Hematopoietic Cell Transplantation/HCT involves receiving healthy blood-forming cells (stem cells) from a donor to replace the diseased or damaged cells in participants' bone marrow. The researchers think giving participants treatment with fludarabine and dexamethasone, drugs that lower the activity of the body's immune system (immune suppression), before standard conditioning therapy and HCT may help prevent serious side effects, including graft failure and GvHD. In this study, depending on how participants' body responds to the fludarabine and dexamethasone, the study doctor may decide participants should receive another drug, called cyclophosphamide, instead of fludarabine. In addition, depending on the results of participants' routine blood tests, participants may receive the drugs bortezomib and rituximab, which also help with immune suppression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
PK-guided fludarabine dosing will be used for each of the 2 cycles, using the InsightRx DoseMeRx platform.
Cyclophosphamide will be administered Post-Transplant
Tacrolimus will be administered beginning on day +5
Mycophenolate mofetil (MMF) will be administered three times daily starting on day +5.
The dose and schedule of ATG will be determined according to the nomogram in Appendix A
Standard Regimen: Dexamethasone on days -68 to -64 and days -40 to -36.
Bortezomib on days -71, -68, -65, -61, -43, -40, -37, and -33
Rituximab on days -71, -58, -43, and -30.
Memorial Sloan Kettering at Basking Ridge (Consent only)
Basking Ridge, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Bergen (Consent only)
Montvale, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Suffolk - Commack (Consent only)
Commack, New York, United States
RECRUITINGMemorial Sloan Kettering Westchester (Consent only)
Harrison, New York, United States
RECRUITINGMemorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, United States
RECRUITINGNumber of participants with treatment related mortality/TRM or primary graft failure
The primary outcome is to estimate treatment-related mortality (TRM) or primary graft failure at 1 year post-HCT.
Time frame: 1 year
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