Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2025-12-24 @ 5:04 PM
NCT ID:
NCT00809250
Eligibility Criteria:
Inclusion Criteria:
* Patients who have received an allogeneic bone marrow or peripheral blood stem cell transplant for AML, meeting one of the following: 1) AML arising from MDS or MDP 2)AML CR1 associated with high risk cytogenetics 3) AML transplanted in induction failure or relapse 4) AML transplanted in second remission or beyond 5) AML in patient 60 years or older
* Patients who have received an allogeneic bone marrow or peripheral blood stem cell transplant for MDS-RAEB or CMML
* 18 years of age or older
* Donor is a related or unrelated donor who is at least 9/10 matched at HLA-A, B, C, DRB1, and DQB1 by antigen level typing at class 1 and allele level typing at class II
* Recipients of myeloablative or reduced intensity conditioning transplants are eligible
* Patient must have sufficient autologous tumor cells banked at DFCI (on companion tissue banking protocol) for vaccine generation prior to transplantation
* No active GVHD requiring systemic corticosteroid therapy
* No conditions requiring systemic corticosteroid therapy greater than or equal to 20mg methylprednisolone or equivalent
* No uncontrolled infection
* Adequate hematopoietic engraftment with ANC \>500 off growth factor support, and platelet \>10k without transfusion
* No non-hematologic toxicity of CTC Grade 3 or greater
* ECOG Performance Status 0-2
Exclusion Criteria:
* Recipients of cord blood transplant
* Patients with uncontrolled CNS disease
* Patients with relapsed/persistent disease after transplant who are expected to require rapid withdrawal of immune suppression, cytoreductive therapy, or have a life expectancy of \< 3 months
* Concurrent participation in other transplant clinical trials where GVHD and/or disease relapse are primary endpoints
* Patients deemed medically or psychologically unfit by treating physician or study investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00809250
Study Brief:
Protocol Section:
NCT00809250