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A Phase I Pediatric Study of a Plerixafor Containing Regimen In Second Allogeneic Stem Cell Transplantation


Phase 1
N/A
21 Years
Open (Enrolling)
Both
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Chronic Myeloid Leukemia, Myelodysplastic Syndrome, Non-Hodgkin's Lymphoma

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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