Haplo Peripheral Blood Sct In GVHD Prevention

Acute Myeloid Leukemia Clinical Trial

Official title: Reduced Intensity Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Sirolimus/Mycophenolate Mofetil/RGI-2001 Based GVHD Prevention: a Pilot Study

Status Active, not recruiting

Clinical Trial Summary

This research study is studying the RGI-2001 for preventing Graft-vs-Host Disease (GVHD) in people with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS), myeloproliferative disorders (MPN), chronic myelomonocytic leukemic (CMML), chemosensitive hodgkin lymphoma (HL), or Non-Hodgkin lymphoma (NHL).who will have a blood stem cell transplantation.

• GVHD is a condition in which cells from the donor's tissue attack the organs.

• RGI-2001 is an investigational treatment

Clinical Trial Description

• This is a pilot study in subjects undergoing reduced-intensity haploidentical peripheral blood stem cell transplantation who will receive graft-versus-host disease prevention with post-transplant cyclophosphamide, followed by sirolimus, mycophenolate mofetil, and RGI-2001.

• The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

• The standard of care drugs of fludarabine, cyclophosphamide, melphalan, radiation, sirolimus, and mycophenolate mofetil are all FDA approved.

• Eligible Participants will be placed in 1 of 2 groups, per physicians discretion:

• Regimen #1 :

• Before stem cell transplant:Fludarabine + Cyclophosphamide + Radiation

• After stem cell transplant: Cyclophosphamide + Sirolimus +Mycophenolate mofetil + RGI-2001

• Regimen #2

• Before stem cell transplant: fludarabine + melphalan + radiation

• After stem cell transplant: cyclophosphamide + sirolimus +Mycophenolate mofetil + RGI-2001

• A total of 20 participants will be enrolled to this trial

• The U.S. Food and Drug Administration (FDA) has not approved RGI-2001 as a treatment for any disease. ;

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• ALL
• AML
• Blood Stem Cell Transplant Failure
• Chemosensitive Hodgkin Lymphoma
• Chronic Myelomonocytic Leukemia
• CMML
• Graft Vs Host Disease
• GVHD
• Hodgkin Disease
• Hodgkin Lymphoma
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Leukemia, Myelomonocytic, Chronic
• Leukemia, Myelomonocytic, Juvenile
• Lymphoma
• Lymphoma, Non-Hodgkin
• MDS
• MPN
• Myelodysplastic Syndromes
• Myeloproliferative Disorder
• Myeloproliferative Disorders
• Non Hodgkin Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Preleukemia

• NCT number: NCT04473911
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: August 14, 2020
• Completion date: October 2024