Substantive changes to the Protocol are detailed below:
 

CHAPTER 2 – STUDY DESIGN

• Section 2.2.1 Eligibility Criteria - Closed accrual for AML and ALL patients with greater than 3rd medullary relapse or refractory disease, patients in blast crisis, and infant leukemia patients. Clarified HLA match criteria for patients enrolling with 3 of 6 match.
• Section 2.2.2 Exclusion Criteria - Clarified criteria for immune deficiency patients.
• Section 2.3.2 Stratification Variables - Identified strata closed to accrual.
• Section 2.4 Treatment Plan - Closed accrual to patients with Fanconi Anemia, inborn errors of metabolism and storage disease, and patients with malignant diseases.
• Section 2.4.6.2 Busulfan Dose Adjustment - Clarified target concentration levels.
• Section 2.5.2 Required Observations - Revised required observation for pre-transplant collection of peripheral blood for chimerism studies.
• Section 2.7 Off-Study Cord Blood Transplants - Added requirement of IRB-approval for EAP and other alternative cord blood transplant protocol. Clarified identification of patients considered to be on the EAP.

APPENDIX A - SAMPLE INFORMED CONSENTS - Information was added describing radiation procedures for male ALL patients, unexpected side effects and treatment risks, right to refuse or withdraw from study, financial costs, and previous COBLT experience for high risk adult patients.