A Phase 2 interventional study of anti-thymocyte globulin and busulfan in Graft Versus Host Disease, Leukemia and Lymphoma, sponsored by University of Nebraska. Completed at 1 site in United States. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by University of Nebraska · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
OUTLINE:
Patients undergo blood collection periodically during study for pharmacokinetic, pharmacogenomic, and other translational studies. Genomic DNA extracted from blood samples is analyzed by polymerase chain reaction for genetic polymorphisms in cyclophosphamide/busulfan disposition enzymes. Activated donor lymphocytes are assessed using flow cytometry to measure activation-induced cell death, as reflected by apoptosis in activated T cells. Chimerism on or around day 100 is also assessed using fluorescence in situ hybridization analysis and DNA fingerprinting.
After completion of study treatment, patients are followed periodically.
804 studies on the registry are indexed under Graft vs Host Disease; 149 are open to participants now.
This study's enrollment of 5 is below the median of 35 across 639 interventional studies indexed under Graft vs Host Disease.
Browse Graft vs Host Disease studies →University of Nebraska is the lead sponsor of 496 studies on the registry; 67 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 53 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
confirmed diagnosis of 1 of the following:
Available donor must meet the following criteria:
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.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
Biological: anti-thymocyte globulin · Drug: busulfan · Drug: cyclophosphamide · Drug: mycophenolate mofetil · Drug: tacrolimus · Genetic: polymerase chain reaction · Genetic: polymorphism analysis · Other: flow cytometry · Other: laboratory biomarker analysis · Other: pharmacogenomic studies · Other: pharmacological study · Procedure: allogeneic bone marrow transplantation · Procedure: allogeneic hematopoietic stem cell transplantation · Procedure: peripheral blood stem cell transplantation
Also known as: immunosuppressant
Also known as: Busulfex, Myleran
Also known as: cytophosphane
Also known as: CellCept
Also known as: Protopic, Envarsus XR, Astagraf XL
Transplantation-related Mortality at 100 Days Post-transplantation
Time frame: at the 100 days post-transplant
Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD)
Time frame: at day 100 post transplantation
Overall Survival
Time frame: 2 years post transplant
Event-free Survival
Time frame: 2 years post transplant
| Milestone | Unrelated Donor Allogeneic |
|---|---|
| Started | 5 |
| Completed | 3 |
| Not completed | 2 |
| Participants | Unrelated Donor Allogeneic |
|---|---|
| Transplantation-related Mortality at 100 Days Post-transplantation | 2 |
| Participants | Unrelated Donor Allogeneic |
|---|---|
| Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD) | 4 |
| Participants | Unrelated Donor Allogeneic |
|---|---|
| Overall Survival | 2 |
| Participants | Unrelated Donor Allogeneic |
|---|---|
| Event-free Survival | 2 |
Collected over Adverse events are collected from the time of consent until day plus 100 from transplant.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Unrelated Donor Allogeneic | 2/5 (40%) | 3/5 (60%) | 5/5 (100%) |
| Event | Unrelated Donor Allogeneic |
|---|---|
| Blood bilirubin increasedInvestigations | 1/5 |
| confusionPsychiatric disorders | 1/5 |
| Lung infectionInfections and infestations | 1/5 |
| Investigations - OtherInvestigations | 1/5 |
| Infections and infestations - OtherInfections and infestations | 1/5 |
| hyperglycemiaMetabolism and nutrition disorders | 1/5 |
| Event | Unrelated Donor Allogeneic |
|---|---|
| Febrile NeutropeniaBlood and lymphatic system disorders | 4/5 |
| HyperglycemiaMetabolism and nutrition disorders | 3/5 |
| Blood bilirubin increasedInvestigations | 3/5 |
| DiarrheaGastrointestinal disorders | 3/5 |
| FatigueGeneral disorders | 2/5 |
| Serum sicknessImmune system disorders | 2/5 |
| Renal and Urinary disorders - OtherRenal and urinary disorders | 2/5 |
| Platelet count decreasedInvestigations | 2/5 |
| HypoalbuminemiaMetabolism and nutrition disorders | 1/5 |
| Infections and infestations - OtherInfections and infestations | 1/5 |
| Age, Continuous(years) | Unrelated Donor Allogeneic |
|---|---|
| Mean | 50 (36 to 62) |
| Sex: Female, Male(Participants) | Unrelated Donor Allogeneic |
|---|---|
| Female | 1 |
| Male | 4 |
| Race/Ethnicity, Customized(Participants) | Unrelated Donor Allogeneic |
|---|---|
| Caucasian | 5 |
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Busulfan · Cyclophosphamide