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Pharmacologic Pretransplant Immunosuppression (PTIS) + Reduced Toxicity Conditioning (RTC) Allogeneic Stem Cell Transplantation in Inherited Hematologic Disorders

NCT05293509 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-09-21

No results posted yet for this study

Summary

To assess the outcomes of NRM when administering pharmacologic pretransplant immunosuppression (PTIS) followed by pretransplant reduced toxicity conditioning (RTC) and an allogeneic stem cell transplant (allo-SCT) and post-transplant graft-versus-host disease prophylaxis based on post-transplant cyclophosphamide (PT-Cy) in patients with inherited blood disorders.

Conditions

  • Stem Cell Transplantation

Interventions

DRUG

Fludarabine

40 mg/m2/day i.v.- by vein

DRUG

Dexamethasone

25 mg/m2/day i.v.-by vein

DRUG

Cyclophosphamide

100 mg/m2 IV-by vein

DRUG

Bortezomib

Four doses of bortezomib at a dose of 1.3 mg/m2 -injection under the skin

DRUG

Rituximab

Four doses of rituximab at a dose of 375 mg/m2- by vein

DRUG

Busulfan

110 mg/m2 i.v-by vein

DRUG

Cyclophosphamide (Cy)

by vein

DRUG

Tacrolimus (or cyclosporine)

by vein

DRUG

Mycophenolate mofetil (MMF)

given by PO

DRUG

Rabbit ATG

by vein

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Jeremy Ramdial, Ramdial · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-02
Primary Completion
2023-09-18
Completion
2023-09-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05293509 on ClinicalTrials.gov