Allogeneic Transplantation for Pediatric Leukemias With Unrelated Donors

NCT00679536 | Unknown Phase 1 DMC

• 1 other identifier: SCT 0208
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Reduced Toxicity; Toxicity; Event Free Survival; Graft vs Host Disease

Outcome Measures

Primary Outcomes (1)

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

  100 day mortality

Secondary Outcomes (2)

• To evaluate the relapse-free and overall survival after hematopoietic stem cell transplant with Fludarabine/Busulfan/ATG/TBI preparative regimen for pediatric patients with leukemia.

  5 years

• To evaluate the incidence of acute and chronic graft-versus-host disease after hematopoietic stem cell transplant

  5 years

Study Arms (1)

A

EXPERIMENTAL

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

Drug: Busulfan; Drug: Fludarabine; Drug: Thymoglobulin; Radiation: Total Body Irradiation

Interventions

Busulfan DRUG

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.

Also known as: IV Busulfex

A

Fludarabine DRUG

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

Also known as: Fludara

A

Thymoglobulin DRUG

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

A

Total Body Irradiation RADIATION

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

A

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

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

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Leukemia; Graft vs Host Disease

Interventions

Busulfan; fludarabine; fludarabine phosphate; thymoglobulin; Whole-Body Irradiation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Radiotherapy; Therapeutics; Investigative Techniques

Study Officials

• Sonali Chaudhury, MD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonali Chaudhury, MD

CONTACT

312-227-4863; schaudhury@luriechildrens.org

Colleen E Rosen, BS, RN

CONTACT

312-227-4870; crosen@luriechildrens.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: May 15, 2008
• First Posted: May 19, 2008
• Study Start: May 1, 2008
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: January 23, 2014

Record last verified: 2014-01

Locations

US (1)