.
Patients with active CNS disease.
Any patient with uncontrolled infection prior to study entry.
