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NCT05256537 · ClinicalTrials.gov registry record · Phase 2

Fludarabine and Total Body Irradiation 800 Centigray (cGy) or 1125 cGy For Allogeneic Stem Cell Transplant Using Graft Versus Host Disease Prophylaxis With Post-Transplant Cyclophosphamide and Tacrolimus, Without Mycophenolate Mofetil

A Phase 2 study of Hematologic Neoplasms, sponsored by Ronald Paquette.

Active
Registry status
Phase 2
Development phase
60
Enrollment target
1
Study location

NCT05256537: Active Phase 2 study of Hematologic Neoplasms, sponsored by Ronald Paquette.

NCT05256537 is a Phase 2 study of Hematologic Neoplasms that is active but no longer recruiting, run by Ronald Paquette. The registered enrollment target is 60 participants, below the 1,023-participant average among 20 other Hematologic Neoplasms trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05256537, a Phase 2 study of Hematologic Neoplasms, is active but no longer recruiting, sponsored by Ronald Paquette.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
60 participants
Enrollment target
1
Study location

Study Summary

This is a pilot study to evaluate the feasibility, safety and potential benefits of removing one immune suppressive drug called mycophenolate mofetil (MMF) from the standard allogenic stem cell transplant treatment protocol. MMF will be omitted from the transplant regimen in 60 eligible patients with hematologic malignancies. Participants will be followed for up to 2 years post standard of care transplant at Cedars-Sinai.

Primary Outcome

Evaluate the feasibility of eliminating the drug Mycophenolate Mofetil (MMF) from the transplant regimens as determined by an acceptable rate of engraftment failure (\<10%). Engraftment failure is when the blood-forming cells received on transplant day do not start to grow and make healthy blood cells.

Conditions Studied

Interventions

  • OTHER Omission of the drug mycophenolate mofetil

Study Locations (1)

California

  • Cedars-Sinai Medical Center - Los Angeles

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2022-04-26
Est. Completion 2026-03-07
Phase Phase 2
Ronald Paquette

2 total trials

What the registry record for NCT05256537 still lists

NCT05256537 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,023-participant average among 20 other Hematologic Neoplasms trials with a reported enrollment target (94% lower).

The record links to 1 condition, with Hematologic Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which Omission of the drug mycophenolate mofetil is the first listed.

NCT05256537 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT05256537 about?

NCT05256537 is a clinical study titled "Fludarabine and Total Body Irradiation 800 Centigray (cGy) or 1125 cGy For Allogeneic Stem Cell Transplant Using Graft Versus Host Disease Prophylaxis With Post-Transplant Cyclophosphamide and Tacrolimus, Without Mycophenolate Mofetil". This is a pilot study to evaluate the feasibility, safety and potential benefits of removing one immune suppressive drug called mycophenolate mofetil (MMF) from the standard allogenic stem cell transplant treatment protocol. MMF will be omitted from the transplant regimen in 60 eligible patients wi...

What is the current status of trial NCT05256537?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2022-04-26. Estimated completion is 2026-03-07.

What conditions does trial NCT05256537 study?

This clinical trial studies the following conditions: Hematologic Neoplasms.

What interventions are being tested in trial NCT05256537?

The interventions under investigation include: Omission of the drug mycophenolate mofetil (OTHER).

Who is sponsoring clinical trial NCT05256537?

This trial is sponsored by Ronald Paquette, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05256537 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Hematologic Neoplasms

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05256537's enrollment target sits among peer trials

60 13th of 20 higher than 7 of 20 other Hematologic Neoplasms trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hematologic Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05256537, the US trial registry maintained by the National Library of Medicine. NCT05256537 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.