Sirolimus, Cyclosporine, and Mycophenolate Mofetil in Preventing Graft-versus-Host Disease in Treating Patients With Blood Cancer Undergoing Donor Peripheral Blood Stem Cell Transplant
CompletedPhase 2Results postedLast updated 9 December 2019
What this trial tests
Phase 2 trial testing Allogeneic Hematopoietic Stem Cell Transplantation in Adult Acute Lymphoblastic Leukemia in 77 participants. Completed in 11 February 2019.
Eligibility, any sex, with Adult Acute Lymphoblastic Leukemia or Adult Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Patients With Grade II-IV Acute Graft Versus Host Disease (GVHD)Primary· 100 days post-transplant
Number of patients with grades II-IV acute GVHD
aGVHD Stages
Skin:
1. a maculopapular eruption involving \< 25% BSA
2. a maculopapular eruption involving 25 - 50% BSA
3. generalized erythroderma
4. generalized erythroderma w/ bullous formation and often w/ desquamation
Liver:
1. bilirubin 2.0 - 3.0 mg/100 mL
2. bilirubin 3 - 5.9 mg/100 mL
3. bilirubin 6 - 14.9 mg/100 mL
4. bilirubin \> 15 mg/100 mL
Gut:
Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe invo
Group
Value
95% CI
Class I Mismatch
15
Class II Mismatch
12
Number of Non-Relapse MortalitiesSecondary· 100 days post-transplant
Number of patients expired without disease progression/relapse.
Number of Patients With Grade III-IV Acute GVHDSecondary· 100 days post-transplant
Number of patients with grades III-IV acute GVHD
aGVHD Stages
Skin:
1. a maculopapular eruption involving \< 25% BSA
2. a maculopapular eruption involving 25 - 50% BSA
3. generalized erythroderma
4. generalized erythroderma w/ bullous formation and often w/ desquamation
Liver:
1. bilirubin 2.0 - 3.0 mg/100 mL
2. bilirubin 3 - 5.9 mg/100 mL
3. bilirubin 6 - 14.9 mg/100 mL
4. bilirubin \> 15 mg/100 mL
Gut:
Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe inv
Time frame: AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase II trial studies how well sirolimus, cyclosporine and mycophenolate mofetil works in preventing graft-vs-host disease (GVHD) in patients with blood cancer undergoing donor peripheral blood stem cell (PBSC) transplant. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving total-body irradiation together with sirolimus, cyclosporine, and mycophenolate mofetil before and after transplant may stop this from happening.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
Other trials of Allogeneic Hematopoietic Stem Cell Transplantation
Trials testing the same drug.
NCT06954987 — Venetoclax or Placebo in Combination With Reduced-Intensity Conditioning Hematopoietic Cell (Bone Marrow/Blood Stem Cell
· Phase 2
· not yet recruiting
NCT04579523 — ²¹¹At-OKT10-B10 and Fludarabine Alone or in Combination With Cyclophosphamide and Low-Dose TBI Before Donor Stem Cell Tr
· Phase 1
· not yet recruiting
NCT07349771 — Axatilimab Plus Standard of Care Therapy for the Prevention of Graft Versus Host Disease Following Allogeneic Hematopoie
· Phase 2
· not yet recruiting
NCT07500753 — A Single-arm, Prospective Study of a Clad-LABU Conditioning Regimen in HSCT for R/R MDS/AML in Elderly Patients
· NA
· recruiting
NCT07228624 — Ruxolitinib Before, During and After Hematopoietic Cell Transplant in Older Patients With Myelofibrosis and Myelodysplas
· Phase 2
· recruiting
Other recruiting trials for Adult Acute Lymphoblastic Leukemia
Currently open trials in the same condition.
NCT02159495 — Genetically Modified T-cell Immunotherapy in Treating Patients With Relapsed/Refractory Acute Myeloid Leukemia and Persi
· Phase 1
· active not recruiting
Other Fred Hutchinson Cancer Center trials
Trials by the same sponsor.
NCT07390968 — Self-Amplifying mRNA COVID-19 Vaccine (LUNAR-COV19) Versus Comirnaty Vaccine in Adult Hematopoietic Cell Transplant Pati
· Phase 2
· not yet recruiting
NCT07493252 — A Behavioral Application for Improving Smoking Cessation Among Smokers
· NA
· not yet recruiting
NCT07490860 — A Restorative Justice-Based Lung Cancer Screening Decision-Making Support Intervention Tailored for Black Individuals to
· NA
· not yet recruiting
NCT07194980 — Nemtabrutinib and Lisocabtagene Maraleucel for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small L
· Phase 2
· not yet recruiting
NCT07176000 — Tailored Patient Navigation to Improve the Uptake of Lung Cancer Screening in Tribal Communities in Western Washington S
· NA
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fred Hutchinson Cancer Center
Last refreshed: 9 December 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01251575.