Leukemia Clinical Trial
Official title:
Randomized Phase II Trial of Bulk Versus Fractionated Stem Cell Infusions in Patients With Hematologic Malignancies Undergoing Stem Cell Transplantation
NCT number | NCT01596257 |
Other study ID # | 12-016 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | May 5, 2012 |
Est. completion date | August 30, 2021 |
Verified date | August 2021 |
Source | Memorial Sloan Kettering Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 116 |
Est. completion date | August 30, 2021 |
Est. primary completion date | August 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 75 Years |
Eligibility | 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 ß-HCG) or breastfeeding. Women of childbearing age must avoid becoming pregnant while on the study |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Median Time to Engraftment of Neutrophils | Determine the effects of fractionated vs. bulk stem cell infusions on neutrophil recovery as defined by number of days with an absolute neutrophil count of less than 500 neutrophils per micro liter and time to an absolute neutrophil count (ANC) of 500. Determing the median time to ANC of >/= 0.5 x 10^9/L | Up to 100 weeks | |
Secondary | Number of Participants Assessed for Toxicities | Participants will be assessed for toxicities with the NCI-Common Terminology for Adverse Events (CTCAE), version 4.0. | 2 years | |
Secondary | Median Time to Platelet Engraftment | The area under the hematopoietic recovery curve for the factors: ALC, CD4, CD8, and platelet count. The area under the curve will be computed based on recordings at days 30, 60, 100, 180, 365. Determine days to platelet engraftment by platelet count. | Up to 365 days | |
Secondary | Overall Survival | Percentage of participants alive at 24 months | 24 months | |
Secondary | Hematopoietic Function on Day 30 | Determine the difference of CD4+ lymphocyte recovery between the two arms on day 30 | 30 days | |
Secondary | Hematopoietic Function on Day 180 | Determine the difference of CD4+ lymphocyte recovery between the two arms on day 180 | 180 days | |
Secondary | Hematopoietic Function on Day 360 | Determine the difference of CD4+ lymphocyte recovery between the two arms on day 360 | 360 days |
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