- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00578942
Allo Non-myeloablative SCT Utilizing Matched Family Member Stem Cells Purged Using Campath
Allogeneic Non-myeloablative Stem Cell Transplantation Utilizing Matched Family Member Stem Cells Purged Using Campath-1H
Allogeneic transplantation is used to treat many malignant and non-malignant diseases, though the potential toxicities of the procedure remain high. We and others have shown that a less toxic preparative regimen allows reliable allogeneic engraftment for allogeneic transplantation.
The primary purpose of this treatment trial is to follow subjects undergoing allogeneic transplantation for long term outcomes. The regimen used has been tested in our prior phase I / II trial which has completed accrual. The issues of engraftment and rate of graft versus host disease have been answered and our success has led to this regimen being a standard approach for less toxic allogeneic therapy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Health Systems
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects must have their pathology reviewed and the diagnosis confirmed.
- Performance status must be Cancer and Leukemia Group B (CALGB) performance score 0, 1, or 2
- Subjects must have a 6/6 Human leukocyte antigen (HLA)-matched related donor who is evaluated and deemed able to provide peripheral blood progenitor cells (PBPC) and/or marrow by the transplant team.
- HIV antibody negative.
- Subjects must test negative serum beta-human chorionic gonadotropin (HCG) and must agree to use some form of adequate birth control during the periods they receive chemotherapy and any post-chemotherapy medications related to the transplant.
- Subjects must be >/=17 years of age
- Subjects must also have a resting multigated acquisition (MUGA) and/or ECHO and pulmonary function test (PFT) with diffusion capacity of lung (DLCO) performed before transplant and found to be acceptable according to the treating institution's guidelines. The required minimum standards include MUGA and/or ECHO showing an ejection fraction (EF) of 40% and PFTs showing DLCO of 40%. Those with an EF 40-50%, undergo cardiac evaluation and consultation. Also, those with DLCO 40-50%, undergo pulmonary evaluation and consultation.
- Specific populations for each disease category:
A) Hematologic malignancies Those with high risk or relapsed hematologic malignancy (including myeloid and lymphoid leukemias and lymphomas, myeloma or myelomatous like diseases, myeloproliferative disease, myelodysplasia). Those with good risk disease (first remission acute myeloid leukemia (AML) with inv 16 M4 Eos, M3 AML with t(15;17); or t(8;21) in first remission are not eligible).
B) Bone marrow failure
- Those specifically with idiopathic or secondary moderate, severe or very severe aplastic anemia (idiopathic or secondary) according to the accepted 'Camitta criteria' would be candidates.
- Those with diseases known to lead to severe marrow failure are eligible as well. These include those with myelofibrosis or paroxysmal nocturnal hemoglobinuria (PNH).
C) Solid Tumors Subjects must have had a biopsy confirming disease recurrence (metastases) at some point in their history, unless the patient presented with metastatic disease, in which case the initial primary site biopsy is adequate.
- Subjects with renal cell cancer, or melanoma will be eligible for this approach at this time. Subjects will have had documented metastatic disease at some time in the past. Subjects who are in remission or with residual disease after prior therapy for their metastatic disease are eligible, as there is no accepted cure for these patients with metastatic disease.
- Breast Cancer- Subjects will have had documented metastatic disease at some time in the past. Subjects who are in remission or with residual disease after prior therapy for their metastatic disease are eligible. Subjects must have failed at least one chemotherapy regimen for their metastatic disease and 1 hormonal agent if they are receptor positive.
Exclusion Criteria:
- pregnant or lactating women,
- patients with other major medical or psychiatric illnesses which the treating physician feels could seriously compromise tolerance to this protocol, and
- Leukemia patients in first remission with good risk cytogenetics for leukemia [t(15;17); t(8,22)]
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Campath Purged Non-myeloablative ASCT
Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors
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Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours. Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Toxicity
Time Frame: 1 year
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Acute graft versus host disease (GVHD) was graded according to the consensus criteria and NCI common terminology criteria for adverse events (CTCAE) v2.0 or 3.0 was used for all other toxicities.
Recognizing that acute GVHD pathology in the nonablative and donor lymphocyte infusion (DLI) setting may occur late, we tabulated skin, gut and liver toxicity consistent with acute GVHD (aGVHD) at anytime in the year following the infusion as aGVHD.
Toxicities were formally recorded for all patients twice weekly for the first 100 days, at each follow up visit, and as needed intercurrently.
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1 year
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Overall Survival (OS)
Time Frame: Up to 12 years; participants were followed for the duration of the study, an average of 8 years
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Estimate overall survival rates in subjects treated with a non-myeloablative preparative regimen followed by matched related allogeneic stem cells for allogeneic transplantation.
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Up to 12 years; participants were followed for the duration of the study, an average of 8 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response
Time Frame: 1 year
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Response Assessment included physical exam and evaluation of peripheral blood and bone marrow. There's no widely accepted criteria for response other than complete response (CR). CR for malignant hematologic diseases is met if all the following are met for >/= 1 month:
CR for solid tumors requires complete resolution of disease on physical exam and radiographs. CR for marrow failure is normal white cell, platelet and hematocrit values. |
1 year
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00008380
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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