Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04339101 · ClinicalTrials.gov registry record · Phase 2
Itacitinib, Tacrolimus, and Sirolimus for the Prevention of GVHD in Patients With Acute Leukemia, Myelodysplastic Syndrome, or Myelofibrosis Undergoing Reduced Intensity Conditioning Donor Stem Cell Transplantation
A Phase 2 study of Myelodysplastic Syndrome and Acute Leukemia, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
- 1
- Study location
NCT04339101: Active Phase 2 study of Myelodysplastic Syndrome and Acute Leukemia, sponsored by City of Hope Medical Center.
NCT04339101 is a Phase 2 study of Myelodysplastic Syndrome and Acute Leukemia that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 59 participants, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04339101, a Phase 2 study of Myelodysplastic Syndrome and Acute Leukemia, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase IIa trial studies the side effects of itacitinib when given together with standard treatment (tacrolimus and sirolimus), and to see how well it works in preventing graft-versus-host-disease (GVHD) in patients with acute leukemia, myelodysplastic syndrome or myelofibrosis who are undergoing reduced intensity conditioning donor stem cell transplantation. GVHD is a common complication after donor stem cell transplantation, resulting from donor immune cells recognizing recipients' cells and attacking them. Adding itacitinib to tacrolimus and sirolimus may reduce the risk GVHD and ultimately improve overall outcome and survival after donor stem cell transplantation.
Primary Outcome
GRFS is defined as time from the date of transplantation to the first time of observing following events: grade 3-4 acute graft versus host disease (GVHD), chronic GVHD requiring systemic treatment, relapse, or death, whichever occurs first. Kaplan-Meier curve will be generated for GRFS.
Conditions Studied
Interventions
- DRUG Fludarabine
- DRUG Melphalan
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- DRUG Itacitinib Adipate
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2020-11-11 |
| Est. Completion | 2026-01-20 |
| Phase | Phase 2 |
What the registry record for NCT04339101 still lists
NCT04339101 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (71% lower).
The record links to 5 conditions, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 5 interventions - of which Fludarabine is the first listed.
NCT04339101 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04339101 about?
NCT04339101 is a clinical study titled "Itacitinib, Tacrolimus, and Sirolimus for the Prevention of GVHD in Patients With Acute Leukemia, Myelodysplastic Syndrome, or Myelofibrosis Undergoing Reduced Intensity Conditioning Donor Stem Cell Transplantation". This phase IIa trial studies the side effects of itacitinib when given together with standard treatment (tacrolimus and sirolimus), and to see how well it works in preventing graft-versus-host-disease (GVHD) in patients with acute leukemia, myelodysplastic syndrome or myelofibrosis who are undergoin...
What is the current status of trial NCT04339101?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2020-11-11. Estimated completion is 2026-01-20.
What conditions does trial NCT04339101 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome, Acute Leukemia, Primary Myelofibrosis, Secondary Myelofibrosis, Hematologic and Lymphocytic Disorder.
What interventions are being tested in trial NCT04339101?
The interventions under investigation include: Fludarabine (DRUG), Melphalan (DRUG), Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Itacitinib Adipate (DRUG).
Who is sponsoring clinical trial NCT04339101?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04339101 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Myelodysplastic Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04339101's enrollment target sits among peer trials
59 56th of 134 higher than 79 of 134 other Myelodysplastic Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Trial of 2 Step ATG for Prevention of Acute GVHD Post Allogeneic Stem Cell Transplant
RECRUITING · Phase 2
-
Enasidenib and Azacitidine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia and IDH2 Gene Mutation
RECRUITING · Phase 2
-
Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)
RECRUITING · Phase 2
-
CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
RECRUITING · Phase 2
-
Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases
RECRUITING · Phase 2
-
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03801083 · 59 participants · Phase 2
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers
- NCT04332367 · 59 participants · Phase 2
Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance
- NCT05489575 · 59 participants · NA
CPAP for the Treatment of Supine Hypertension
- NCT06721689 · 59 participants · Phase 1
PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI