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Phase I/II Study of Alemtuzumab-Based Conditioning Followed By HLA-Matched Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Advanced Mycosis Fungoides/Sezary Syndrome
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Registry Information
Alternate Title
Alemtuzumab Followed by Peripheral Stem Cell Transplantation in Treating
Patients With Advanced Mycosis Fungoides/Sezary Syndrome
Basic Trial Information
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Phase
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Status
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Protocol IDs
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Phase II, Phase I
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Treatment
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Active
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18 to 70
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NHLBI
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NHLBI-02-H-0250 NCT00047060
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Special Category:
NIH Clinical Center trial Objectives - Evaluate the ability of a conditioning regimen comprising alemtuzumab and fludarabine with or without cyclophosphamide to produce at least 80% sustained engraftment in patients with advanced mycosis fungoides/Sezary syndrome.
- Evaluate allogeneic graft-versus-tumor effects in mycosis fungoides/Sezary syndrome patients treated with a nonmyeloablative conditioning regimen followed by HLA-matched allogeneic peripheral blood stem cell transplantation.
- Determine the safety and toxicity of this regimen in these patients.
- Determine tumor response, disease-free survival, and overall survival of patients treated with this regimen.
- Determine the rate and extent of lymphocyte subset reconstitution in patients treated with this regimen.
- Determine transplant-related morbidity, including rates of acute and chronic graft-versus-host disease and infectious complications, and mortality in patients treated with this regimen.
Entry Criteria Disease Characteristics:
- One of the following diagnoses:
- Histologically confirmed mycosis fungoides (MF)
- Stage IIB, III, IVA, or IVB
- Progressive disease after at least 1 treatment regimen
- Sezary syndrome (SS)
- Clinically or radiographically evaluable disease
- Anticipated median survival of less than 5 years or debilitation as result of disease
- Less than 25% of liver involved with metastatic tumor by CT scan
- No CNS metastases by MRI
- 6/6 HLA-matched family donor available
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy Endocrine therapy Radiotherapy Surgery Other - At least 30 days since prior therapy for MF or SS
Patient Characteristics:
Age Performance status Life expectancy - See Disease Characteristics
- At least 3 months
Hematopoietic Hepatic - See Disease Characteristics
- Bilirubin no greater than 4 mg/dL
- Transaminases no greater than 5 times upper limit of normal
Renal - Creatinine no greater than 2 mg/dL
Cardiovascular Pulmonary - DLCO at least 60% of predicted
Other - HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- No major organ dysfunction or failure or major anticipated illness that would
preclude transplantation
- No psychiatric disorder or mental deficiency that would preclude study
- No other malignancy within the past 5 years except basal cell or squamous
cell skin cancer
Expected Enrollment 58A total of 9-58 patients will be accrued for this study. Outcomes Primary Outcome(s)Engraftment measured by donor-host chimerism in lymphoid and myeloid lines at days 15, 30, 45, 60, and 100 Response (complete [CR] and partial responses [PR] and stable [SD] or progressive disease [PD]) at days 30, 60, and 100
Secondary Outcome(s)Immune reconstitution measured by lymphocyte subset analysis and T cell repertoire at days 15, 30, 45, 60, and 100 Safety measured by incidence and severity of post-transplant complications
Outline Patients receive 1 of 2 nonmyeloablative conditioning regimens, depending on engraftment efficacy in prior patients. - Regimen A: Patients receive alemtuzumab IV over 2 hours on days -28, -27, -26, -24, -22, -19, -17, and -15 and fludarabine IV over 30 minutes on days -5 to -1.
- Regimen B: Patients receive alemtuzumab and fludarabine as in regimen A plus cyclophosphamide IV over 1 hour on days -7 and -6.
Patients also receive graft-versus-host disease prophylaxis comprising oral cyclosporine twice a day beginning on day -4 and continuing until day 100. Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. Donor T cell and myeloid chimerism will be evaluated and will guide decisions regarding donor lymphocyte infusions. Patients are followed every 2 months for 6 months, every 3 months for 1.5 years, and then every 6 months for 3 years.
Trial Contact Information
Trial Lead Organizations National Heart, Lung, and Blood Institute | | | Ramaprasad Srinivasan, MD, Protocol chair | | | | Trial Sites
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U.S.A. |
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Maryland |
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Bethesda |
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| | | | | | | | NIH - Warren Grant Magnuson Clinical Center |
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Registry Information | | Official Title | | A Phase I/II Study Of HLA-Matched Mobilized Peripheral Blood Hematopoetic Stem Cell Transplantation For Advanced Mycosis Fungoides/Sezary Using NonMyeloablative Conditioning With Campath-1H | | Trial Start Date | | 2002-07-30 | | Trial Completion Date | | 2012-12-28 (estimated) | | Registered in ClinicalTrials.gov | | NCT00047060 | | Date Submitted to PDQ | | 2002-08-09 | | Information Last Verified | | 2008-11-30 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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