Graft vs Host Disease Clinical Trial
Official title:
The Effect of Folinic Acid Rescue Following Methotrexate (MTX) Graft-versus-host Disease (GVHD) Prophylaxis on Regimen Related Toxicity and Transplantation Outcome: a Double Blind Randomized Controlled Study
The purpose of this study is to assess the impact of folinic acid (FA) -rescue following methotrexate (MTX) graft-versus-host disease (GVHD) prophylaxis on regimen related toxicity and transplantation outcomes after allogeneic hematopoietic cell transplantation (alloHCT) in a double blind randomized controlled trial.
Status | Not yet recruiting |
Enrollment | 160 |
Est. completion date | |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Acute leukemia in complete remission (CR) or myelodysplastic syndrome; - First transplantation; - Peripheral blood graft; - Matched sibling or unrelated donor or one antigen or allelic mismatched sibling or unrelated donor (10/10 or 9/10 human leukocyte antigen match ); - Myeloablative or reduced intensity preparative regimen; - Post-transplant GVHD prophylaxis consisting of a calcineurin inhibitor (CSA or tacrolimus) and methotrexate; - Glutamate Pyruvate Transaminase (GPT) < 3 times upper normal limit (UNL) and creatinine = 1.4 mg%; - Written informed consent; Exclusion Criteria: - True non-myeloablative preparative regimen (TBI 200 +/- fludarabine); - Acute leukemia not in remission; - GPT > 3 times upper normal limit or creatinine > 1.4 mg%; - Bone marrow, haploidentical or cord blood grafts; |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Rabin Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of severe (grade 3-4) oral mucositis according to the WHO scale | According to the WHO (world health organization) oral mucositis grading scale | 30 days | No |
Primary | Duration (in days) of severe (grade 3-4) oral mucositis according to the WHO scale | According to the WHO (world health organization) oral mucositis grading scale | 30 days | No |
Secondary | Incidence of oral mucositis | 30 days | No | |
Secondary | Grade of oral mucositis | According to the WHO (world health organization) oral mucositis grading scale | 30 days | No |
Secondary | Time to neutrophil recovery | 30 days | No | |
Secondary | Time to platelet recovery | 60 days | No | |
Secondary | Adherence to methotrexate schedule | Number of methotrexate doses that were actually given (out of 3 doses on days 1, 3 and 6) | 14 days | No |
Secondary | Adherence to methotrexate doses | Actual methotrexate doses given in mg/sqm divided by scheduled doses in mg/sqm X 100 | 14 days | No |
Secondary | Days of opiate use | 30 days | No | |
Secondary | Days of total parenteral nutrition use | 100 days | No | |
Secondary | Incidence of veno-occlusive disease of the liver (VOD) | 30 days | Yes | |
Secondary | Severity of veno-occlusive disease of the liver (VOD) | According to the Seattle criteria | 30 days | Yes |
Secondary | Incidence of renal toxicity | Creatinine > 2 mg% | 30 days | Yes |
Secondary | Incidence of hepatic toxicity | total bilirubin > 2 mg%, unless mostly indirect | 30 days | No |
Secondary | Incidence of febrile neutropenia | 30 days | No | |
Secondary | Duration of febrile neutropenia | 30 days | No | |
Secondary | Documented infections | 30 days | No | |
Secondary | Time from transplantation to discharge | 60 days | No | |
Secondary | Incidence of acute graft-versus-host disease | 100 days | No | |
Secondary | Severity of acute graft-versus-host disease | According to the consensus grading system | 100 days | No |
Secondary | Incidence of chronic graft-versus-host disease | 24 months | No | |
Secondary | Severity of chronic graft-versus-host disease | According to the National Institutes of Health (NIH) consensus criteria | 24 months | No |
Secondary | Incidence of relapse | 24 months | No | |
Secondary | Non relapse mortality | 24 months | No | |
Secondary | Disease free survival | 24 months | No | |
Secondary | Overall survival | 24 months | No |
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