Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders (NCT03314974) | Clinical Trial Compass
RecruitingPhase 2
Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders
United States300 participantsStarted 2018-03-30
Plain-language summary
This is a Phase II study of allogeneic hematopoietic stem cell transplant (HCT) using a myeloablative preparative regimen (of either total body irradiation (TBI); or, fludarabine/busulfan for patients unable to receive further radiation). followed by a post-transplant graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF).
Who can participate
Age range
60 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:
* Age: ≤ 60 years of age
* Performance Status: Karnofsky ≥ 70%, Lansky play score ≥ 70
* Consent: Voluntary written consent (adult or legally authorized representative; or parental/guardian)
* Adequate Organ Function:
* Renal: Creatinine \<2x upper limit of normal. Patients above this limit must have creatinine clearance ≥ 40 ml/min/1.73m2 as determined by an age-appropriate method, such as cystatin C GFR.
* Hepatic: Bilirubin, AST, alkaline phosphatase \<4 times the upper limit of institutional normal
* Pulmonary: Diffusion capacity of oxygen, corrected for hemoglobin, \> 50% of predicted. For pediatric patients not able to undergo PFTs or diffusion testing: O2 sat of \>95% on room air
* Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \> 45%. For children not able to cooperate with MUGA or echocardiography, such should be clearly stated in the physician's documentation
* HIV Status: HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation
Other Inclusion Criteria:
* Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.
* Donor Availability: Patients considered for transplantation must have a sufficient graft as based on current criteria of…
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.
1This trial is specifically measuring rates of chronic graft-versus-host disease at one year — how likely is it that I could develop chronic GVHD after this transplant, and what would that mean for my daily life?
2Since this is a myeloablative transplant, my immune system would be completely wiped out before the donor cells are given — given my specific diagnosis and overall health, how does my doctor weigh the risks of that intense conditioning approach against the potential benefit?
3The trial accepts both related and unrelated donors — if I don't have a matched family member, how does using an unrelated donor change my risk profile for complications like GVHD or graft failure compared to a related donor?
4This is a Phase 2 trial, meaning researchers are still building evidence about how well this approach works — is there a standard-of-care transplant protocol already available to me that has more established safety and outcome data that we should consider first?
5Given the wide range of blood cancers this trial enrolls, can my doctor explain how outcomes for patients with my specific diagnosis have looked in similar myeloablative transplant studies, so I can better understand whether this trial makes sense for my situation?
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
1
Chronic GVHD - 1 year
Timeframe: 1 year
Trial details
NCT IDNCT03314974
SponsorMasonic Cancer Center, University of Minnesota