Graft-Versus-Host Disease (GVHD) Prophylaxis After Allogeneic Peripheral Blood Hematopoietic Cell Transplantation

NCT ID: NCT00803010

Last Updated: 2015-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2012-12-31

Brief Summary

The purpose of this research is to compare the effectiveness of Tacrolimus and Rapamycin to Tacrolimus and Methotrexate in the prevention of severe graft-versus-host-disease. Graft-versus-host-disease (GVHD) is a risk associated with allogeneic hematopoietic cell transplants (HCT). An allogeneic hematopoietic cell transplant is a transplant using bone marrow and blood cells that come from someone other than the patient (a donor).

Detailed Description

All drugs used in this study have been used in the prevention of graft-versus-host-disease after allogeneic hematopoietic cell transplant. Tacrolimus and Methotrexate used in combination are currently used as standard of care in the prevention of graft-versus-host-disease after allogeneic hematopoietic cell transplant. Tacrolimus and Rapamycin is a newer combination we are testing to see if it would be better than Tacrolimus and Methotrexate.

Conditions

Acute Graft Versus Host Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Tacrolimus / Rapamycin (TAC/RAPA)

Tacrolimus: beginning 3 days before transplant and given for at least 50 days.

Rapamycin: given the day before transplant and continued daily for at least one year.

Group Type: ACTIVE_COMPARATOR

Tacrolimus (TAC)

Intervention Type: DRUG

Tacrolimus: administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.

Rapamycin (RAPA)

Intervention Type: DRUG

Rapamycin: initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily.

Tacrolimus / Methotrexate (TAC/MTX)

Tacrolimus: beginning 3 days before transplant and given for at least 50 days.

Methotrexate: given on days 1, 3, 6 and 11, after transplant.

Group Type: ACTIVE_COMPARATOR

Tacrolimus (TAC)

Intervention Type: DRUG

Tacrolimus: administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.

Methotrexate (MTX)

Intervention Type: DRUG

Methotrexate: administered on day 1 at dose of 15 mg/m\^2, and a dose of 10 mg/m\^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance.

Interventions

Tacrolimus (TAC)

Tacrolimus: administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.

Intervention Type: DRUG

Methotrexate (MTX)

Methotrexate: administered on day 1 at dose of 15 mg/m\^2, and a dose of 10 mg/m\^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance.

Intervention Type: DRUG

Rapamycin (RAPA)

Rapamycin: initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily.

Intervention Type: DRUG

Other Intervention Names

FK-506; fujimycin; Prograf; Advagraf; Protopic; Trexall; Rheumatrex; Sirolimus

Eligibility Criteria

Inclusion Criteria

• Age ≥ 16 and ≤ 70
• Signed informed consent
• Adequate vital organ function
• No active infection, or asymptomatic infection well controlled by antibiotic HIV negative by ELISA or RT-PCR [if ELISA is positive and RT-PCR is negative, the ELISA is considered false positive]
• Hepatitis B and C negative by serology or RT-PCR
• Performance status: Karnofsky Performance Status Score ≥ 60%.

Exclusion Criteria

• Those with any Sorror's co-morbidity factors with score > 3
• 2 or more Sorror's factors with composite score of ≥ 3

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claudio Anasetti, MD

Role: STUDY_DIRECTOR

HLeeMoffittCancerCenter

Locations

H.Lee Moffitt Cancer Center

Tampa, Florida, United States

Countries

United States

References

Pidala J, Kim J, Jim H, Kharfan-Dabaja MA, Nishihori T, Fernandez HF, Tomblyn M, Perez L, Perkins J, Xu M, Janssen WE, Veerapathran A, Betts BC, Locke FL, Ayala E, Field T, Ochoa L, Alsina M, Anasetti C. A randomized phase II study to evaluate tacrolimus in combination with sirolimus or methotrexate after allogeneic hematopoietic cell transplantation. Haematologica. 2012 Dec;97(12):1882-9. doi: 10.3324/haematol.2012.067140. Epub 2012 Jun 11.

Reference Type: DERIVED

PMID: 22689677 (View on PubMed)

Related Links

http://www.moffitt.org/

H.Lee Moffitt Cancer Center \& Research Institute

Other Identifiers

IRB 106591

Identifier Type: -

Identifier Source: secondary_id

MCC-15372

Identifier Type: -

Identifier Source: org_study_id