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NCT03963024: TrRaMM-TMI

Treosulfan-TMI Conditioning and Rapamycin GvHD Prophylaxis Before Allo-HSCT

Terminated Phase 1 Last updated 19 October 2020
What this trial tests

Phase 1 trial testing Conditioning treatment "Treosulfan-TMI" in Irradiated Bone Marrow in 9 participants. Terminated before completion.

Timeline
12 February 2014
Primary endpoint
31 January 2019
31 January 2019

Quick facts

Lead sponsorIRCCS San Raffaele
PhasePhase 1
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment9
Start date12 February 2014
Primary completion31 January 2019
Estimated completion31 January 2019
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

IRCCS San Raffaele — full company profile →

Who can join

Adults 18 to 70, any sex, with Irradiated Bone Marrow or Transplant-Related Hematologic Malignancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

TrRaMM-TMI is a phase I trial to evaluate the feasibility and efficacy of an original sequential TMI/TrRaMM (Total Marrow Irradiation/Treosulfan-Rapamycin-Mycophenolate Mofetil) schedule in patients with hematological malignancies in advanced stage of disease undergoing an allogenic Stem Cell Transplant (SCT). The aim is to determine the maximum tolerated dose of TMI when combined with conditioning chemotherapy to transplant according to TrRaMM schedule.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The Role of mTOR Inhibitors in Hematologic Disease: From Bench to Bedside.
    Feng Y, Chen X, Cassady K, Zou Z, et al · · 2020 · cited 38× · PMID 33489922 · DOI 10.3389/fonc.2020.611690

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Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03963024.

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