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Trials / Completed

CompletedNCT03128359

High Dose Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil in Preventing Graft Versus Host Disease in Patients With Hematological Malignancies Undergoing Myeloablative or Reduced Intensity Donor Stem Cell Transplant

A Pilot Study of Post-transplant High Dose Cyclophosphamide (PTCY) as Part of Graft-Versus-Host Disease (GVHD) Prophylaxis in T-Cell Replete HLA-Mismatched Unrelated Donor (MMUD) Ablative and Reduced Intensity Hematopoietic Cell Transplantation (HCT) for Hematological Malignancies

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
38 (actual)
Sponsor
City of Hope Medical Center · Academic / Other
Sex
All
Age
5 Years – 75 Years
Healthy volunteers
Not accepted

Summary

This pilot phase II trial studies how well high dose cyclophosphamide, tacrolimus, and mycophenolate mofetil work in preventing graft versus host disease in patients with hematological malignancies undergoing myeloablative or reduced intensity donor stem cell transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft versus host disease). Giving high dose cyclophosphamide, tacrolimus, and mycophenolate mofetil after the transplant may stop this from happening.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the graft versus host disease (GVHD)-free relapse/progression-free survival (GRFS) at one-year post hematopoietic cell transplantation (HCT) and to evaluate the clinical activity of post-transplant high dose cyclophosphamide (PTCy). SECONDARY OBJECTIVES: I. To summarize toxicities/complications/infections including type, frequency, severity, attribution, time course and duration through 100 days post-transplant. II. To estimate the cumulative incidence (CI) of acute and chronic GVHD. III. To characterize the time course of neutrophil and platelet recovery/engraftment. IV. To estimate overall survival (OS), progression-free survival (PFS), CI of relapse/progression and non-relapse mortality (NRM) at 100 days, 1 year and 2 years. V. To describe quality of life at 100 days, 6 months, 1 and 2 years. VI. To characterize immune cell reconstitution and T cell repertoire post high dose cyclophosphamide in mismatched donor HCT. VII. To characterize quality of life. OUTLINE: CONDITIONING REGIMEN: Patients are assigned to 1 of 3 conditioning regimens at the discretion of the attending physician and principal investigator. REGIMEN A (REDUCED INTENSITY CONDITIONING): Patients receive fludarabine phosphate intravenously (IV) over 60 minutes on days -7 to -3 and melphalan hydrochloride IV over 20 minutes on day -2. REGIMEN B (MYELOABLATIVE CONDITIONING \[MAC\]): Patients receive fludarabine phosphate IV over 1-3 hours and busulfan IV over 3 hour on days -5 to -2. REGIMEN C (MAC): Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -5 and total body irradiation (TBI) twice daily (BID) on days -4 to -1. TRANSPLANT: Patients undergo peripheral blood stem cell (PBSC) hematopoietic cell transplantation (HCT) on day 0. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or orally (PO) thrice daily (TID) beginning on day 5 and stopping on day 35 if no severe GVHD is present, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up twice weekly for 100 days, twice monthly for 6 months, monthly until no evidence of GVHD, and then yearly for up to 2 years.

Conditions

Interventions

TypeNameDescription
DRUGBusulfanGiven IV
DRUGCyclophosphamideGiven IV
DRUGFludarabine PhosphateGiven IV
PROCEDUREHematopoietic Cell TransplantationUndergo PBSC HCT
OTHERLaboratory Biomarker AnalysisCorrelative studies
DRUGMelphalan HydrochlorideGiven IV
DRUGMycophenolate MofetilGiven IV or PO
PROCEDUREPeripheral Blood Stem Cell TransplantationUndergo PBSC HCT
OTHERQuality-of-Life AssessmentAncillary studies
DRUGTacrolimusGiven IV
RADIATIONTotal-Body IrradiationUndergo TBI

Timeline

Start date
2017-05-30
Primary completion
2020-08-01
Completion
2021-09-15
First posted
2017-04-25
Last updated
2024-01-09
Results posted
2023-06-09

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03128359. Inclusion in this directory is not an endorsement.

High Dose Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil in Preventing Graft Versus Host Disease in Patients Wi (NCT03128359) · Clinical Trials Directory