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Chemotherapy

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

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

No Placebo-Only Group

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Infection Free Survival

Secondary study objectives

Cumulative incidence of acute GvHD

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

Cumulative incidence of grades 2-3 BK virus hemorrhagic cystitis

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2010

Completed Phase 4

~2310

Mesna

2003

Completed Phase 2

~1380