Haploidentical Stem Cell Transplant for Treatment Refractory Hematological Malignancies

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00145613
• Date of registration: 01/09/2005
• Primary sponsor: St. Jude Children's Research Hospital
• Public title: Haploidentical Stem Cell Transplant for Treatment Refractory Hematological Malignancies
• Scientific title: Haploidentical Stem Cell Transplantation Utilizing T-Cell Depletion as Therapy for Patients With Refractory Hematological Malignancies
• Date of first enrolment: June 2003
• Target sample size: 25
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00145613
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Gregory Hale, M.D.
• Affiliation: St. Jude Children's Research Hospital

Key inclusion & exclusion criteria

Inclusion Criteria: Refractory hematological malignancies (chemoresistant relapse or
primary induction failure) including:

- Acute lymphoblastic leukemia (ALL), must have isolated or combined bone marrow
relapse or primary induction failure. Patients with extramedullary relapse are not
eligible unless they have previously received a stem cell transplant

- Acute myeloid leukemia (AML) >25% blasts in bone marrow

- Secondary AML

- Myelodysplastic syndrome (MDS)

- Secondary MDS

- Chronic myeloid leukemia (CML)

- Juvenile myelomonocytic leukemia (JMML)

- Paroxysmal nocturnal hemoglobinuria (PNH)

- Non-Hodgkin's lymphoma (NHL)*

- Hodgkin's Disease (HD)*

*Patients with lymphomas must have failed standard non-cross reactive combination
salvage chemotherapy with or without radiation therapy followed by autologous stem
cell transplant or patients with chemo resistant disease

- If patient has had previous stem cell transplant, must not be no earlier than 3
months from previous date of transplant

- Patients with shortening fraction greater than or equal to 25%

- Patients with creatinine clearance greater than or equal to 40cc/min/1.73m^2

- Patients with FVC greater than or equal to 40% of predicted, or pulse oximetry
greater than or equal to 92% on room air

- Patients with a performance score (Lansky/Karnofsky) of greater than or equal to 50

- Must have a suitable family member donor that is HIV negative, greater than or equal
to 18 years of age available for stem cell donation

Exclusion Criteria:

- Patients with a known allergy to murine products

- (Female Patients) Patient is pregnant

- Female Patients) Patient is lactating



Age minimum: 2 Years
Age maximum: 21 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Acute Lymphoblastic Leukemia (ALL)

Acute Myeloid Leukemia (AML)

Chronic Myeloid Leukemia

Hodgkin Disease

Juvenile Myelomonocytic Leukemia (JMML)

Lymphoma, Non-Hodgkin

Myelodysplastic Syndrome (MDS)

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Secondary AML

Secondary MDS

Intervention(s)

Device: Miltenyi Biotec CliniMACS

Drug: Systemic chemotherapy and antibodies

Procedure: Stem Cell Transplantation

Primary Outcome(s)

To ask in terms of one-year survival the efficacy of haploidentical stem cell transplantation in children with refractory hematological malignancies. [Time Frame: July 2006]

Secondary ID(s)

REFSCT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors