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Stem Cell Transplantation

Stem Cell Transplantation for Leukemia

Phase 3
Recruiting
Led By Heather J Symons
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1-year post-hct
Awards & highlights

Study Summary

This trial compares stem cell transplants from related or unrelated donors to treat leukemia or MDS in children, teens, & young adults.

Who is the study for?
This trial is for children, adolescents, and young adults aged 6 months to under 22 years with acute leukemia or myelodysplastic syndrome (MDS) who need a stem cell transplant but don't have a matched sibling donor. Participants must be in good health with proper kidney, liver, heart, and lung function. They can't join if they're pregnant, unwilling to use contraception during the study, have uncontrolled infections or certain genetic disorders.Check my eligibility
What is being tested?
The trial compares two types of stem cell transplants: one from mismatched related donors (family members not fully matching) versus another from matched unrelated donors found through registries. It aims to determine which source is better for treating high-risk leukemia or MDS after receiving intensive chemotherapy or radiation therapy.See study design
What are the potential side effects?
Potential side effects include reactions to immune globulin infusions; complications from chemotherapy like nausea and low blood counts; risks associated with lumbar punctures; organ damage due to intense treatment regimens; and graft-versus-host disease where donated cells attack the patient's body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up-to 1-year post-hct
This trial's timeline: 3 weeks for screening, Varies for treatment, and up-to 1-year post-hct for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease free survival (DFS) (where an event is the occurrence of death from any cause or relapse)
Severe GVHD (Grade III-IV acute GVHD or chronic GVHD requiring systemic immunosuppressive therapy)
Secondary outcome measures
Overall survival (OS)
Summary score from the Generic Pediatric Quality of Life Inventory (PedsQL) (excluding School Functioning)
Summary score from the PedsQL Stem Cell Transplant module
Other outcome measures
Acute graft versus host disease (aGVHD) Grades II-IV and III-IV
Graft-versus-host disease (GVHD)-free relapse-free survival (GRFS) (using the standard definition and two landmark definitions)
Mild, moderate, and severe chronic graft versus host disease (cGVHD)
+13 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C (haploHCT)Experimental Treatment20 Interventions
Patients who only have a haplo donor receive a myeloablative conditioning regimen with PTCy or alpha beta T cell depletion at the discretion of the treating provider. Patients then undergo haploHCT on day 0. Patients undergoing myeloablative conditioning regimen with PTCy also receive GVHD prophylaxis on days 3-5. Patients undergo lumbar puncture, bone marrow aspiration, and ECHO or MUGA during screening. Patients also undergo collection of blood throughout the trial.
Group II: Arm B (MUD-HCT)Experimental Treatment17 Interventions
Patients receive a TBI-based or chemotherapy-based myeloablative conditioning regimen between days -9 and -2, followed by MUD-HCT on day 0. Patients then receive GVHD prophylaxis regimen on days 1-11. Patients undergo lumbar puncture, bone marrow aspiration, and ECHO or MUGA during screening. Patients also undergo collection of blood throughout the trial.
Group III: Arm A (halploHCT)Experimental Treatment20 Interventions
Patients receive a myeloablative conditioning regimen with PTCy or alpha beta T cell depletion at the discretion of the treating provider. Patients then undergo haploHCT on day 0. Patients undergoing myeloablative conditioning regimen with PTCy also receive GVHD prophylaxis on days 3-5. Patients undergo lumbar puncture, bone marrow aspiration, and ECHO or MUGA during screening. Patients also undergo collection of blood throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melphalan
2008
Completed Phase 3
~1500
Lumbar Puncture
2016
Completed Phase 3
~510
Methotrexate
2013
Completed Phase 4
~3800
Rituximab
1999
Completed Phase 4
~1880
Fludarabine
2012
Completed Phase 3
~1100
Thiotepa
2008
Completed Phase 3
~2210
Tacrolimus
2011
Completed Phase 4
~4740
Cyclophosphamide
1995
Completed Phase 3
~3770
Echocardiography
2013
Completed Phase 4
~11670
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Total-Body Irradiation
1997
Completed Phase 3
~1180
Biospecimen Collection
2004
Completed Phase 2
~1700
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Busulfan
2008
Completed Phase 3
~1120

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
454 Previous Clinical Trials
237,505 Total Patients Enrolled
Heather J SymonsPrincipal InvestigatorChildren's Oncology Group

Media Library

Myelodysplastic Syndrome Research Study Groups: Arm C (haploHCT), Arm A (halploHCT), Arm B (MUD-HCT)
Myelodysplastic Syndrome Clinical Trial 2023: Haploidentical hematopoietic cell transplantation (haploHCT) Highlights & Side Effects. Trial Name: NCT05457556 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants of 45 years and older eligible to join this trial?

"The age of eligibility for this clinical trial is between 6 months and 22 years old. Notably, there are 836 trials specifically tailored to those under 18 and 2178 studies that focus on the elderly population (65+)."

Answered by AI

Are there any vacancies available for patients to participate in this clinical trial?

"Affirmative. According to clinicaltrials.gov, recruitment for this medical experiment is in full swing since it was first posted on November 21st 2022 and last edited December 6th 2022. The trial requires 435 participants from a single site."

Answered by AI

What is the scale of enrollment for this research endeavor?

"Indeed, clinicaltrials.gov indicates that this medical experiment is actively recruiting participants. The trial was initially posted on November 21st 2022 and has since been amended as of December 6th 2022. 435 individuals are required to be recruited at a single site."

Answered by AI

Has the FDA authorized nonrandomized haploHCT under ARM C?

"Our organization has assigned a score of 3 to ARM C: nonrandomized haploHCT's safety, as it is currently undergoing Phase 3 trials. This indicates that there have been multiple rounds of data collection validating efficacy and safety."

Answered by AI

What are the central goals of this research initiative?

"This medical trial will measure the Cumulative incidence of severe GVHD as its primary outcome over a 12-week period post randomization. Secondary outcomes include PedsQLTM Stem Cell Transplant Module Summary Score to assess differences in HRQOL between haploHCT and MUD HCT, with scores ranging from 0 to 100 (higher is better). Additionally, Overall Survival between haploHCT and MUD HCT will be evaluated through Kaplan Meier method estimation and Cox regression modelling. Finally, if warranted by high percentages of non-compliance (>30%) an 'as-treated' analysis will ensue. Evaluable patients"

Answered by AI

Does my profile meet the criteria for participation in this investigation?

"This medical trial is searching for 435 participants aged between 6 Months and 22 who have received a transplant or stem cell therapy. Along with this, individuals must meet the following criteria: they are of an appropriate age at enrollment; they have not had prior allogenic hematopoietic stem cell transplants; there is an eligible related family donor based on HLA typing; those who possess an 8/8 MUD adult donor may be randomized to Arm A or B.; no other trials can be enrolled in simultaneously; diagnosis of ALL, AML, or MDS which necessitates an allogeneic HSCT treatment plan (CR status"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome
2023. "Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05457556.
~290 spots leftby Dec 2027
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