Improving Blood Stem Cell Collection and Transplant Procedures

Completed · Phase 1/Phase 2

Conditions studied: Myelodysplastic Syndrome (MDS), Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia, CML (Chronic Myelogenous Leukemia, CLL (Chronic Lymphocytic Leukemia)

In brief

Background: \- People who have some kinds of cancer can benefit from donated bone marrow stem cells. These stem cells help produce healthy bone marrow and slow or stop the spread of abnormal cells. However, stem cells transplants do not always work. Also, they may have serious side effects that can cause illness or death. The Bone Marrow Stem Cell Transplant Program is studying methods to make stem cell transplant procedures safer and more effective. Objectives: \- To test a new procedure that may improve the success and decrease the side effects of stem cell transplants. Eligibility: * Individuals 10 to 75 years of age who have a life-threatening illness that may require a stem cell transplant. * Healthy siblings who are able to provide stem cells for transplant. Design: * Participants will be screened with a medical history, physical exam, and blood and urine tests. * Donor procedures: * Stem cell donors will start by having apheresis to donate white blood cells. * Donors will receive filgrastim shots for 5 days to help move stem cells into the blood for collection. * Donors will have another round of apheresis to donate the stem cells for transplant. * Recipient procedures: * Before the transplant, recipients will have radiation twice a day for 3 days and chemotherapy for 7 days. * After the radiation and chemotherapy, recipients will receive the stem cells provided by the donor. * After the transplant, recipients will receive the white blood cells provided by the donor. * Recipients will be monitored closely for 4 months to study the success of the transplant. They will have more followup visits at least yearly thereafter. * Recipients will have a research apheresis prior to transplant and at 3 months.

Key facts

Study ID

NCT01517035

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

43

Starts

2012-01-13

Expected to finish

2017-03-29

Last updated by the study team

2018-07-05

Who can join

Age: 2 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• RECIPIENT (any of the following)
• Estimated probability of surviving less than three months
• Major anticipated illness or organ failure incompatible with survival from transplant
• Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the transplant treatment unlikely and making informed consent impossible.
• Positive pregnancy test for women of childbearing age.
• HIV positive
• DLCO adjusted for Hb and ventilation < 50% predicted
• Left ventricular ejection fraction < 40% (evaluated by ECHO) or < 30% (evaluated by MUGA)
• AST/SGOT > 10 times ULN (>grade 3, CTCAE)
• Bilirubin > 5 times ULN (>grade 3, CTCAE)
• Creatinine > 4.5 times ULN (>grade 3, CTCAE)
• Prior allogeneic stem cell transplantation
• DONOR (any of the following)
• Pregnant or breast-feeding. Lactating donors are permitted provided breastmilk is discarded during the days filgatrim (G-CSF) is given.
• Unfit to receive G-CSF and undergo apheresis (abnormal blood counts, history of stroke, uncontrolled hypertension)
• Sickling hemaglobinopathy including HbSS, HbAS, HbSC
• Donors who are positive for HIV active hepatitis B (HBV), hepatitis C (HCV) or human T-cell lymphotropic virus (HTLV-I/II)
• Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible.
• Age greater than or equal to 80 years old
• Children who weigh less than or equal to 18 kg and are < 2 years of age.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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