Allogeneic Transplantation From Related Haploidentical Donors
NCT ID: NCT00185692
Last Updated: 2019-12-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
16 participants
INTERVENTIONAL
2000-08-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Transplantation of CD34+ cells
Week #1: Total Lymphoid Inrradiation (TLI) 120 cGy + Anti-thymocyte Globulin (ATG) 1.5 mg/kg + Solumedrol 1.0 mg/kg Daily for 5 days.
Week #2: TLI 120 cGy (3 days a week, double on the 4th day) 5 days of CSP (oraly) one day after TLI was started. 3 days of MMF 4 days after TLI was started.
non-myeloablative hematopoietic cell transplantation
TLI and ATG infusion of the donor graft Post-transplant immunosuppression with cyclosporine and mycophenolate mofetil.
Anti-Thymocyte Globulin
1.5 mg/kg QD x 5, IV. Dosage will be based on body weight. Purified, sterile IgG fraction of immune serum of rabbits immumixied with human thymus lymphocyte. This drug acts to modify the number and function of lymphocytes.
Cyclosporine
6.25 mg/kg BID, PO.Mechanism of action is inhibition of T-cell activation by binding to a cytoplasmic protein (cyclophillin).
Mycophenolate Mofetil
15 mg/kg Q 8 hours, PO. Inhibtis the enzme inosine monophsophate dehydrogenase (MPDII) noncompetitively which blocks the de nobo synthesis of guanosine required for DNA synthesis and has an effect on T and B cells.
G-CSF
16 mg/kg, SQ Growth factor used to make bone marrow produce more blood cells
Solumedrol
1.0 mg/kg IV 2 hours prior to ATG Used to treat severe inflamation
Acetaminophen
650 mg PO, 30 minutes prior to infusion Pain reliever
Diphenydramine
50 mg IV, 30 minutes prior to infusion Used to relieve allergy symptoms
Hydrocortisone
100 mg IV, 1 hour prior to infusion Used to relieve itching, redness and swelling of the skin
Interventions
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non-myeloablative hematopoietic cell transplantation
TLI and ATG infusion of the donor graft Post-transplant immunosuppression with cyclosporine and mycophenolate mofetil.
Anti-Thymocyte Globulin
1.5 mg/kg QD x 5, IV. Dosage will be based on body weight. Purified, sterile IgG fraction of immune serum of rabbits immumixied with human thymus lymphocyte. This drug acts to modify the number and function of lymphocytes.
Cyclosporine
6.25 mg/kg BID, PO.Mechanism of action is inhibition of T-cell activation by binding to a cytoplasmic protein (cyclophillin).
Mycophenolate Mofetil
15 mg/kg Q 8 hours, PO. Inhibtis the enzme inosine monophsophate dehydrogenase (MPDII) noncompetitively which blocks the de nobo synthesis of guanosine required for DNA synthesis and has an effect on T and B cells.
G-CSF
16 mg/kg, SQ Growth factor used to make bone marrow produce more blood cells
Solumedrol
1.0 mg/kg IV 2 hours prior to ATG Used to treat severe inflamation
Acetaminophen
650 mg PO, 30 minutes prior to infusion Pain reliever
Diphenydramine
50 mg IV, 30 minutes prior to infusion Used to relieve allergy symptoms
Hydrocortisone
100 mg IV, 1 hour prior to infusion Used to relieve itching, redness and swelling of the skin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* For patients ≤ 50 years of age with hematologic malignacies treatable with mixed chimera HCT who because of pre-exisiting medical conditions or prior therapy are considered to be at high risk for regimen-related toxicity associated with conventional transplants.
* Indolent advanced stage NHL, CLL, HD - Must have received and failed front-line therapy.
* Multiple myeloma (Stage II or III) - Must have received prior chemotherapy. Consolidation after prior autografting is permitted.
* AML/ALL - Must be in complete hematologic remission and have received cytotoxic chemotherapy at some stage before transplant. Patients with molecular or cytogenetic relapse will be accepted providing a donor is available. Patients with persistent or refractory disease will be considered on a case by case basis and transplants must be approved by the principal investigator.
* CML - Patients will be accepted in chronic or accelerated phase. Patients who have received prior autografts after high dose therapy or have undergone intensive chemotherapy for either peripheral blood stem cell mobilization or treatment of advanced CML may be enrolled provided they are in CR, chronic phase or accelerated phase.
* MDS - All patients with MDS will be eligible for this protocol, however, those patients with \>10% blasts will require chemotherapy to reduce the blast % to \< 10%.
* SAA - Patients with severe aplastic anemia who have failed front line therapy.
* A fully HLA-identical sibling donor is not available.
* A matched unrelated donor has not been identified.
* A haploidentical related donor is available who is in good health and does not have contraindications to donation.
Exclusion Criteria
* Uncontrolled CNS involvement with disease
* Fertile men
* Women unwilling to use contraceptive techniques during and for 12 months following treatment
* Females who are pregnant
* Cardiac function: ejection fraction \< 30% or cardiac failure requiring therapy
* Pulmonary: DLCO \< 40% predicted and/or receiving supplementary continuous oxygen
* Liver function abnormalities: elevation of bilirubin to \> 4 mg/dl and/or transaminases \> 3x the upper limit of normal. If hyperbilirubinemai is due to a known cause that will not increase the risks of transplant, than this upper limit may be exceeded.
* Renal: creatinine clearance \< 50 cc/min (24 hour urine collection)
* Karnofsky performance score \< 60%
* Patients with poorly controlled hypertension.
* Documented fungal disease that persists despite treatment
* HIV positive patients.
* Hepatitis B and C positive patients will be evaluated on a case by case basis
* 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.
12 Months
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Robert Lowsky
Associate Professor of Medicine
Principal Investigators
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Robert Lowsky
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University School of Medicine
Stanford, California, United States
Countries
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Other Identifiers
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75117
Identifier Type: OTHER
Identifier Source: secondary_id
BMT124
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-13371
Identifier Type: -
Identifier Source: org_study_id
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