An interventional study of allogeneic bone marrow transplantation and allogeneic hematopoietic stem cell transplantation in Chronic Myeloproliferative Disorders, Leukemia and Lymphoma, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged Up to 70 Years. Per ClinicalTrials.gov, last updated 2018-09-10.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and melphalan, before a donor peripheral stem cell transplant or bone marrow transplant helps stop the growth of cancer or abnormal cells. It also helps 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 tacrolimus, methotrexate, mycophenolate mofetil, and antithymocyte globulin before and after transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer or abnormal cells as not belonging in the patient's body and destroy them (graft-versus-tumor effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect.
PURPOSE: This phase II trial is studying how well donor stem cell transplant works in treating patients with hematologic cancer or other diseases.
OBJECTIVES:
Primary
Secondary
OUTLINE:
Quality of life is assessed at baseline.
After completion of study therapy, patients are followed every 3 months for 2 years and then every 6 months for up to 3 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 66 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Histologically confirmed hematological disease, including any of the following:
Chronic lymphocytic leukemia
Prolymphocytic leukemia
Non-Hodgkin's or Hodgkin's lymphoma
Multiple myeloma
Acute myeloid leukemia
Myelodysplastic syndromes
Polycythemia vera
Documented disease as defined by WHO criteria (i.e., A1 + A2, and any other category A, OR A1 + A2, and any 2 category B):
Chronic idiopathic myelofibrosis
HLA-identical sibling (6/6)
9/10 matched related donor
10/10 matched unrelated donor
Exclusion Criteria:
History of another malignancy*, meeting the following criteria:
Treatment-related Mortality Within the First 6 Months After Transplantation
Time frame: 6 months
Complete Response
Time frame: monthly
Overall Survival
Time frame: monthly
Disease-free Survival
Time frame: monthly
Graft-versus-host Disease
Time frame: monthly
Iron Status at the Time of Transplantation
Time frame: baseline
Quality of Life at the Time of Transplantation
Time frame: baseline
Treatment-related Mortality at 100 Days After Transplantation
Time frame: 100 days
| Milestone | Reduced Intensity Allogeneic Cell Transplantation |
|---|---|
| Started | 66 |
| Completed | 65 |
| Not completed | 1 |
| Withdrew: Death | 1 |
| participants | Reduced Intensity Allogeneic Cell Transplantation |
|---|---|
| Treatment-related Mortality Within the First 6 Months After Transplantation | 6 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over The only adverse events collected and analyzed for this study were grade 5 (death) related to transplant occurring within 6 months of transplant. No data was collected for less serious adverse events.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Reduced Intensity Allogeneic Cell Transplantation | — | 6/65 (9.2%) | 0/65 (0%) |
| Event | Reduced Intensity Allogeneic Cell Transplantation |
|---|---|
| Graft versus host diseaseImmune system disorders | 3/65 |
| Post transplant proliferative disorderImmune system disorders | 1/65 |
| Neurological unspecifiedNervous system disorders | 1/65 |
| Death of unknown causeGeneral disorders | 1/65 |
| Age, Continuous(years) | Reduced Intensity Allogeneic Cell Transplantation |
|---|---|
| Mean | 60.1 ± 7.5 |
| Age, Categorical(Participants) | Reduced Intensity Allogeneic Cell Transplantation |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 48 |
| >=65 years | 18 |
| Sex: Female, Male(Participants) | Reduced Intensity Allogeneic Cell Transplantation |
|---|---|
| Female | 21 |
| Male | 45 |
| Race (NIH/OMB)(Participants) | Reduced Intensity Allogeneic Cell Transplantation |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 64 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Ethnicity (NIH/OMB)(Participants) | Reduced Intensity Allogeneic Cell Transplantation |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 65 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Reduced Intensity Allogeneic Cell Transplantation |
|---|---|
| United States | 66 |
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Wake Forest University Health Sciences