Clinical trial NCT01158118
Conditions: Leukemia, Myeloid, Acute Myelodysplastic Syndromes Lymphoma, Non-Hodgkin Hodgkin Disease Leukemia, Lymphocytic, Chronic, B-Cell Multiple Myeloma
Keywords: Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Sponsor: Washington University School of Medicine
Start date: 2011-04-01; Completion date: 2016-12-31
Enrollment: 48 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will gather information about the combination the drugs plerixafor with sargramostim in donors of blood-forming cells (stem cells). These stem cells will be collected from the donor and transplanted into their sibling. The investigators believe that the two drugs together will provide enough stem cells for transplantation and may also reduce the risk of graft versus host disease.

Detailed description:
The main purpose of this study is to gather information about the combination the drugs plerixafor with sargramostim in donors of blood-forming cells (stem cells). Stem cells can be taken from the bone marrow of the pelvic bones or from the blood following treatment with drugs called growth factors; sargramostim is such a drug. Once stem cells leave the bone marrow and circulate in the blood, they are called peripheral blood stem cells (PBSCs). These cells can be collected through a routine procedure called apheresis, which involves placing two IVs into the arm which are connected to an apheresis machine; the machine then takes blood from the body, removes the stem cells, and returns the blood to the body.

Normally, a growth factor called filgrastim is given to donors in order to collect the stem cells used for transplantation. However, when stem cells collected using filgrastim are transplanted in patients, a possible unpredictable complication is graft versus host disease. It's thought that using a different growth factor such as sargramostim might reduce the occurrences of graft versus host disease in patients. However, sargramostim alone does not provide as many stem cells for transplantation as other growth factors. Plerixafor is another drug that can increase the number of PBSCs in a donor, but like with sargramostim, plerixafor alone does not always provide enough stem cells. This is why sargramostim and plerixafor are being combined in this study: the investigators believe that the two drugs together will provide enough stem cells for transplantation and may also reduce the risk of graft versus host disease.

Arms: arm 1: Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)

Day 5: Mobilization with 320 mcg/kg plerixafor IV

Day 5: Leukopheresis

If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6. arm 2: Conditioning Regimens

* fludarabine and busulfan +/- thymoglobulin
* fractionated total body irradiation and cyclophosphamide
* busulfan and cyclophosphamide
* single dose total body irradiation and cyclophosphamide

Day -2 = GvHD prophylaxis

Day 0 or +1 = PBSC transplant

Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day
Interventions: intervention 1: Sargramostim intervention 2: Plerixafor
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: