GVHD Prophylaxis With Post Transplant Cyclophosphamide for Patients With Renal Insufficiency Undergoing a Conventional 8/8 HLA-matched Related or Unrelated Donor Allogeneic Hematopoietic Stem Cell Transplant
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Memorial Sloan Kettering Cancer Center
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Age: Patients over age 18 who are deemed eligible for transplant by their treating physician.
Disease status:
1. AML in ≥ 1st remission - excluding those in 1st remission with 'good risk' cytogenetic features (i.e. t(8;21), t(15;17), inv 16).
2. Secondary AML
3. ALL/LL in 1st remission with clinical or molecular features indicating a high risk for relapse; or ALL \> 2nd remission
4. CML failing to respond to, progressing on or not tolerating appropriate TKI therapy in first chronic phase of disease; CML in accelerated phase, second chronic phase, or in CR after accelerated phase or blast crisis.
5. Non-Hodgkins lymphoma with chemoresponsive disease in any of the following categories:
1. high grade lymphomas who have failed to achieve a first CR or have relapsed following a 1st remission who are not candidates for autologous transplants or transplants requiring the use of calcineurin inhibitors.
You may not be if
7. Chronic myelomonocytic leukemia: CMML-1 and CMML-2, advanced polycythemia vera, and myelofibrosis.
1. Patients must have a healthy HLA compatible (8/8 molecularly matched related, or unrelated) donor willing to undergo BM harvesting or PBSC apheresis after G-CSF administration. BM will be the preferred graft source.
2. Patients diagnosed with any form of acute leukemia must have received induction and at least one course of consolidation chemotherapy pretransplant
Patients must have a Karnofsky Performance Status \> 70%
Patients will have a eGFR \<60 ml/min/1.73 m2
1. Patients must have adequate organ function measured by: Cardiac: asymptomatic or if symptomatic then LVEF at rest must be \> 50% and must improve with exercise.
2. Hepatic: ALT \< 3 x ULN and total serum bilirubin \< 1.5 x ULN, unless there is congenital benign hyperbilirubinemia
3. Renal: eGFR \> 30 ml/min/1.73 m2
4. Pulmonary: asymptomatic or if symptomatic, DLCO \> 50% of predicted (corrected for hemoglobin)
Each patient must be willing to participate as a research subject and must sign an informed consent form.
Patient must have a fully matched related or unrelated donor willing to donate stem cells.
Major surgery or irradiation within two weeks.
Active CNS or extramedullary malignant disease.
Active and uncontrolled infection at time of transplantation including active infection with Aspergillus or other mold, or HIV infection
Pregnant or lactating women - they are excluded, given the potential teratogenic effects of chemotherapy and agents used in the transplant.
Male and female patients of child-bearing potential unwilling to use effective means of contraception
HIV or HTLV I/II positive, hepatitis C or chronic active hepatitis B.
Patients who have had a previous malignancy unless they are deemed by their treating physicians to be at low risk for recurrence.
Patient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up and research tests.
Clareo Health | GVHD Prophylaxis With Post Transplant Cyclophosphamide for Patients With Renal Insufficiency Undergoing a Conventional 8/8 HLA-matched Related or Unrelated Donor Allogeneic Hematopoietic Stem Cell Transplant
