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Chemotherapy

Reduced-Dose Cyclophosphamide for Leukemia After Stem Cell Transplant (OPTIMIZE Trial)

Q: What risks have been identified with the Regimen A (MAC: Busulfan and Fludarabine, PBSC HCT; Reduce Dose PTCy) protocol?

<p>Our team at Power assessed the safety of Regimen A (<a href="https://www.withpower.com/clinical-trials/mac">MAC</a>: Busulfan and Fludarabine, PBSC HCT; Reduce Dose PTCy) as a 2 due to there being preliminary evidence from Phase 2 trials demonstrating its safety but no efficacy data.</p>

Phase 2

Recruiting

Led By Steven Devine, MD

Research Sponsored by Center for International Blood and Marrow Transplant Research

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 1-year post-hct

Awards & highlights

OPTIMIZE Trial Summary

This trial tests a lower dose of drug to reduce infections after a bone marrow transplant from an unrelated donor.

Who is the study for?

Adults aged 18-66 with various blood cancers, who can consent and follow the trial procedures. They must have a partially matched unrelated donor for stem cell transplant and be in good enough health to undergo the procedure. Specific conditions like AML or ALL should be in early remission.Check my eligibility

What is being tested?

The trial tests if a lower dose of Post-Transplant Cyclophosphamide after stem cell transplantation from mismatched donors is effective at preventing Graft Versus Host Disease while reducing infections within the first 100 days post-transplant.See study design

What are the potential side effects?

Potential side effects include those related to chemotherapy (nausea, hair loss, mouth sores), immunosuppression (increased risk of infection), graft-versus-host disease symptoms (rash, liver dysfunction, digestive issues), and effects from radiation.

OPTIMIZE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-year post-hct

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-year post-hct

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-year 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

Infection Free Survival

Secondary outcome measures

Cumulative incidence of acute GvHD

Cumulative incidence of chronic GvHD

Cumulative incidence of grade 2-3 bacterial, fungal, and viral infections

+13 more

OPTIMIZE Trial Design

5Treatment groups

Experimental Treatment

Group I: Regimen E (NMA: Fludarabine, Cyclophosphamide, and TBI; PBSCT HCT; Reduced Dose PTCyExperimental Treatment9 Interventions

Patients receive: Fludarabine (150mg/m2 total dose) IV on days -6 to -2 Cyclophosphamide (29-50mg/kg) IV on days -6 and -5 TBI (200cGy) on day -1 Patients receive a PBSC graft infusion from a mismatched unrelated donor on Day 0. Patients receive a reduced dose of cyclophosphamide (25mg/kg per dose) on Day 3 and Day 4 post-transplant. First 20 patients with a 4-6/8 mismatched unrelated donor will receive an alternate dose of post-transplant cyclophosphamide of 37.5 mg/kg on Days 3 and Day 4 post-transplant.

Group II: Regimen D (RIC: Fludarabine and Melphalan; PBSCT HCT; Reduced Dose PTCyExperimental Treatment7 Interventions

Patients receive: Fludarabine (125-150 mg/m2 total dose) IV on days -7 to -3 Melphalan (100-140 mg/m2) IV on day -1 Patients receive a PBSC graft infusion from a mismatched unrelated donor on Day 0. Patients receive a reduced dose of cyclophosphamide (25mg/kg per dose) on Day 3 and Day 4 post-transplant. First 20 patients with a 4-6/8 mismatched unrelated donor will receive an alternate dose of post-transplant cyclophosphamide of 37.5 mg/kg on Days 3 and Day 4 post-transplant.

Group III: Regimen C (RIC: Fludarabine and Busulfan; PBSCT HCT; Reduced Dose PTCyExperimental Treatment7 Interventions

Patients receive: Fludarabine (150-180 mg/m2 total dose) IV on days -6 to -2 Busulfan (less than or equal to 8 mg/kg PO or 6.4 mg/kg IV) on days -5 and -4 Patients receive a peripheral blood stem cell (PBSC) graft infusion from a mismatched unrelated donor on Day 0. Patients receive a reduced dose of cyclophosphamide (25mg/kg per dose) on Day 3 and Day 4 post-transplant. First 20 patients with a 4-6/8 mismatched unrelated donor will receive an alternate dose of post-transplant cyclophosphamide of 37.5 mg/kg on Days 3 and Day 4 post-transplant.

Group IV: Regimen B (MAC: Fludarabine and TBI, PBSC HCT; Reduce Dose PTCyExperimental Treatment7 Interventions

Patients receive: Fludarabine (90 mg/m2 total dose) IV on days -7 to -5 Total body irradiation (TBI) (1200 cGy total dose) on days -4 to -1 Patients receive a peripheral blood stem cell (PBSC) graft infusion from a mismatched unrelated donor on Day 0. Patients receive a reduced dose of cyclophosphamide (25mg/kg per dose) on Day 3 and Day 4 post-transplant. First 20 patients with a 4-6/8 mismatched unrelated donor will receive an alternate dose of post-transplant cyclophosphamide of 37.5 mg/kg on Days 3 and Day 4 post-transplant.

Group V: Regimen A (MAC: Busulfan and Fludarabine, PBSC HCT; Reduce Dose PTCyExperimental Treatment7 Interventions

Patients Receive: Patients receive: Busulfan (≥ 9 mg/kg total dose) IV or PO on days -6 to -3 Fludarabine (150 mg/m2 total dose) IV on days -6 to -2 Patients receive a peripheral blood stem cell (PBSC) graft infusion from a mismatched unrelated donor on Day 0. Patients receive a reduced dose of cyclophosphamide (25mg/kg per dose) on Day 3 and Day 4 post-transplant. First 20 patients with a 4-6/8 mismatched unrelated donor will receive an alternate dose of post-transplant cyclophosphamide of 37.5 mg/kg on Days 3 and Day 4 post-transplant.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3770

Mesna

2003

Completed Phase 2

~1380

Melphalan

2008

Completed Phase 3

~1500

Mycophenolate Mofetil

1997

Completed Phase 4

~2380

Busulfan

2008

Completed Phase 3

~1120

Fludarabine

2012

Completed Phase 3

~1100

Tacrolimus

2011

Completed Phase 4

~4740

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Marrow Donor ProgramOTHER

60 Previous Clinical Trials

202,370 Total Patients Enrolled

Center for International Blood and Marrow Transplant ResearchLead Sponsor

38 Previous Clinical Trials

200,193,240 Total Patients Enrolled

Steven Devine, MDPrincipal InvestigatorNMDP

4 Previous Clinical Trials

390 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 risks have been identified with the Regimen A (MAC: Busulfan and Fludarabine, PBSC HCT; Reduce Dose PTCy) protocol?

"Our team at Power assessed the safety of Regimen A (MAC: Busulfan and Fludarabine, PBSC HCT; Reduce Dose PTCy) as a 2 due to there being preliminary evidence from Phase 2 trials demonstrating its safety but no efficacy data."

Answered by AI

Are there still open slots for participants in this experiment?

"According to information from clinicaltrials.gov, this trial is not presently recruiting patients. First posted on November 1st 2023 and last updated August 14th 2023, no new participants are being sought out at the moment; however, there are still 5560 other trials that require volunteers."

Answered by AI

How many sites are hosting this experimental endeavor?

"At this time, patients can join the clinical trial at 6 different sites. These locations include Miami, Boston and Detroit as well as 3 other cities. To reduce any travel necessities associated with your participation in the study, it is best to choose a site closest to you."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation With Reduced Dose Post Transplantation Cyclophosphamide GvHD Prophylaxis

2023. "HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation With Reduced Dose Post Transplantation Cyclophosphamide GvHD Prophylaxis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06001385.

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