Samuel Strober
Allogeneic Hematopoietic Cell Transplantation Using TLI/ATG for Older Patients with Hematologic Malignancies
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
To measure how frequently and to what degree a complication of transplant cell acute graft versus host disease (GV/HD) occurs.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Procedure: nonmyeloablative allogeneic hematopoietic cell transplant
Phase:
Phase 2Eligibility
Ages Eligible for Study:
Any Age to 70 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
A) Any patient with one of the following hematolymphoid malignancies or syndromes in whom allogeneic NST is warranted. Specific disease categories include: indolent advanced stage Non-Hodgkin Lymphomas, Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia, Hodgkin Disease, Acute Leukemias in complete remission, Aplastic Anemia, Paroxsymal Nocturnal Hemoglobinuria, and, Myelodysplastic and Myeloproliferative Syndromes. Patients with other selected malignancies/disorders may also be considered but must be approved by the transplant team and the Principal Investigator.
(B) Patient age > 50 years, or for patients <50 years of age but because of pre-existing medical conditions or prior therapy are considered to be at high risk for regimen-related toxicity associated with conventional myeloablative transplants.
(C) A fully HLA-identical sibling or matched unrelated donor is available. Patients with one antigen mismatched donors can be considered but only after discussion with the transplant team and the Principal Investigator.
(D) Patient must be competent to give consent.
Key Exclusion Criteria:
(A) Patients with progressive hematolymphoid malignancies despite conventional therapies, or acute leukemias not in complete remission.
(B) Uncontrolled CNS involvement with disease
(C) Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
(D) Females who are pregnant
(E) Organ dysfunction defined as follows:
- Cardiac function: ejection fraction <30% or uncontrolled cardiac failure
- Pulmonary: DLCO <40% predicted
- Liver function abnormalities: elevation of bilirubin to > 3 mg/dl and/or transaminases >4x the upper limit of normal
- Renal: creatinine clearance <50 cc/min (24 hour urine collection)
(F) Karnofsky performance score < 60%
(G) Patients with poorly controlled hypertension on multiple antihypertensives
(H) Documented fungal disease that is progressive despite treatment
(I) Viral infections: HIV positive patients. Hepatitis B and C positive patients will be evaluated on a case by case basis
(J) Psychiatric disorders or psychosocial problems which in the opinion of the primary physician or Principal Investigator would place the patient at unacceptable risk from this regimen.
Additional Study Details
Official Title:
Allogeneic Hematopoietic Cell Transplantation Using a Nonmyeloablative Preparative Regimen of Total Lymphoid Irradiation and Anti-Thymocyte Globulin for Older Patients with Hematologic MalignanciesAnticipated start date:
3/25/2003Lead Sponsor:
Stanford UniversityCollaborator(s):
- NIH
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- To measure how frequently and to what degree a complication of transplant cell acute graft versus host disease (GV/HD) occurs.
Secondary Outcomes:
- To evaluate the incidence and extent of chronic GVHD.
- To document the quantitative and qualitative reconstitution of the immune system including T cell subsets, NK cells and B cells.
- To evaluate the rate of relapse, overall and event-free survival and transplant related mortality rate.
- To evaluate the kinetics of donor hematopoietic cell engraftment and chimerism.
Total Number to be Enrolled:
250Total Number to be Enrolled at Stanford:
250More Information
Secondary ID(s):
- 78998
- BMT153
- NCT00185640
- PO1 CA49605
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
5/1/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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