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Tacrolimus and Mycophenolate Mofetil as Post-Grafting Immunosuppression

NCT02178683 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-07-01

No results posted yet for this study

Summary

This protocol will evaluate Tacrolimus and MMF after conditioning with fludarabine and low-dose TBI in patients who are not candidates for conventional allografting. A novel approach to immunosuppression will be tested incorporating an early but extended taper of Tacrolimus starting on day +80 or in the case of relapse. The goal is to induce early immunity and GVT effects without compromising GVHD control. The anti-metabolite MMF will be re-introduced on day +100 to try and induce tolerance and block chronic GVHD during the taper of the Tacrolimus. DLI may be given in the presence of disease progression but not for mixed chimerism as in previous protocols.

Conditions

Interventions

DRUG

Tacrolimus and MMF.

First dose of Tacrolimus is given day -4, this continues through day +365. First dose of MMF is given within 4 hours of stem cell infusion, this continues through day +365.

Sponsors & Collaborators

  • Colorado Blood Cancer Institute

    lead OTHER

Principal Investigators

  • Mark W Brunvand, MD · Colorado Blood Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2016-12-31
Completion
2018-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02178683 on ClinicalTrials.gov