Specialized Blood Cell Transplants for Cancers of the Blood and Bone Marrow
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|ClinicalTrials.gov Identifier: NCT00003838|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 7, 2020
The are a variety of cancerous diseases of the blood and bone marrow that can be potentially cured by bone marrow transplantation (BMT). Diseases like leukemia, lymphoma, and multiple myeloma are among the conditions that can be treated with BMT.
Some patients with these diseases can be treated with medical chemotherapy alone. However, patients who relapse following chemotherapy are usually not curable with additional chemotherapy treatments. The only option known to provide a potential cure if this occurs is BMT.
Allogenic transplants are cells collected from relatives of the patient. The transplant requires additional high intensity chemotherapy and radiation in order to destroy cancerous cells. In the process, many normal bone marrow cells are also destroyed. This is the reason for transplanting stem cells. The stem cells help to build new functioning bone marrow, red cells, white cells, and platelets. In addition, the immune cells from the donor are implanted into the recipient s body and help to fight off infection and kill remaining cancerous cells.
Unfortunately, the powerful doses of chemotherapy and radiation therapy associated with allogenic BMT have toxic side effects and often make BMTs too dangerous to attempt in many patients.
In order to reduce the complications of BMT, and make it a safer available option for patients with cancers of the blood and bone marrow, researchers have developed a new approach to the BMT.
In this study researchers plan to use stem cells collected from the blood stream of patient s relatives rather than from the bone marrow (blood progenitor/stem cell transplant). In addition, researchers plan to use low doses of chemotherapy and no radiation therapy to reduce side effects. The majority of the cancer killing effect will be the responsibility of the stem cell transplant rather than the chemotherapy.
|Condition or disease||Intervention/treatment||Phase|
|Myeloproliferative Disorders Acute Myelogenous Leukemia Chronic Myelogenous Leukemia Myelodysplastic Syndrome Acute Lymphoblastic Leukemia||Other: T-cell replete PBPC allograft||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||204 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Non-Myeloablative Allogeneic Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Hematologic Malignancies in High Risk Patients and in Patients With Debilitating Hematologic Diseases|
|Actual Study Start Date :||April 15, 1999|
|Actual Primary Completion Date :||December 14, 2018|
|Actual Study Completion Date :||June 18, 2020|
No Intervention: Donor
Subjects will receive a non-myeloablative preparative regimen of cyclophosphamide 60mg/kg/d x 2 days, and fludarabine 25mg /m2 intravenously (IV) over 30 minutes daily x 5 days followed by a PBPC graft targeted to deliver >5x10^6 CD34+ cells/kg
Other: T-cell replete PBPC allograft
Subjects will receive a non-myeloablative preparative regimen of cyclophosphamide 60mg/kg/d x 2 days, and fludarabine 25mg/m2 intravenously (IV) over 30 minutes daily x 5 days with or without ATG followed by a PBPC graft targeted to deliver >5x10^6 CD34+ cells /kg.
- Transplant related mortality at 200 days. [ Time Frame: 200 days ]Transplant related mortality at 200 days.
- Engraftment, degree of donor-host chimerism, incidence of acute and chronic graft vs. host disease, transplant related morbidity. [ Time Frame: Study End ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003838
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Richard W Childs, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|