Transplantation-related Mortality at 100 Days Post-transplantation
Primary
· at the 100 days post-transplant
| Group | Value | 95% CI |
|---|---|---|
| Unrelated Donor Allogeneic | 2 |
Last reviewed · How we verify
NCT00611351
Busulfan, Cyclophosphamide, & Antithymocyte Globulin Followed by Stem Cell Transplant in Treating Hematologic Cancer
Completed
Phase 2
Results posted
Last updated 23 October 2023
What this trial tests
Phase 2 trial testing anti-thymocyte globulin in Graft Versus Host Disease in 5 participants. Completed in 17 September 2008.
Timeline
7 June 2005
Primary endpoint
1 February 2008
1 February 2008
17 September 2008
Quick facts
| Lead sponsor | University of Nebraska |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 5 |
| Start date | 7 June 2005 |
| Primary completion | 1 February 2008 |
| Estimated completion | 17 September 2008 |
| Sites | 1 location across United States |
Drugs / interventions tested
- anti-thymocyte globulin
- busulfan — full drug profile →
- cyclophosphamide (cyclophosphamide) — full drug profile →
- mycophenolate mofetil (MYCOPHENOLATE MOFETIL) — full drug profile →
- tacrolimus (TACROLIMUS) — full drug profile →
- polymerase chain reaction
- polymorphism analysis
- flow cytometry
- laboratory biomarker analysis
- pharmacogenomic studies
- pharmacological study
- allogeneic bone marrow transplantation
- allogeneic hematopoietic stem cell transplantation
- peripheral blood stem cell transplantation
Conditions studied
- Graft Versus Host Disease — all drugs for Graft Versus Host Disease →
- Leukemia — all drugs for Leukemia →
- Lymphoma — all drugs for Lymphoma →
- Multiple Myeloma and Plasma Cell Neoplasm — all drugs for Multiple Myeloma and Plasma Cell Neoplasm →
Sponsor
University of Nebraska
Who can join
Adults 19 to 65, any sex, with Graft Versus Host Disease or 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.
Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD)
Secondary
· at day 100 post transplantation
| Group | Value | 95% CI |
|---|---|---|
| Unrelated Donor Allogeneic | 4 |
Overall Survival
Secondary
· 2 years post transplant
| Group | Value | 95% CI |
|---|---|---|
| Unrelated Donor Allogeneic | 2 |
Event-free Survival
Secondary
· 2 years post transplant
| Group | Value | 95% CI |
|---|---|---|
| Unrelated Donor Allogeneic | 2 |
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events are collected from the time of consent until day plus 100 from transplant.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Unrelated Donor Allogeneic
Serious: 3/5 (60%)
Deaths: 2/5
Serious adverse events (6 terms)
| Reaction | System | Unrelated Donor Allogeneic |
|---|---|---|
| Blood bilirubin increased | Investigations | — |
| confusion | Psychiatric disorders | — |
| Lung infection | Infections and infestations | — |
| Investigations - Other | Investigations | — |
| Infections and infestations - Other | Infections and infestations | — |
| hyperglycemia | Metabolism and nutrition disorders | — |
Other adverse events (25 terms — click to expand)
| Reaction | System | Unrelated Donor Allogeneic |
|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Blood bilirubin increased | Investigations | — |
| Diarrhea | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Serum sickness | Immune system disorders | — |
| Renal and Urinary disorders - Other | Renal and urinary disorders | — |
| Platelet count decreased | Investigations | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Infections and infestations - Other | Infections and infestations | — |
| Blood and lymphatic system - Other | Blood and lymphatic system disorders | — |
| syncope | Nervous system disorders | — |
| hypocalcemia | Metabolism and nutrition disorders | — |
| Encephalitis infection | Infections and infestations | — |
| Seizure | Nervous system disorders | — |
| nervous system - Other | Nervous system disorders | — |
| Anorexia | Metabolism and nutrition disorders | — |
| hypernatremia | Metabolism and nutrition disorders | — |
| anemia | Blood and lymphatic system disorders | — |
| acute coronary syndrome | Cardiac disorders | — |
| confusion | Psychiatric disorders | — |
| Encephalitis infection | Infections and infestations | — |
| Endocarditis infective | Infections and infestations | — |
| Neutrophil count decreased | Investigations | — |
| hyponatremia | Metabolism and nutrition disorders | — |
Most-reported serious reactions: Blood bilirubin increased, confusion, Lung infection, Investigations - Other, Infections and infestations - Other, hyperglycemia.
Data from ClinicalTrials.gov NCT00611351 adverse events section.
Sponsor's own description
RATIONALE: Giving chemotherapy before a donor bone marrow transplant or peripheral stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When certain 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 tacrolimus and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving busulfan together with cyclophosphamide and antithymocyte globulin followed by donor stem cell transplant works in treating patients with hematologic cancer.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00611351
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of anti-thymocyte globulin
Trials testing the same drug.
- NCT02122081 — Organ-Sparing Marrow-Targeted Irradiation Before Stem Cell Transplant in Treating Patients With High-Risk Hematologic Ma · Phase 1 · completed
- NCT02129582 — Targeted Marrow Irradiation, Fludarabine Phosphate, and Busulfan Before Donor Progenitor Cell Transplant in Treating Pat · Phase 1 · completed
- NCT02029638 — BMT and High Dose Post-Transplant Cyclophosphamide for Chimerism Induction and Renal Allograft Tolerance · Phase 2 · terminated
- NCT01598025 — Biparental HLA Haplotype Disparate T-cell Depleted Transplants for Patients Lacking an HLACompatible Donor · NA · terminated
- NCT00448201 — Reduced-Intensity Busulfan and Fludarabine With or Without Antithymocyte Globulin Followed by Donor Stem Cell Transplant · Phase 2 · completed
Other recruiting trials for Graft Versus Host Disease
Currently open trials in the same condition.
- NCT07356245 — Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma · Phase 2 · recruiting
- NCT07006506 — A Study of Belumosudil in People at Risk of Developing Graft-Versus-Host Disease After a Stem Cell Transplant · Phase 2 · recruiting
- NCT06815003 — Vedolizumab Plus Post-transplant Cyclophosphamide and Short Course Tacrolimus for the Prevention of Graft Versus Host Di · Phase 2 · recruiting
- NCT06705062 — Study Comparing Reduced Versus Standard Dose Post-transplantation Cyclophosphamide in Combination With Post-engraftment · Phase 3 · recruiting
- NCT06252870 — Study Testing Two Conditioning Regimen With a Single Prophylaxis of GVHD by Cyclophosphamide and Methotrexate Post-trans · Phase 2 · recruiting
Other University of Nebraska trials
Trials by the same sponsor.
- NCT07507006 — Feasibility Study of the Flash-Sole: A Wearable Midsole With Soft Actuators for Walking Assistance · NA · not yet recruiting
- NCT07517705 — MRD-Adapted Low-Dose Radiation Therapy During Frontline Chemoimmunotherapy for Diffuse Large B-Cell Lymphoma · NA · not yet recruiting
- NCT07506993 — Inflammation in Clear Aligners With and Without Attachments · not yet recruiting
- NCT07207850 — Parents Helping Parents for Youth Vaping Cessation · NA · not yet recruiting
- NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT00611351 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Nebraska
- Last refreshed: 23 October 2023
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/NCT00611351.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing