Haplo Peripheral Blood Sct In GVHD Prevention

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

Conditions

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

Sponsors & Collaborators

• Regimmune Corporation

  collaborator INDUSTRY

• Zachariah Michael DeFilipp

  lead OTHER

Principal Investigators

• Zachariah DeFilipp, MD · Massachusetts General Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-14

Primary Completion

2023-10-22

Completion

2024-08-19

FDA Drug

Yes

Countries

• United States

Study Locations