Factors Affecting Post-transplant Cyclophosphamide (PTCy) Efficacy

Conditions

• Leukemia, Not Otherwise Specified
• Leukemia, Other

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cyclophosphamide — DRUG
  Pharmacogenomics of candidate genes and pharmacokinetic analyses of cyclophosphamide administered as part of a reduced intensity conditioning (RIC) regimen and as post-transplant GVHD prophylaxis will be examined.
• Specimen collection — OTHER
  Buccal swabs will be obtained from donors for pharmacogenomics.

Study Details

This study will examine the influence of donor and recipient pharmacogenetics (PG), drug pharmacokinetics (PK), and T cell phenotypes and how it may permit a tailored dosing strategy to improve the therapeutic index of post-transplant cyclophosphamide (PTCy) and optimize the graft versus tumor effect, while minimizing acute and chronic graft versus host disease (GVHD).

Key Dates

Start date

Jul 13, 2018

Status verified

Jan 2026

Primary completion

Oct 31, 2033

Completion

Aug 31, 2035

Study Design

Enrollment

120 participants (estimated)

Arms

• Arm: Recipient
  Cyclophosphamide
• Arm: Donor
  Specimen collection

Primary Outcome Measure

Comparison of Cy cMax Values [ Time Frame: Approx. 24 mos ]

Central Contacts

• Elizabeth Parke
  980-442-2011
  [email protected]

Locations (1)

Find similar trials in Charlotte, NC

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