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Sirolimus & Mycophenolate Mofetil as GVHD Prophylaxis in Myeloablative, Matched Related Donor HCT

NCT00350181 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2021-09-23

No results posted yet for this study

Summary

GVHD prophylaxis of sirolimus and mycophenolate mofetil for patients undergoing matched related allogeneic transplant for acute and chronic leukemia, MDS, high risk NHL and HL

Conditions

Interventions

DRUG

Sirolimus

Immunosuppressant beginning day -3 with 12 mg oral loading dose, 4 mg/day orally for adults

DRUG

MMF

Immunosuppressant given through IV on day 0 at 15 mg/kg twice daily ≥ 2hr after the completion for the donor cell infusion

DRUG

BCNU

15 mg/kg, IV

DRUG

VP-16

60 mg/kg, IV

DRUG

CY

For subjects aged 18-60 with lymphoma 100 mg/kg, IV For subjects aged with AML, ALL or CML 18-50 60 mg/kg, IV For subjects aged 51-60 with MDS, AML or ALL or patients age 18-60 with MDS, secondary AML or non-CML myeloproliferative disease 45 mg/kg

DRUG

FTBI

1320 cGy delivered in 11 120 cGy fractions over 4 day

DRUG

BU

BU 1 mg/kg every 6hr x 4 doses, IV

Sponsors & Collaborators

Principal Investigators

  • Laura Johnston · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2007-08-31
Completion
2010-04-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT00350181 on ClinicalTrials.gov