UnknownPhase 2/3

The Effect of Folinic Acid Rescue Following MTX GVHD Prophylaxis on Regimen Related Toxicity and Transplantation Outcome

160 participantsStarted 2015-10

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of severe (grade 3-4) oral mucositis according to the WHO scale

Timeframe: 30 days

Duration (in days) of severe (grade 3-4) oral mucositis according to the WHO scale

Timeframe: 30 days

Trial details

NCT IDNCT02506231

SponsorRabin Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-10

Contact for this trial

Moshe Yeshurun, MD

972-50-4065543 moshey@clalit.org.il

View on ClinicalTrials.gov More Graft vs Host Disease trials