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Immunosuppressant

Stem Cell Transplant for Aplastic Anemia

Phase 1

Recruiting

Led By Ryotaro Nakamura

Research Sponsored by City of Hope Medical Center

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 from enrollment until non-disease related death or last follow up and from date of cd4+ t-cell-depleted product infusion, assessed up to 3 years

Awards & highlights

Study Summary

This trial tests a reduced-intensity drug regimen prior to a partial-match stem cell transplant to treat severe aplastic anemia. Drugs used may damage cell DNA, block protein needed for cell growth, and suppress immune cells.

Who is the study for?

This trial is for patients aged 40-75 with severe aplastic anemia that's resistant or has returned after treatment. They must have tried immunosuppressive therapy, have a suitable relative as a donor, and meet specific health criteria like proper kidney function and no HIV or hepatitis infections. Women of childbearing age need a negative pregnancy test.Check my eligibility

What is being tested?

The study tests if giving cyclophosphamide, pentostatin, and anti-thymocyte globulin before transplanting stem cells from a half-matched donor can be safe and work well for treating severe aplastic anemia. It aims to prepare the body for new cells and reduce disease complications.See study design

What are the potential side effects?

Possible side effects include immune system suppression leading to increased infection risk, potential damage to DNA by cyclophosphamide which could affect cell growth, allergic reactions to anti-thymocyte globulin, organ inflammation, fatigue, nausea, liver enzyme changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment until non-disease related death or last follow up and from date of cd4+ t-cell-depleted product infusion, assessed up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment until non-disease related death or last follow up and from date of cd4+ t-cell-depleted product infusion, assessed up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment until non-disease related death or last follow up and from date of cd4+ t-cell-depleted product infusion, assessed up to 3 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Ability to meet CD4+ T-cell depleted product release requirements (feasibility)

Ability to meet minimum required cell dose (feasibility)

Incidence of adverse events

Secondary outcome measures

Chimerism

Cumulative incidence of acute GvHD (II-IV and III-IV)

Cumulative incidence of chronic GvHD (any and moderate-severe)

+11 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (conditioning, haploHCT)Experimental Treatment8 Interventions

Patients receive cyclophosphamide PO and IV, pentostatin IV, anti-thymocyte globulin IV and undergo CD4+ T-cell depleted haploHCT on study. Patients also undergo bone marrow aspirate, bone marrow biopsy, and collection of blood samples at screening and follow-up.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pentostatin

2000

Completed Phase 3

~1300

Bone Marrow Biopsy

2021

Completed Phase 2

~10

Bone Marrow Aspirate

2015

Completed Phase 3

~40

Anti-Thymocyte Globulin

2009

Completed Phase 4

~980

Biospecimen Collection

2004

Completed Phase 2

~1700

Cyclophosphamide

1995

Completed Phase 3

~3770

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)NIH

13,672 Previous Clinical Trials

40,926,435 Total Patients Enrolled

8 Trials studying Aplastic Anemia

1,038 Patients Enrolled for Aplastic Anemia

City of Hope Medical CenterLead Sponsor

567 Previous Clinical Trials

1,922,654 Total Patients Enrolled

2 Trials studying Aplastic Anemia

233 Patients Enrolled for Aplastic Anemia

Ryotaro NakamuraPrincipal InvestigatorCity of Hope Medical Center

5 Previous Clinical Trials

246 Total Patients Enrolled

1 Trials studying Aplastic Anemia

153 Patients Enrolled for Aplastic Anemia

Frequently Asked Questions

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

To what extent does Treatment (conditioning, haploHCT) pose a risk to patients?

"Our team at Power has rated the safety of Treatment (conditioning, haploHCT) a 1 due to limited clinical evidence. This is an initial phase trial, with minimal data on efficacy and safety."

Answered by AI

Is this experiment currently enrolling participants?

"According to clinicaltrials.gov, this medical study has ceased recruiting patients and is no longer viable for participation. The trial was first listed on June 27th 2023 and the last update occured February 23rd of that year. Nonetheless, there are 247 other trials currently running with open enrollment criteria."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Reduced-Intensity Conditioning Regimen (Cyclophosphamide, Pentostatin, Anti-thymocyte Globulin) Followed by Haploidentical Hematopoietic Stem Cell Transplant for the Treatment of Patients With Refractory or Recurrent Severe Aplastic Anemia

2024. "A Reduced-Intensity Conditioning Regimen (Cyclophosphamide, Pentostatin, Anti-thymocyte Globulin) Followed by Haploidentical Hematopoietic Stem Cell Transplant for the Treatment of Patients With Refractory or Recurrent Severe Aplastic Anemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05757310.

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