Bulk Versus Fractionated Stem Cell Infusions in Patients With Hematologic Malignancies Undergoing Stem Cell Transplantation
Conditions
Leukemia
Conditions: Keywords
CliniMACS-CD34 Reagent System, Acute Leukemia, Myelodysplastic syndrome, Non Hodgkins Lymphoma, Hodgkins Disease, Multiple Myeloma, 12-016
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: allogeneic hematopoietic stem cell transplantation Type: Procedure
Name: CliniMACS Type: Device
Overall Status
Recruiting
Summary
The purpose of this study is to find out if getting a blood stem cell transplant with donor stem cells given over several days is better than getting a blood stem cell transplant with donor stem cells given over 1 day. We want to find out which procedure over will result in improved recovery of blood and immune function after transplant. When donor stem cells are given over various days in mice, the blood and immune system recovery is quicker.
Detailed Description
This is a complex study that involves various interventions, Intervention #1: Donor Initial Stem Cell Collection; Intervention #2: Stem Cell Product Initial Processing Orders; Intervention #3 Patient Admission and Transplantation; Intervention #4: Stem cell infusion; Intervention #5: Post infusion follow up; Intervention #6: Off Study Patient and Donor Evaluation.

Patients whose donor fails to collect the appropriate number of cells will receive all their cells as a bulk infusion. These patients will continue to receive a transplant on protocol but will be replaced until both arms have reached the target accrual.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: 75 Years
Minimum Age: N/A
Gender: Both
Criteria: Inclusion Criteria:

- Patients who are considered candidates for an allogeneic stem cell transplantation as treatment for any of the following hematologic disorders:

- Acute Leukemia

- Myelodysplastic syndrome

- Other myeloproliferative disorder (i.e. myelofibrosis, chronic myelomonocytic leukemia, or chronic myelogenous leukemia)

- Non Hodgkins Lymphoma

- Hodgkins Disease

- Multiple Myeloma

- Age includes from birth to < 75 years old.

- Patients must have a Karnofsky (adult) or Lansky (pediatric) Performance Status > 70%

- Patients must have adequate organ function measured by:

- Cardiac: asymptomatic or if symptomatic then LVEF at rest must be > 40%

- Hepatic: < 5x ULN ALT and < 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia.

- Renal: serum creatinine <1.5 mg/dl or if serum creatinine is outside the normal range, then CrCl > 40 ml/min (measured or calculated/estimated)

- Pulmonary: asymptomatic or if symptomatic, DLCO > 40% of predicted (corrected for hemoglobin).

Exclusion Criteria:

- Female patients who are pregnant or breast-feeding.

- Active viral, bacterial or fungal infection

- Patient seropositive for HIV-I/II; HTLV -I/II

- Presence of leukemia in the CNS

- Candidate for a protocol of higher priority. For the purpose of this study, the following protocols will be considered of higher priority: 10-051

Donor Inclusion Criteria:

- HLA compatible related or unrelated donor, (i.e. a fully matched unmanipulated grafts or 1-2 HLA allele disparate donor for CD34 selected grafts).

- Meets criteria outlined in the FACT-approved SOP for "DONOR EVALUATION AND SELECTION FOR ALLOGENEIC TRANSPLANTATION" in the Blood and Marrow Transplant Program Manual, document E-1 see http://mskweb5.mskcc.org/intranet/html/80312.cfm

- Donor must have adequate peripheral venous catheter access for leukapheresis or must agree to placement of a central catheter.

- Wt >25kg

Donor Exclusion Criteria:

- Evidence of active infection (including urinary tract infection, or upper respiratory tract Infection) or viral hepatitis exposure (on screening), unless only HBS Ab+ and HBV DNA negative.

- Medical or physical reason which makes the donor unlikely to tolerate or cooperate with growth factor therapy and leukapheresis.

- Factors which place the donor at increased risk for complications from leukapheresis or GCSF therapy (e.g., autoimmune disease, sickle cell trait, symptomatic coronary artery disease requiring therapy).

- Pregnancy (positive serum or urine β-HCG) or breastfeeding. Women of childbearing age must avoid becoming pregnant while on the study
Location
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Sergio Giralt, MD - 212-639-6009
Start Date
May 2012
Completion Date
May 2016
Sponsors
Memorial Sloan Kettering Cancer Center
Source
Memorial Sloan Kettering Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page