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Allogeneic Transplantation for Pediatric Leukemias With Unrelated Donors Using Fludarabine, Busulfan, 400 cGy Total Body Irradiation, and Thymoglobulin


Phase 4
N/A
21 Years
Open (Enrolling)
Both
Leukemia

Thank you

Trial Information

Allogeneic Transplantation for Pediatric Leukemias With Unrelated Donors Using Fludarabine, Busulfan, 400 cGy Total Body Irradiation, and Thymoglobulin


The primary objective of this study is to evaluate the toxicity (as measured as 100 day
survival) after hematopoietic stem cell transplant from an unrelated donor with a novel
preparative regimen of Fludarabine, Busulfan, Anti-Thymocyte Globulin, and Total Body
Irratiation for pediatric patients with leukemia. The secondard objectives are to evaluate
the relapse-free and overall survival after hematopoietic stem cell transplant as well as to
evaluate the incidence of acute and chronic graft-versus-host disease after this prepartive
regimen.


Inclusion Criteria:



- Ages 0-21

- AML in one of the following stages:

- Having preceding myelodysplasia (MDS)

- High Risk cytogenetics

- Requiring > 2 cycles chemotherpay to obtain complete remission

- Second of greater CR

- First relapse with < 25% blasts in bone marrow

- With therapy-related AML whose prior malignancy has been in remission for at
least 12 months

- ALL in one of the following stages:

- High Risk First remission as defined as either Philadelphia + ALL or MLL
rearrangement with slow early response, or hypodilpoidy, or end of induction M3
bone marrow, or end of induction M2 with M2-3 at Day 41.

- High Risk Second remission as defined as either bone marrow relapse < 36 months
from induction, or T-lineage relapse at any time, or very early isolated CNS
relapse or slow induction after relapse at any time

- Any third of subsequent CR

- Biphenotypic or undifferentiated leukemia in any CR or if in first relapse must have
< 25% blasts in bone marrow

- MDS at any stage; prior therapies allowed

- CML in chronic or accelerated phase; prior therapies allowed

- Patient also must have the following organ requirements:

- Adequate renal function defined as serum creatinine <2x normal, or creatinine
clearance > 40 ml/min/m^2 or 70 ml/min.

- Adequate liver function as defined by total bilirubin less than or equal to 2
times normal and AST and ALT less than or equal to 4 times normal.

- Adequate cardiac function as defined by: shortening fraction > 24% by
echocardioagram, or ejection fraction > 30% by radionucline angiogram.

- Adequate pulmonary function as defined by DLCO, FEV1/FVC > 60% by pulmonary
function tests. For children who are uncooperative for PFTs ans have no evidence
of dyspnea at rest of ecercise intolerance, pulse oximetry > 94% on room air is
considered acceptable, with a normal chest xray.

- Adequate venous access; a double lumen central vascular access device or its
equivalent and an additional PICC line will be required for all patients.

- Women of childbearing potential and sexually active males should use effective
contraception while on study.

Exclusion Criteria:

- Inability to give informed consent or assent

- Inability to obtain a suitable donor

- Patient who is HIV-positive

- Patient who has active Hepatitis B

- Patient who is pregnant

- Patient who is otherwise considered unsuitable for transplant at the discretion of
the principal investigator.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the toxicity (as measures by 100 day survival) after hematopoietic stem cell transplant from an unrelated donor with a novel preparative regimen.

Outcome Time Frame:

100 day mortality

Safety Issue:

Yes

Principal Investigator

David A Jacobsohn, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ann & Robert H Lurie Children's Hospital of Chicago

Authority:

United States: Institutional Review Board

Study ID:

SCT 0208

NCT ID:

NCT00679536

Start Date:

May 2008

Completion Date:

May 2013

Related Keywords:

  • Leukemia
  • Reduced Toxicity
  • Toxicity
  • Event Free Survival
  • Graft vs Host Disease
  • Leukemia

Name

Location

Children's Memorial HospitalChicago, Illinois  60614