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Virus Therapy

Bone Marrow Transplant + GVHD Prophylaxis for Blood Cancer in HIV/AIDS Patients

Phase 1 & 2

Waitlist Available

Led By Jennifer A Kanakry, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 2, 3, 4, and 5 years post hct

Awards & highlights

Study Summary

This trial is testing a new combination of drugs to prevent graft-versus-host disease after bone marrow transplant for people with HIV and a blood cancer.

Eligible Conditions

HIV/AIDS
Blood Cancers

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 2, 3, 4, and 5 years post hct

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1, 2, 3, 4, and 5 years post hct

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 2, 3, 4, and 5 years post hct for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determine a safe and recommended phase II dose level regimen

Graft-vs-Host Disease

Secondary outcome measures

Cumulative incidence of acute GVHD

Cumulative incidence of chronic GVHD

Cumulative incidence of hematopoietic recovery

+6 more

Side effects data

From 2013 Phase 2 trial • 55 Patients • NCT00849147

Pseudomonas infection

Atrial fibrillation

Respiratory distress

Cardiac failure congestive

Respiratory failure

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Haplo-marrow Transplantation

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: 2/Recipient Arm 2Experimental Treatment5 Interventions

RIC+alloHCT+GVHD prophylaxis per RP2D

Group II: 1/Recipient Arm 1Experimental Treatment5 Interventions

RIC+alloHCT+GVHD prophylaxis per dose levels 1, 2, and

Group III: 3/Donor ArmActive Control1 Intervention

Collection of research samples on hematopoietic donors

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RIC

2019

N/A

~110

GVHD prophylaxis

2008

Completed Phase 2

~140

Plerixafor

2011

Completed Phase 3

~720

Maraviroc

2014

Completed Phase 4

~1770

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,657 Previous Clinical Trials

40,933,402 Total Patients Enrolled

Jennifer A Kanakry, M.D.Principal InvestigatorNational Cancer Institute (NCI)

3 Previous Clinical Trials

1,221 Total Patients Enrolled

Media Library

RIC (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05470491 — Phase 1 & 2

HIV/AIDS Research Study Groups: 1/Recipient Arm 1, 2/Recipient Arm 2, 3/Donor Arm

HIV/AIDS Clinical Trial 2023: RIC Highlights & Side Effects. Trial Name: NCT05470491 — Phase 1 & 2

RIC (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05470491 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the intended outcome of this clinical experiment?

"This research project will be evaluated at day +100 post HCT and the primary outcome is a reduction of grade III-IV acute GVHD. Moreover, secondary objectives include an assessment of overall survival via Kaplan-Meier analysis, cumulative incidence of graft failure based on chimerism at both Day+100 and one year post transplantation, as well as the determination of hematopoietic recovery through platelet count data collected at day +100."

Answered by AI

Is the enrollment of participants still open in this trial?

"Unfortunately, according to clinicaltrials.gov this trial is not actively recruiting participants despite being first posted on December 6th 2022 and last edited on November 30th 2022. Nevertheless, there are still 2757 medical studies that are presently enrolling patients worldwide."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Bone Marrow Transplantation Followed by Graft-versus-Host-Disease (GVHD) Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies in People Living With HIV

2023. "Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Bone Marrow Transplantation Followed by Graft-versus-Host-Disease (GVHD) Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies in People Living With HIV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05470491.