MedTrace Logo

Intravenous Administration of RGI-2001 in Patient Undergoing Allogenic Hematopoietic Stem Cell Transplantation (AHSCT)

NCT01379209 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2019-10-23

No results posted yet for this study

Summary

The clinical trial is a Phase 1/2a, open-label, multi-center, dose-escalation study to evaluate the safety, tolerability and pharmacokinetic profile of RGI-2001 in patients undergoing AHSCT, with radiation or non-radiation myeloablative preparative treatment.

The study will be separated into two parts; a dose escalation phase to assess safety, followed by a large expansion phase to further evaluate the pharmacologic effects of either a Maximum Tolerated Dose, Maximum Feasible Dose or optimal pharmacologically active dose of RGI-2001. The initial dose escalation safety portion of the study (Part 1) will include higher risk patients and limit the unrelated donor transplants. After safety is established in part 1 of the study, the second portion of the study will expand the enrollment criteria and allow transplantation by either related or unrelated donors.

This study will endeavor to identify the dose range at which RGI-2001 has an acceptable safety profile, at which biologic activity is observed, and to guide possible dose levels to utilize in later phase studies based on biological activity.

Conditions

Interventions

DRUG

RGI-2001

A single administration of RGI-2001 on Day 0 post AHSCT.

DRUG

Calcineurin Inhibitors

GVHD prophylaxis according to institutional guidelines. Subjects could have received any number/combinations of treatments.

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

According to institutional guidelines.

DRUG

Conditioning Regimen

Myeloablative preparative treatment according to institutional guidelines. Subjects could have received any number/combinations of treatments.

PROCEDURE

Allogeneic Bone Marrow Transplantation

According to institutional guidelines

DRUG

Methotrexate

DRUG

Mofetil Mycophenolate

DRUG

sirolimus

Administered for GVHD prophylaxis as per institutional guidelines

Sponsors & Collaborators

  • Regimmune Corporation

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2015-06-30
Completion
2017-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01379209 on ClinicalTrials.gov