This is a pilot study which will be done in a small number of patients. The purpose of this
study is to test the safety and benefit of giving a type of chemotherapy - cyclophosphamide -
after the transplant to prevent graft versus host disease (GVHD) in patients with abnormal
kidney function. GVHD is one of the most common complications of a stem cell transplant .
- Age: Patients over age 18 who are deemed eligible for transplant by their treating
- 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
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.
2. any NHL with therapy responsive disease which is considered not curable
outside the transplant setting and not eligible/appropriate for autologous
transplant or a higher priority protocol.
6. Myelodysplastic syndrome (MDS): RA/RCMD with high risk cytogenetic features or
transfusion dependence, RAEB-1 and RAEB-2 and AML evolved from MDS, who are not
eligible for a higher priority protocol.
7. Chronic myelomonocytic leukemia: CMML-1 and CMML-2, advanced polycythemia vera,
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
- 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
- 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
- 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
- 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