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Alkylating agents

Thiotepa--escalated dose for Acquired Thrombocytopenia

Q: What is Thiotepa--escalated dose most frequently used to treat?

Thiotepa can be used to fight <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a>, malignant effusion, and urinary bladder at an escalated dose.

Q: Does this research break new ground in the medical field?

Thiotepa--escalated dose has been studied since 2002. The very first trial was completed in 2002 and was sponsored by Schering-Plough. Following the first study in 2002, which involved 60 patients, Thiotepa--escalated dose received its Phase 2 drug approval. Today there are 61 active trials for Thiotepa--escalated dose across 223 cities and 38 countries.

Q: Is the age limit for this research project set at 18 years old or younger?

Children aged 3 months to 39 years old can enroll in this clinical trial. In total, there are 782 trials for people under 18 and 1532 trials for senior citizens.

Q: If I enroll in this study, what am I agreeing to?

Eligibility for this particular clinical trial requires that patients are between 3 months and 39 years old, have bone marrow failure, and there are only six total spots available.

Q: How many people are enrolled in this clinical research project?

This study is not currently searching for patients at this time. The clinical trial was first posted on 6/15/2018 and was most recently edited on 11/7/2022. If you are exploring for other studies, there are currently 2193 clinical trials actively searching for patients with bone marrow failure and 61 studies for Thiotepa--escalated dose actively recruiting patients.

Q: Are investigators looking for more test subjects?

Unfortunately, this study is not enrolling new patients at this time. The trial was first posted on June 15th, 2018 and had its last update on November 7th, 2022. If you are seeking other studies, there are 2193 trials actively looking for patients with bone marrow failure and 61 studies that use Thiotepa--escalated dose actively recruiting patients.

Phase 1 & 2

Waitlist Available

Led By Biljana Horn, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 24

Awards & highlights

Study Summary

This trial is testing a lower dose of thiotepa added to busulfan, fludarabine, and rATG for people with non-malignant diseases undergoing stem cell transplantation.

Eligible Conditions

Acquired Thrombocytopenia
Common Variable Immunodeficiency
Mucopolysaccharidosis
Thalassemia
Bone Marrow Failure Syndrome
Sickle Cell Disease
Chronic Granulomatous Disease
Adrenoleukodystrophy
Severe Combined Immunodeficiency
Lymphoproliferative Disease
Acquired Hemolytic Anemia
Mannosidosis
Neonatal Neutropenia
Wiskott-Aldrich Syndrome
Diamond-Blackfan Anemia
Hemophagocytic Lymphohistiocytosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 24 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Assessment of Minimum Effective Dose (MED) of Thiotepa

Secondary outcome measures

Evaluation of Transplant-related Mortality

Number of Participants With Grade 2-4 Acute Graft-versus-host Disease (GVDH)

Percentage of Participants With Chronic Graft-versus-host Disease (cGVHD)

+4 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Group A--Thiotepa single doseExperimental Treatment1 Intervention

Fully matched 10/10 subjects with lower risk of graft failure. Subjects will undergo 10/10 HLA (human leukocyte antigen) matched bone marrow and peripheral blood transplant. Subjects receive combination of single daily dose thiotepa (5 mg/kg) added to the backbone of targeted reduced dose IV busulfan, fludarabine and rabbit anti-thymocyte globulin (rATG).

Group II: Group A--Thiotepa escalated doseExperimental Treatment1 Intervention

Fully matched 10/10 subjects with lower risk of graft failure. Subjects will undergo 10/10 HLA (human leukocyte antigen) matched bone marrow and peripheral blood transplant. Subjects receive combination of escalated dose of thiotepa (10 mg/kg) added to the backbone of targeted reduced dose IV busulfan, fludarabine and rabbit anti-thymocyte globulin (rATG).

Group III: Group B--Thiotepa escalated doseActive Control1 Intervention

Subjects with higher risk of graft failure. Subjects will undergo transplant with <10/10 bone marrow or peripheral blood match, or receiving cord blood transplant. Subjects receive combination of escalated dose of thiotepa (10 mg/kg)added to the backbone of targeted reduced dose IV busulfan, fludarabine and rabbit anti-thymocyte globulin (rATG).

Group IV: Group B--Thiotepa single doseActive Control1 Intervention

Subjects with higher risk of graft failure. Subjects will undergo transplant with <10/10 bone marrow or peripheral blood match, or receiving cord blood transplant. Subjects receive combination of single daily dose thiotepa (5 mg/kg) added to the backbone of targeted reduced dose IV busulfan, fludarabine and rabbit anti-thymocyte globulin (rATG).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Thiotepa

FDA approved

Thiotepa

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,342 Previous Clinical Trials

715,664 Total Patients Enrolled

Live Like Bella Pediatric Cancer ResearchUNKNOWN

Biljana Horn, MDPrincipal InvestigatorUniversity of Florida

2 Previous Clinical Trials

48 Total Patients Enrolled

Frequently Asked Questions

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

What is Thiotepa--escalated dose most frequently used to treat?

"Thiotepa can be used to fight cancer, malignant effusion, and urinary bladder at an escalated dose."

Answered by AI

Does this research break new ground in the medical field?

"Thiotepa--escalated dose has been studied since 2002. The very first trial was completed in 2002 and was sponsored by Schering-Plough. Following the first study in 2002, which involved 60 patients, Thiotepa--escalated dose received its Phase 2 drug approval. Today there are 61 active trials for Thiotepa--escalated dose across 223 cities and 38 countries."

Answered by AI

Is the age limit for this research project set at 18 years old or younger?

"Children aged 3 months to 39 years old can enroll in this clinical trial. In total, there are 782 trials for people under 18 and 1532 trials for senior citizens."

Answered by AI

If I enroll in this study, what am I agreeing to?

"Eligibility for this particular clinical trial requires that patients are between 3 months and 39 years old, have bone marrow failure, and there are only six total spots available."

Answered by AI

How many people are enrolled in this clinical research project?

"This study is not currently searching for patients at this time. The clinical trial was first posted on 6/15/2018 and was most recently edited on 11/7/2022. If you are exploring for other studies, there are currently 2193 clinical trials actively searching for patients with bone marrow failure and 61 studies for Thiotepa--escalated dose actively recruiting patients."

Answered by AI

Are investigators looking for more test subjects?

"Unfortunately, this study is not enrolling new patients at this time. The trial was first posted on June 15th, 2018 and had its last update on November 7th, 2022. If you are seeking other studies, there are 2193 trials actively looking for patients with bone marrow failure and 61 studies that use Thiotepa--escalated dose actively recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Conditioning Regimen for Allogeneic Hematopoietic Stem-Cell Transplantation

2018. "Conditioning Regimen for Allogeneic Hematopoietic Stem-Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03513328.