Status:
COMPLETED
Stem Cell Transplantation as Immunotherapy for Hematologic Malignancies
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Leukemia
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
2-21 years
Phase:
PHASE2
Brief Summary
Blood and marrow stem cell transplant has improved the outcome for patients with high-risk hematologic malignancies. However, most patients do not have an appropriate HLA (immune type) matched sibling...
Detailed Description
Secondary outcome evaluations for this clinical study included the following: * To estimate one-year overall survival for research participants with high risk malignancies who receive a haploidentica...
Eligibility Criteria
Inclusion
- Eligible participants were assigned to one of two different strata dependent on diagnosis, disease status and/or past transplant experience. Both strata received the same intervention but will be followed and analyzed separately.
- Group A must have one of the following diagnosis
- Acute lymphoid leukemia (ALL) in second or subsequent remission or high risk in first remission
- Acute myeloid leukemia (AML) in remission or with ≤ 25% blasts in bone marrow
- Chronic myeloid leukemia (CML)
- Juvenile myelomonocytic leukemia (JMML)
- Myelodysplastic syndrome (MDS)
- Paroxysmal nocturnal hemoglobinuria (PNH)
- Hodgkin's (HD) or non-Hodgkin's lymphoma (NHL) in second or subsequent remission after autologous HSCT, or unable to have hematopoietic stem cells collected for autologous HSCT
- Group B must have one of the following refractory diagnosis (chemoresistant relapse or primary induction failure)
- Acute lymphoid leukemia (ALL)
- Acute myeloid leukemia (AML) ≥ 25% blast in bone marrow
- Secondary AML / MDS
- Chronic myeloid leukemia (CML) in accelerated phase or blast crisis
- Juvenile myelomonocytic leukemia (JMML)
- Myelodysplastic syndrome (MDS)
- Hodgkin's (HD) or non-Hodgkin's lymphoma (NHL) with residual disease followed by autologous HSCT or who have chemo-resistant disease
- Or patients who have undergone prior allogeneic HSCT or who have a co-morbid condition that in the medical opinion of the Transplant Faculty makes standard myeloablation prohibited
- At least 2 and less than or equal to 21 years of age
- Lacks suitable HLA-identical sibling or matched available unrelated donor and has a mismatched family member donor that is available, HIV negative and at least 18 years old
- Cardiac shortening fraction ≥ 25%
- Creatinine clearance ≥ 40 cc/min/1.73m\^2
- FVC ≥ 40% of predicted or pulse oximetry ≥ 92% on room air
- Direct bilirubin ≤ 3 mg/dL or SGPT ≤ 500 U/L
- Karnofsky or Lansky (age dependent) performance score of ≥ 50
Exclusion
- Known allergy to murine products
- Lactating (female patient)
- Pregnancy (female patient)
- Active central nervous system (CNS) leukemia
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00143559
Start Date
August 1 2005
End Date
January 1 2009
Last Update
January 29 2009
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105