A Phase I Pediatric Study of a Plerixafor Containing Regimen In Second Allogeneic Stem Cell Transplantation
N/A
21 Years
Both
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Chronic Myeloid Leukemia, Myelodysplastic Syndrome, Non-Hodgkin's Lymphoma
Trial Information
A Phase I Pediatric Study of a Plerixafor Containing Regimen In Second Allogeneic Stem Cell Transplantation
This study will determine the following objectives:
1. To determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of
plerixafor in combination with fludarabine, thiotepa, and melphalan as a conditioning
regimen for children and young adults undergoing a second allogeneic stem cell
transplant (SCT) procedure.
2. The study determines the secondary objectives:
- To describe the pharmacokinetic properties of plerixafor in this study population
- To evaluate the content of leukemia cells in bone marrow and in blood before and
after exposure to plerixafor
- To evaluate key regulatory and effector T cell populations in bone marrow and in
blood before and after exposure to plerixafor
- To estimate the cumulative incidence of relapse and overall survival in study
participants at one year after this second transplant procedure
Inclusion Criteria:
- Age less than or equal to 21 years old.
- One of the following hematologic malignancies that has relapsed after prior
allogeneic hematopoietic stem cell transplantation:
- Acute lymphoblastic leukemia (ALL)
- Acute myeloid leukemia (AML)
- Myelodysplastic syndrome (MDS)
- Chronic myeloid leukemia (CML)
- Juvenile myelomonocytic leukemia (JMML)
- Non-Hodgkin's lymphoma (NHL) with evidence of bone marrow disease
- Has a suitable human leukocyte antigen (HLA) matched family member or unrelated donor
available for stem cell donation. A "matched" donor is defined as matching at 5/6 or
6/6 HLA loci.
- Does not have active central nervous system (CNS) malignancy (history of CNS disease
allowed).
- No prior neuromuscular dysfunction or all prior grade I-IV neuromuscular dysfunctions
have subsided > 4 weeks prior to enrollment.
- Cardiac shortening fraction greater than or equal to 25%.
- Creatinine clearance greater than or equal to 50 ml/min/1.73 m2
- Forced vital capacity (FVC) greater than or equal to 40% of predicted value or pulse
oximetry greater than or equal to 92% on room air.
- Karnofsky or Lansky (age-dependent) performance score of greater than or equal to 50
.
- Off all treatment for acute or chronic graft-versus-host disease (GVHD) for at least
7 days prior to the initiation of conditioning.
- Bilirubin less than or equal to 3 times the upper limit of normal for age.
- Alanine aminotransferase (ALT) less than or equal to 3.0 times the upper limit of
normal for age.
- White blood cell count of less than 50,000/mm3
- Not pregnant as confirmed by negative serum or urine pregnancy test within 14 days
prior to enrollment.
- Not lactating.
- All patients of childbearing potential must agree to use an effective birth control
method
Exclusion Criteria:
- Pregnant and lactating females are excluded from participation as the short and
long-term effects of the preparative agents and infusion on a fetus and a nursing
child through breast milk are not entirely known at this time.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the dose-limiting toxicity and maximum tolerated dose of plerixafor in combination with fludarabine, thiotepa and melphalan as a conditioning regimen for patients undergoing a second allogeneic transplant procedure.
Outcome Time Frame:
7 days post transplant
Safety Issue:
Yes
Principal Investigator
Ashok Srinivasan, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
St. Jude Children's Research Hospital
Authority:
United States: Food and Drug Administration
Study ID:
MOZBMT
NCT ID:
NCT01068301
Start Date:
May 2010
Completion Date:
October 2013
Related Keywords:
- Acute Lymphoblastic Leukemia
- Acute Myeloid Leukemia
- Chronic Myeloid Leukemia
- Myelodysplastic Syndrome
- Non-Hodgkin's Lymphoma
- Allogeneic Stem Cell transplantation
- Plerixafor
- Acute Lymphoblastic leukemia
- Acute Myeloid leukemia
- Chronic Myeloid leukemia
- Myelodysplastic Syndrome
- Non-Hodgkin's Lymphoma
- Other Leukemia
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Lymphoma
- Lymphoma, Non-Hodgkin
- Myelodysplastic Syndromes
- Preleukemia
Name | Location |
|---|---|
| St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
