Recruiting

Phase 1

Phase 2

Allogeneic TransplantationAllogeneic Transplantation for Pediatric Leukemias With Unrelated Donors

Sponsor:

Ann & Robert H Lurie Children's Hospital of Chicago

Code:

NCT00679536

Conditions

Leukemia

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

Busulfan

Fludarabine

Thymoglobulin

Total Body Irradiation

Study Details

Brief summary:

The study proposes the use of Fludarabine, Busulfan, Anti Thymocyte Globulin Rabbit (ATG) and Total Body Irradiation as a preparative regimen before hematopoietic stem cell transplant from unrelated donor peripheral blood stem cells (PBSC). The hypothesis states that the 100 day mortality after this type of transplant will be significantly below the accepted standards, which is about 30% for unrelated donors.

Conditions

Leukemia

Study ID

NCT00679536

Start date

May, 2008

Status verified date

Jan, 2014

Completion date

May, 2015

Anticipated

Primary completion date

May, 2015

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

Ages 0-21
AML in one of the following stages:

Having preceding myelodysplasia (MDS)
High Risk cytogenetics
Requiring > 2 cycles chemotherapy to obtain complete remission
High allelic ratio FLT3/ITD+,
Standard risk cytogenetics with positive MRD at end of Induction
Second or 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, defined as:

Ph+ ALL; or,
MLL rearrangement with slow early response \[defined as having M2 (5-25% blasts) or M3 (>25% blasts on bone marrow examination on Day 14 of induction therapy)\]; or,
Hypodiploidy (< 44 chromosomes or DNA index < 0.81); or,
End of induction M3 bone marrow; or,
End of induction M2 marrow or MRD>1% with M2-3 marrow or MRD>1% at Day 42.
High-risk infant ALL defined as age <6 months at diagnosis with MLL (11q23) translocation.
High risk second remission, defined as:

Bone marrow relapse < 36 months from induction; or >36 mths if a matched sibling donor is available
T-lineage relapse at any time; or,
Very early isolated CNS relapse (<18 months from diagnosis); or,
Slow reinduction (M2-3 at Day 28) after relapse at any time.
Any third or 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 echocardiogram, or ejection fraction > 30% by radionuclide angiogram.
Adequate pulmonary function as defined by DLCO, FEV1/FVC > 60% by pulmonary function tests. For children who are uncooperative for PFTs and have no evidence of dyspnea at rest or exercise 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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: A

All patients on this trial will receive a conditioning regimen of Busulfan, Fludarabine, Anti-Thymocyte Globulin and Total Body Irradiation (400 cGy)

Interventions

Busulfan

Patient will receive a Test Dose of Busulfan on either Day -10 or Day -9. Patient will receive their Regimen Dose of Busulfan on Day -5 to Day -2. The regimen dose of Busulfan will be based off of the findings from their Test Dose.

Fludarabine

Patient will receive Fludarabine from Day -6 to Day -2. The dose of Fludarabine will be 30 mg/m\^2/day.

Thymoglobulin

The patient will also receive Thymoglobulin (rabbitATG) on Day -4 to Day -2. Each dose of rabbitATG will be 1.5 mg/kg/day.

Total Body Irradiation

On Day -1 the patient will receive a total of 400 cGy of Total Body Irradiation.

Primary 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. [ Time Frame: 100 day mortality ]

Central Contacts and Locations

Central contacts

Sonali Chaudhury, MD

312-227-4863 schaudhury@luriechildrens.org

Colleen E Rosen, BS, RN

312-227-4870 crosen@luriechildrens.org

Locations

Ann & Robert H. Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Sonali Chaudhury, MD

312-227-4863 schaudhury@luriechildrens.org

Colleen E Rosen, BS, RN

312-227-4870 crosen@luriechildrens.org

More Information

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Last update posted

Jan 23, 2014

Last verified

Jan, 2014

Keywords

Reduced Toxicity
Toxicity
Event Free Survival
Graft vs Host Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ann & Robert H Lurie Children's Hospital of Chicago on 2014-01-23.