Status:
COMPLETED
T Cell Depletion for Recipients of HLA Haploidentical Related Donor Stem Cell Grafts
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Center for Cell and Gene Therapy, Baylor College of Medicine
The Methodist Hospital Research Institute
Conditions:
Acute Lymphoblastic Leukemia
Non Hodgkins Lymphoma
Eligibility:
All Genders
Up to 55 years
Phase:
PHASE2
Brief Summary
Subjects are being asked to participate in this study because treatment of their disease requires them to receive a stem cell transplant. Stem cells or "mother" cells are the source of normal blood ce...
Detailed Description
To participate in this study, the subject will need to have a central line (a thin plastic catheter or tube that is placed during surgery into one of the large veins in the neck or chest). Also befor...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Lack of suitable conventional donor (i.e. 5/6 or 6/6 related or 5/6 or 6/6 unrelated donor) or presence of a rapidly progressive disease not permitting time to identify an unrelated donor
- Age less than or equal to 55 years of age
- Patients with high risk ALL in CR1 or ALL or high grade (stage III or IV) NHL after first relapse or with primary refractory disease or minimal residual diseases.
- Myelodysplastic syndrome
- Patients with high risk AML in CR1 or after first relapse or with primary refractory disease or minimal residual disease.
- CML
- Hemophagocytic lymphohistiocytosis (HLH), familial hemophagocytic lymphohistiocytosis (FLH), viral-associated hemophagocytic syndrome (VAHS), X-linked lymphoproliferative disease (XLP), Severe chronic active Epstein Barr virus infection (SCAEBV) with predilection for T- or NK-cell malignancy
- Donor cells should be collected and frozen before conditioning starts
- EXCLUSION CRITERIA:
- Patients with a life expectancy (\< / = 6 weeks) limited by diseases other than leukemia
- Patients with symptomatic cardiac disease, or evidence of significant cardiac disease by echocardiogram (i.e., shortening fraction \< 25%)
- Patients with severe renal disease (i.e., creatinine clearance less than 40 cc/1.73 m\^2)
- Patients with pre-existing severe restrictive pulmonary disease (FVC less than 40% of predicted)
- Patients with severe hepatic disease (direct bilirubin greater than 3 ug/dl or SGPT (serum glutamic-pyruvic transaminase) greater than 500 ug/dl)
- Patients with severe personality disorder or mental illness
- Patients with a severe infection that on evaluation by the Principal Investigator precludes ablative chemotherapy or successful transplantation
- Patients with documented HIV positivity
- 'High risk' ALL or AML refers to those acute leukemias identified by the presence of specific biologic features, which predict high likelihood of failure to conventional chemotherapy. As biologic features of high risk disease evolve with improvement of conventional chemotherapy, it is not practical to define this indication with any further specificity. Therefore, high risk AML/ALL will be determined by the primary physician.
Exclusion
Key Trial Info
Start Date :
April 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00368355
Start Date
April 1 2000
End Date
November 1 2016
Last Update
January 21 2020
Active Locations (2)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030
2
Texas Children's Hosptial
Houston, Texas, United States, 77030