A Phase 2 interventional study of busulfan and cyclophosphamide in Leukemia, Lymphoma and Multiple Myeloma and Plasma Cell Neoplasm, sponsored by Masonic Cancer Center, University of Minnesota. Completed at 1 site in United States. Open to participants aged Up to 55 Years. Per ClinicalTrials.gov, last updated 2020-12-09.
Sponsored by Masonic Cancer Center, University of Minnesota · Phase 2, Interventional, and Treatment
RATIONALE: Giving chemotherapy, such as cyclophosphamide and busulfan, and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells from bone marrow or umbilical cord blood may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving methotrexate and cyclosporine after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well a donor stem cell transplant works in treating patients with previously treated lymphoma, multiple myeloma, or chronic lymphocytic leukemia.
OBJECTIVES:
OUTLINE:
2,036 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 237 are open to participants now.
This study's enrollment of 6 is below the median of 39 across 1,603 interventional studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.
Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →Masonic Cancer Center, University of Minnesota is the lead sponsor of 286 studies on the registry; 35 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.
Compared within Leukemia, Lymphocytic, Chronic, B-Cell, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Leukemia. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Recipients will be \<55 years, will have satisfactory organ function (excluding bone marrow) and will have a activity assessment >90% and will have:
Recipients will fall under one of the following disease categories
Chronic lymphocytic leukemia -- must have all three:
Advanced non-Hodgkin's lymphoma(NHL).
Advanced Hodgkin's disease beyond PR2 (>CR3, >PR3).
Multiple Myeloma (>CR2, >PR2) or after initial therapy if no prior PR.
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.
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.
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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receiving total body irradiation, stem cell infusion (allogeneic)transplantation using unrelated or partially matched allogeneic marrow or cord blood donors, busulfan, and cyclophosphamide.
Drug: busulfan · Drug: cyclophosphamide · Biological: Stem cell infusion · Radiation: Total body irradiation
For those not eligible for total body irradiation: busulfan 4 mg/kg/day orally (1 mg/kg orally every 6 hrs) on Days -9 through -6.
Also known as: Busulfex
Cyclophosphamide 60 mg/kg/day on days -7 and -6. For patients not eligible for total body irradiation: cytoxan 50 mg/kg intravenously (IV) on days -5 through -2.
Also known as: Cytoxan
Infused on Day 0
Also known as: umbilical cord blood transplantation, hematopoietic stem cell transplantation, allogeneic transplantation, bone marrow transplantation
165 cGy morning and evening on days -4 through -1.
Also known as: TBI
Number of Participants With Engraftment Failure
Graft failure is defined as not accepting donated cells. The donated cells do not make the new white blood cells, red blood cells and platelets.
Time frame: 3 Months
Number of Participants With Neutrophil Engraftment
Time to 1st 3 consecutive days with absolute neutrophil count (ANC) \> 5 x 10\^8/L and percentage of patients with neutrophil recovery by day 42 (Cumulative incidence).
Time frame: Day 42
Number of Participants With Platelet Engraftment
Time to platelets \> 20,000 (first of 3 consecutive days) with no platelet transfusions for seven days and percentage of patients with platelet engraftment \>50,000 by day 100.
Time frame: Day 180
Number of Participants With Grade 3-4 Acute Graft-versus-host Disease
Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.
Time frame: Day 100
Number of Participants With Persistence Disease
the return of disease after its apparent recovery/cessation.
Time frame: 3 Years
Number of Participants With Relapse of Malignancy
the return of disease after its apparent recovery/cessation.
Time frame: 3 Years
Number of Participants With 1 Year Overall Survival
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate. Overall survival will be defined as time from date enrollment to date of death or censored at the date of last documented contact for patients still alive.
Time frame: 1 year
Number of Participants With 2 Year Overall Survival
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate. Overall survival will be defined as time from date enrollment to date of death or censored at the date of last documented contact for patients still alive.
Time frame: 2 year
Number of Participants With of Chronic GVHD.
Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host.
Time frame: 1 Year
| Milestone | Allogeneic Transplantation |
|---|---|
| Started | 6 |
| Completed | 6 |
| Not completed | 0 |
Graft failure is defined as not accepting donated cells. The donated cells do not make the new white blood cells, red blood cells and platelets.
| Participants | Allogeneic Transplantation |
|---|---|
| Number of Participants With Engraftment Failure | 1 |
Time to 1st 3 consecutive days with absolute neutrophil count (ANC) \> 5 x 10\^8/L and percentage of patients with neutrophil recovery by day 42 (Cumulative incidence).
| Participants | Allogeneic Transplantation |
|---|---|
| Number of Participants With Neutrophil Engraftment | 5 |
Time to platelets \> 20,000 (first of 3 consecutive days) with no platelet transfusions for seven days and percentage of patients with platelet engraftment \>50,000 by day 100.
| Participants | Allogeneic Transplantation |
|---|---|
| Number of Participants With Platelet Engraftment | 2 |
Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.
| Participants | Allogeneic Transplantation |
|---|---|
| Number of Participants With Grade 3-4 Acute Graft-versus-host Disease | 3 |
the return of disease after its apparent recovery/cessation.
| Participants | Allogeneic Transplantation |
|---|---|
| Number of Participants With Persistence Disease | 1 |
the return of disease after its apparent recovery/cessation.
| Participants | Allogeneic Transplantation |
|---|---|
| Number of Participants With Relapse of Malignancy | 1 |
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate. Overall survival will be defined as time from date enrollment to date of death or censored at the date of last documented contact for patients still alive.
| Participants | Allogeneic Transplantation |
|---|---|
| Number of Participants With 1 Year Overall Survival | 2 |
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate. Overall survival will be defined as time from date enrollment to date of death or censored at the date of last documented contact for patients still alive.
| Participants | Allogeneic Transplantation |
|---|---|
| Number of Participants With 2 Year Overall Survival | 1 |
Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host.
| Participants | Allogeneic Transplantation |
|---|---|
| Number of Participants With of Chronic GVHD. | 0 |
Collected over 5 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Allogeneic Transplantation | 6/6 (100%) | 3/6 (50%) | 6/6 (100%) |
| Event | Allogeneic Transplantation |
|---|---|
| DeathNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/6 |
| Primary graft failureInjury, poisoning and procedural complications | 1/6 |
| Event | Allogeneic Transplantation |
|---|---|
| Active MalignancyNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 5/6 |
| InfectionInfections and infestations | 5/6 |
| GI bleedingGastrointestinal disorders | 4/6 |
| HemolysisBlood and lymphatic system disorders | 4/6 |
| HypertensionVascular disorders | 4/6 |
| IntubationRespiratory, thoracic and mediastinal disorders | 4/6 |
| Renal failureRenal and urinary disorders | 4/6 |
| Abnormal bilirubinInfections and infestations | 3/6 |
| DialysisRenal and urinary disorders | 3/6 |
| PneumoniaInfections and infestations | 3/6 |
| Age, Categorical(Participants) | Allogeneic Transplantation |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 6 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Allogeneic Transplantation |
|---|---|
| Female | 3 |
| Male | 3 |
| Ethnicity (NIH/OMB)(Participants) | Allogeneic Transplantation |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 1 |
| Unknown or Not Reported | 5 |
| Race (NIH/OMB)(Participants) | Allogeneic Transplantation |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 5 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Allogeneic Transplantation |
|---|---|
| United States | 6 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Stem Cell
Leukemia, Lymphocytic, Chronic, B-Cell →
Masonic Cancer Center, University of Minnesota →