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Stem Cell Transplant

Stem Cell Transplant for Leukemia

Q: Has the FDA sanctioned Regimen A: TBI/Thiotepa/Cyclophosphamide for therapeutic use?

<p>The safety of Regimen A: <a href="https://www.withpower.com/clinical-trials/tbi">TBI</a>/Thiotepa/Cyclophosphamide has been rated a 2, as the data available only verifies its safety and not efficacy.</p>

Phase 2

Waitlist Available

Led By Guenther Koehne, MD, PhD

Research Sponsored by Guenther Koehne

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two years

Awards & highlights

Study Summary

This trial will see if an investigational device helps reduce complications for blood stem cell transplants.

Who is the study for?

This trial is for adults aged 18-74 with certain types of leukemia or lymphoma, such as AML not in 'good risk' remission, ALL/CLL at high relapse risk or second remission, CML unresponsive to specific drugs, and some non-Hodgkin's lymphomas. Participants need a performance status of ≥70%, no active infections or HIV/HTLV, not pregnant/breastfeeding, and must have good heart, liver, kidney and lung function.Check my eligibility

What is being tested?

The study tests if using the CliniMACS system to process blood stem cell transplants can reduce complications in patients with blood cancers/disorders. It involves conditioning treatments like TBI (Total Body Irradiation), Thiotepa, Cyclophosphamide among others before transplanting CD34+ selected cells.See study design

What are the potential side effects?

Potential side effects include those related to chemotherapy and radiation such as nausea/vomiting, fatigue, hair loss; organ toxicity affecting the heart/liver/kidneys/lungs; increased infection risk due to immune suppression; graft-versus-host disease from the transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and two 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

Change in disease free survival (DFS)

Change in overall survival (OS)

Incidence of transplant-related mortality (TRM)

+2 more

Secondary outcome measures

Proportion of patients optimal and suboptimal doses

Trial Design

2Treatment groups

Experimental Treatment

Group I: Regimen B: Busulfan/Melphalan/FludarabineExperimental Treatment3 Interventions

Patients in enrolled in Regimen B will receive the following: Busulfan, IV 0.8 mg/kg q6hours x 10 or 12 doses over 3 days, depending on the disease Melphalan, 70 mg/m^2/day x 2 days via IV infusion over 30 minutes daily Fludarabine, 25 mg/m^2/day x 5 days via IV infusion over 30 minutes daily

Group II: Regimen A: TBI/Thiotepa/CyclophosphamideExperimental Treatment3 Interventions

Patients in enrolled in Regimen A will receive the following: Total Body Irradiation (TBI), hyper-fractionated to a dose of 1320 cGy depending on age, stage of disease and requirement of general anesthesia with lung shielding Thiotepa, 5 mg/kg/day x 2 days via IV infusion over 4 hours daily or 10 mg/kg on one day Cyclophosphamide, 60 mg/kg/day x 2 days via IV infusion over 2 hours daily (or if cyclophosphamide is contraindicated, fludarabine at 25 mg/m^2 x 5 days may be substituted)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 3

~1100

Thiotepa

2008

Completed Phase 3

~2150

Cyclophosphamide

1995

Completed Phase 3

~3770

Busulfan

2008

Completed Phase 3

~1120

Total Body Irradiation (TBI)

2016

Completed Phase 3

~1220

Melphalan

2008

Completed Phase 3

~1500

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Guenther KoehneLead Sponsor

2 Previous Clinical Trials

70 Total Patients Enrolled

Baptist Health South FloridaLead Sponsor

48 Previous Clinical Trials

7,731 Total Patients Enrolled

Guenther Koehne, MD, PhDPrincipal InvestigatorBaptist Health South Florida/Miami Cancer Institute

3 Previous Clinical Trials

33 Total Patients Enrolled

Media Library

CD34+ Transplants (Stem Cell Transplant) Clinical Trial Eligibility Overview. Trial Name: NCT05565105 — Phase 2

Acute Lymphoblastic Leukemia Research Study Groups: Regimen A: TBI/Thiotepa/Cyclophosphamide, Regimen B: Busulfan/Melphalan/Fludarabine

Acute Lymphoblastic Leukemia Clinical Trial 2023: CD34+ Transplants Highlights & Side Effects. Trial Name: NCT05565105 — Phase 2

CD34+ Transplants (Stem Cell Transplant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05565105 — Phase 2

Frequently Asked Questions

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

Am I eligible to partake in this clinical experiment?

"This clinical trial is enlisting 100 participants aged 18 to 74 with acute myeloid leukemia, intermediate or high-grade lymphomas who have either failed to achieve a first complete remission (CR) following initial treatment or relapsed after such a response and cannot undergo autologous transplants. Additionally, this study considers those with any type of non-Hodgkin's Lymphoma that has achieved remission but is not curable through chemotherapy alone; Acute Myelogenous Leukemia in its first remission lacking favourable cytogenetic features; Secondary AML also in its 1st remission; ALL/CLL in patient remissions exhibiting"

Answered by AI

Are there opportunities for individuals to register in the current clinical trial?

"According to records on clinicaltrials.gov, this trial is inactive and not currently recruiting participants. It was first posted on January 1st 2023 before being last updated in late November 2022. Nevertheless, there are still 1551 other trials actively searching for patients at present time."

Answered by AI

Do elderly citizens aged 85 and above qualify for this research?

"This study is only open to adults between the ages of 18 and 74. For those that fall outside this age range, there are 475 trials available for minors and 1,234 clinical studies dedicated towards elderly people."

Answered by AI