Haplo Peripheral Blood Sct In GVHD Prevention

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

August 14, 2020

Primary Completion Date

October 22, 2023

Study Completion Date

August 19, 2024

Conditions
GVHDAMLALLMDSMPNCMMLHodgkin LymphomaNon Hodgkin LymphomaBlood Stem Cell Transplant FailureGraft Vs Host DiseaseAcute Myeloid LeukemiaAcute Lymphoblastic LeukemiaMyelodysplastic SyndromesMyeloproliferative DisorderChronic Myelomonocytic LeukemiaChemosensitive Hodgkin Lymphoma
Interventions
DRUG

FLUDARABINE

predetermined dose, intravenously, a predetermined times per cycle Given in both pre stem cell and post stem cell cycles

DRUG

CYCLOPHOSPHAMIDE

◦Cyclophosphamide predetermined dose, predetermined number of times in Given in pre-stem cell Regimen #1 Cyclophosphamide predetermined dose, predetermined number of times in cycle, intravenous infusion

RADIATION

TBI

Total body irradiation (TBI) once per cycle.

DRUG

Melphalan

Melphalan, infusion, determined dosage, once per cycle

DRUG

Sirolimus

Sirolimus: Predetermined dosage, predetermined number of time in cycle, oral: Please note that doses of sirolimus can be adjusted at the treating physician's discretion given the multiple drugs and other situations which affect its metabolism

DRUG

Mycophenolate mofetil

◦Mycophenolate mofetil, oral or iv(predetermined dose or IV TID (based upon actual body weight), at predetermined times per cycle

DRUG

RGI-2001

IV, predetermined dose, weekly to 6 total doses

DRUG

CYCLOPHOSPHAMIDE

◦Given in Post Stem Cell cycle of Regimen #1 and #2 Cyclophosphamide predetermined dose, predetermined number of times in cycle, intravenous infusion

Trial Locations (1)

02115

Massachusetts General Hospital, Boston

All Listed Sponsors
collaborator

Regimmune Corporation

INDUSTRY

lead

Zachariah Michael DeFilipp

OTHER

NCT04473911 - Haplo Peripheral Blood Sct In GVHD Prevention | Biotech Hunter | Biotech Hunter