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

H. Lee Moffitt Cancer Center and Research Institute

Status and phase

Completed

Phase 2

Conditions

Acute Graft Versus Host Disease

Treatments

Drug: Tacrolimus (TAC)

Drug: Methotrexate (MTX)

Drug: Rapamycin (RAPA)

Study type

Interventional

Funder types

Other

Identifiers

NCT00803010

IRB 106591

MCC-15372

Details and patient eligibility

About

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).

Full 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.

Enrollment

74 patients

Sex

All

Ages

16 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

74 participants in 2 patient groups

Tacrolimus / Rapamycin (TAC/RAPA)

Active Comparator group

Description:

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.

Treatment:

Drug: Rapamycin (RAPA)

Drug: Tacrolimus (TAC)

Tacrolimus / Methotrexate (TAC/MTX)

Active Comparator group

Description:

Tacrolimus: beginning 3 days before transplant and given for at least 50 days. Methotrexate: given on days 1, 3, 6 and 11, after transplant.

Treatment:

Drug: Methotrexate (MTX)

Drug: Tacrolimus (TAC)