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Shorter Course Tacrolimus After Nonmyeloablative, Related Donor BMT With High-dose Posttransplantation Cyclophosphamide

NCT01342289 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2018-10-17

No results posted yet for this study

Summary

This research is being done to learn more about nonmyeloablative bone marrow transplantation (BMT), also known as a "mini" transplant for patients with blood cancers, using bone marrow from a relative.

Conditions

Interventions

DRUG

Cyclophosphamide

Days -6 and -5: 14.5 mg/kg/day IV. Days 3 and 4: 50 mg/kg/day IV.

DRUG

Fludarabine

Days -6, -5, -4, -3, and -2: 30 mg/m\^2/day IV.

RADIATION

Total body irradiation

Day -1: 200 centigray in one fraction.

DRUG

Mycophenolate Mofetil

Days 5 to 35: 15 mg/kg PO three times per day; max daily dose 1 g.

DRUG

Tacrolimus 60

Begin dosing at 1 mg IV daily on Day 5. Dose is titrated according to serum levels. Stop at Day 60.

DRUG

Tacrolimus 90

Begin dosing at 1 mg IV daily on Day 5. Dose is titrated according to serum levels. Stop at Day 90.

DRUG

Tacrolimus 120

Begin dosing at 1 mg IV daily on Day 5. Dose is titrated according to serum levels. Stop at Day 120.

BIOLOGICAL

Bone marrow transplant

Donor stem cells infused IV on Day 0.

Sponsors & Collaborators

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Richard Jones, M.D. · Johns Hopkins University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
6 Months
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT01342289 on ClinicalTrials.gov