AML Clinical Trial
Official title:
Safety and Tolerability Trial of Abatacept-based Immunosuppression for Prevention of Acute GvHD During Unrelated Donor Hematopoietic Stem Cell Transplant
Verified date | October 2019 |
Source | Boston Children’s Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of the study is to determine the safety and tolerability when adding abatacept to acute Graft versus Host Disease in transplants for malignant diseases using unrelated donor bone marrow or peripheral blood stem cell grafts.
Status | Completed |
Enrollment | 11 |
Est. completion date | January 2013 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients with AML, with or without a history of myelodysplastic syndrome in one of the following categories. (a) Patients in first complete remission with high-risk features 2. Patients with ALL, in either of the following categories: 1. In 2nd or greater complete remission (complete remission is defined as > 5% blasts in marrow) 2. Delayed 1st CR-Failure to achieve complete remission after a single round of induction therapy 3. Patients with undifferentiated or biphenotypic leukemia in 1st or greater complete remission. 4. Patients with Myelodysplastic Syndrome(s) with an IPSS score of >1.5 and <10% blasts in the bone marrow at the time of transplant. These conditions will include: 1. Refractory anemia 2. Refractory anemia with ringed sideroblasts 3. Refractory cytopenia with multilineage dysplasia 4. Refractory cytopenia with multilineage dysplasia and ringed sideroblasts 5. Refractory anemia with excess blasts-1 (5-10% blasts) 6. Refractory anemia with excess blasts-2 (10-20% blasts) 7. Myelodysplastic syndrome, unclassified 8. MDS associated with isolated del (5q) 9. Patients diagnosed with AML in CR1 after an initial diagnosis of MDS. 5. Age 12 years or older. 6. No prior allogeneic transplant 7. Karnofsky performance score or Lansky Play-Performance of at least 80. 8. Signed informed consent for adults and for minors the provision of pediatric assent and parental permission. Exclusion Criteria: 1. Age <12 years old. 2. Patients requiring >2 courses of induction chemotherapy to achieve remission status. 3. HIV infection 4. Tuberculosis Infection 5. Chronic Obstructive Pulmonary Disease 6. Pregnancy (positive serum b-HCG) or breastfeeding 7. Creatinine clearance or nuclear medicine GFR of < 50 mL/min 8. Cardiac ejection fraction < 50% 9. bilirubin > 2 × upper limit of normal or ALT > 4 × upper limit of normal or unresolved veno-occlusive disease. 10. Pulmonary disease with FVC, FEV1 or DLCO parameters <45% predicted (corrected for hemoglobin) or O2 saturation <92% on room air. 11. Karnofsky performance score or Lansky Play-Performance Scale <80 12. Uncontrolled viral, bacterial, or fungal infection at the time of study enrollment 13. Availability of a willing and fully MHC-matched related donor. 14. Positive cytotoxic recipient-donor cross-match or positive HLA antibody screen against donor-disparate antigens. 15. Any active infection. 16. Unable to obtain informed consent. |
Country | Name | City | State |
---|---|---|---|
United States | Boston Children's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Children’s Hospital |
United States,
Koura DT, Horan JT, Langston AA, Qayed M, Mehta A, Khoury HJ, Harvey RD, Suessmuth Y, Couture C, Carr J, Grizzle A, Johnson HR, Cheeseman JA, Conger JA, Robertson J, Stempora L, Johnson BE, Garrett A, Kirk AD, Larsen CP, Waller EK, Kean LS. In vivo T cell — View Citation
Suessmuth Y, Mukherjee R, Watkins B, Koura DT, Finstermeier K, Desmarais C, Stempora L, Horan JT, Langston A, Qayed M, Khoury HJ, Grizzle A, Cheeseman JA, Conger JA, Robertson J, Garrett A, Kirk AD, Waller EK, Blazar BR, Mehta AK, Robins HS, Kean LS. CMV — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With Grade III-IV Acute GVHD by Day 100. | Grade III-IV Acute GVHD by Day 100. The incidence of Gr III-IV acute GVHD was measured by the modified Glucksburg scale. | Day 100 post-transplant | |
Secondary | Percentage of Participants With Grades III-IV Acute GVHD at 2 Years | The rates of Grades III-IV acute GVHD were measured at 2 years according to standard Glucksberg criteria, which was 10%. | 2 years after transplant | |
Secondary | Hematologic and Immunologic Reconstitution | Flow cytometric analysis of CD4 t-cell t-cell reconstitution was performed at day +100 post-transplant. | Day +100 post-transplant | |
Secondary | Protective Immunity | Percent of CMV virus binding CD8+ t-cells at day +365 post-transplant | Day +365 post-transplant |
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