Bulk Versus Fractionated Stem Cell Infusions in Patients With Hematologic Malignancies Undergoing Stem Cell Transplantation

This study is currently recruiting participants.
Verified March 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01596257
First received: May 9, 2012
Last updated: March 17, 2014
Last verified: March 2014

May 9, 2012
March 17, 2014
May 2012
May 2015   (final data collection date for primary outcome measure)
neutrophil recovery [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01596257 on ClinicalTrials.gov Archive Site
  • safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Toxicities will be graded on a scale of 0 to 4 as described by the NCI-Common Terminology for Adverse Events (CTCAE), version 4.0.
  • immune- reconstitution [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.
  • on bacterial, viral, and fungal infections during the first 100 days post transplant [ Time Frame: 100 days post days transplant ] [ Designated as safety issue: No ]
    The time to ALC 500, and the time to first bacterial, viral, and fungal infection will be computed using the cumulative incidence function and a comparison between groups will be undertaken using Gray's test.
  • hematopoietic function [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    Determine the effect of fractionated vs bulk CD34 selected stem cell infusions on hematopoietic function as determined by platelet counts and cumulative platelet transfusion requirements on days 30, 60 and 100, 6 and 12 months post transplant.
Same as current
Not Provided
Not Provided
 
Bulk Versus Fractionated Stem Cell Infusions in Patients With Hematologic Malignancies Undergoing Stem Cell Transplantation
Randomized Phase II Trial of Bulk Versus Fractionated Stem Cell Infusions in Patients With Hematologic Malignancies Undergoing Stem Cell Transplantation

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Leukemia
  • Procedure: allogeneic hematopoietic stem cell transplantation
    Undergo allogeneic hematopoietic stem cell transplant
  • Device: CliniMACS
  • Active Comparator: bulk SCT
    Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on day 0. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months
    Interventions:
    • Procedure: allogeneic hematopoietic stem cell transplantation
    • Device: CliniMACS
  • Experimental: fractionated SCT
    Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on days 0, 2, 4, and 6. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months
    Interventions:
    • Procedure: allogeneic hematopoietic stem cell transplantation
    • Device: CliniMACS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
May 2015
May 2015   (final data collection date for primary outcome measure)

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
  • 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
Both
up to 75 Years
Yes
Contact: Sergio Giralt, MD 212-639-6009
Contact: Richard O'Reilly, MD 212-639-5956
United States
 
NCT01596257
12-016
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Sergio Giralt, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP