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Randomized Phase II Trial of Bulk Versus Fractionated Stem Cell Infusions in Patients With Hematologic Malignancies Undergoing Stem Cell Transplantation


Phase 2
N/A
75 Years
Open (Enrolling)
Both
Leukemia

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Trial Information

Randomized Phase II Trial of Bulk Versus Fractionated Stem Cell Infusions in Patients With Hematologic Malignancies Undergoing Stem Cell Transplantation


Inclusion Criteria:



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

- Acute Myeloid Leukemia

- Myelodysplastic syndrome

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

- Acute Lymphoblastic 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, 08-008.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

neutrophil recovery

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Sergio Giralt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

12-016

NCT ID:

NCT01596257

Start Date:

May 2012

Completion Date:

May 2014

Related Keywords:

  • Leukemia
  • CliniMACS-CD34 Reagent System
  • Acute Myeloid Leukemia
  • Myelodysplastic syndrome
  • Acute Lymphoblastic Leukemia
  • Non Hodgkins Lymphoma
  • Hodgkins Disease
  • Multiple Myeloma
  • 12-016
  • Leukemia
  • Hematologic Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021