A Phase 2 interventional study of Cytarabine in Acute Leukemia and Myelodysplastic Syndromes, sponsored by Peking University People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-03-26.
Sponsored by Peking University People's Hospital · Phase 2, Interventional, and Treatment
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Among 60 studies testing cytarabine in Myelodysplastic Syndromes — 10 open to participants now, 11 under way, 1 of them phase 3. Cytarabine · Myelodysplastic Syndromes.
Among the 60 studies testing cytarabine in Myelodysplastic Syndromes, this one is the 25th largest by planned enrollment of the 57 interventional ones that give a count, is one of 4 that started in 2018, is one of 34 in phase 2, reaches primary completion later than 0 of the 10 other live ones, and was the 48th registered.
1,997 studies on the registry are indexed under Myelodysplastic Syndromes; 324 are open to participants now.
Browse Myelodysplastic Syndromes studies →10 of the 60 studies testing cytarabine in Myelodysplastic Syndromes are open now, in 5 countries. Recruiting first, the newest first:
Fujian Medical University Union Hospital · Sites in China
Ages 14–60
Fred Hutchinson Cancer Center · Sites in United States
Ages 18+
National Cancer Institute (NCI) · Sites in United States, Canada, Puerto Rico
Ages 18+
Heinrich-Heine University, Duesseldorf · Sites in Germany
Ages 18+
M.D. Anderson Cancer Center · Sites in United States
Ages 18+
By country, each count listing its studies:
Cytarabine: first FDA approval 1969 (CYTARABINE), first EMA approval 2001. What it is approved for, and how studies give it, is on its page →
Of the 264 Myelodysplastic Syndromes studies recruiting now, 167 (63%) set no upper age limit and 70 (27%) stop at 75 or younger; 57 take children under 18; 17 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
60 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 21 · Phase 2 48 · Phase 3 3
First in 1995; this study’s year is marked. 4 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is above the median of 40 across 1,611 interventional studies indexed under Myelodysplastic Syndromes.
Median enrollment 44 across the 57 interventional studies. Of the 43 that completed or were terminated, 25 (58%) have results posted.
This tab as a report to print or save as PDF → With an account.
3 of 60 have an industry lead sponsor. The 10 most frequent:
Peking University People's Hospital is the lead sponsor of 610 studies on the registry; 248 are open to participants now.
12 studies in Myelodysplastic Syndromes by Peking University People's Hospital: 10 open now, 10 under way, none of them phase 3.
Among the 12 studies in Myelodysplastic Syndromes by Peking University People's Hospital, this one is one of 2 that started in 2018, is one of 6 in phase 2, and was the 2nd registered.
Peking University People's Hospital’s Myelodysplastic Syndromes studies by the year they started, since 2013.
2 of the studies testing cytarabine in Myelodysplastic Syndromes that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03330821University of Southern CaliforniaPevonedistat, Cytarabine, and Idarubicin in Treating Patients With Acute Myeloid Leukemia | 2026-12-31 |
| NCT07046078Fred Hutchinson Cancer CenterCombination Chemotherapy (FLAG-Ida) Followed Immediately by Reduced-Intensity Total Body Radiation Therapy and Donor Hematopoietic Cell Transplant for the Treatment of Adults Age 60 and Older With Newly Diagnosed Adverse-Risk Acute Myeloid Leukemia or Other High-Grade Myeloid Cancer | 2027-06-30 |
Add all 2 to your calendar (.ics) → With an account.
Among the 60 studies testing cytarabine in Myelodysplastic Syndromes, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Peking University People's Hospital’s 12 in Myelodysplastic Syndromes:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This study aimed to evaluate the efficacy of reduced intensity conditioning (RIC) regimen in elderly or high comorbidity burden patients who receive haploidentical hematopoietic stem cell transplantation (haplo-HSCT). Haplo-HSCT is an effective treatment option for patients who did not have identical sibling donor (ISD) or unrelated donor (URD). However, post-transplant transplant-related mortality (TRM) is one of the major causes for transplant failure, and the risk of TRM for old patients or those with high comorbidity burden was higher. RIC regimen may decrease the risk of TRM for haplo-HSCT recipients. The study hypothesis: Using RIC haplo-HSCT regimen in elderly patients or those with high comorbidity burden can reduce TRM and improve survival.
RIC regimen was given for elderly patients or those with high comorbidity burden who would receive haplo-HSCT. The elderly patients were defined as older than 55 years. The burden of comorbidities in HSCT recipients was assessed based on the hematopoietic cell transplantation-specific comorbidity index (HCT-CI), and patients with score ≥3 were assigned as high burden. The primary end point was transplant-related mortality, and the secondary endpoints included overall survival, disease-free survival, relapse, engraftment, graft-versus-host disease (GVHD), and infections. Following time is 1 years.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Old patients or those have high comorbidity burden without identical sibling donor or unrelated donor would receive RIC haplo-HSCT. RIC preconditioning regimen consisted of cytarabine (2 g/m2/day, days -10 to -9), busulfan (3.2 mg/kg/day on days -8 to -6), cyclophosphamide (1.0 g/m2/day, days -5 to -4), fludarabine (30 mg/m-2/day, days -6 to -2), semustine (250 mg/m-2, day -3), and rabbit antithymocyte globulin (thymoglobulin, 2.5 mg/kg/d, days -5 to -2; Sanofi, France).
Drug: Cytarabine
RIC preconditioning regimen consisted of cytarabine (2 g/m2/day, days -10 to -9), busulfan (3.2 mg/kg/day on days -8 to -6), cyclophosphamide (1.0 g/m2/day, days -5 to -4), fludarabine (30 mg/m-2/day, days -6 to -2), semustine (250 mg/m-2, day -3), and rabbit antithymocyte globulin (thymoglobulin, 2.5 mg/kg/d, days -5 to -2; Sanofi, France).
Also known as: Busulfan, Cyclophosphamide, Fludarabine, Semustine, Antithymocyte globulin
Transplant-related mortality
Death without disease progression or relapse
Time frame: Participants will be followed for an expected average of 1 years
Started Feb 2018 (actual). Primary completion is estimated for Sep 2025, 91 months after the start.
Of 227 non-industry phase 2 interventional studies under Myelodysplastic Syndromes, half reached primary completion within 76 months of starting (the median), counting those still running; a quarter within 44 and three quarters within 116. This study's planned 91 months is above that.
Counting every sponsor, half of 279 studies reached it within 66 months; a quarter within 40 and three quarters within 104.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Cytarabine
Peking University People's Hospital →