Status:
COMPLETED
Haploidentical Stem Cell Transplant for Treatment Refractory Hematological Malignancies
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Acute Lymphoblastic Leukemia (ALL)
Acute Myeloid Leukemia (AML)
Eligibility:
All Genders
2-21 years
Phase:
PHASE2
Brief Summary
Relapsed disease is the most common cause of death in children with hematological malignancies. Patients who fail high-intensity conventional chemotherapeutic regimens or relapse after stem cell trans...
Detailed Description
Secondary objectives for this protocol are to 1) assess the kinetics of lymphohematopoietic reconstitution and 2) describe the short and long-term (up to 5 years post- transplant) toxicity of haploide...
Eligibility Criteria
Inclusion
- 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
- Patients with a known allergy to murine products
- (Female Patients) Patient is pregnant
- Female Patients) Patient is lactating
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00145613
Start Date
June 1 2003
End Date
February 1 2009
Last Update
February 13 2009
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105