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
18 Years
70 Years
Both
Lymphoma
Trial Information
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
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.
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.
PROJECTED ACCRUAL: A total of 9-58 patients will be accrued for this study.
Inclusion 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
PATIENT CHARACTERISTICS:
Age
- 18 to 70
Performance status
- ECOG 0-1
Life expectancy
- See Disease Characteristics
- At least 3 months
Hematopoietic
- Not specified
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
- LVEF at least 40%
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
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- At least 30 days since prior therapy for MF or SS
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Engraftment measured by donor-host chimerism in lymphoid and myeloid lines at days 15, 30, 45, 60, and 100
Safety Issue:
No
Principal Investigator
Ramaprasad Srinivasan, MD
Investigator Role:
Study Chair
Investigator Affiliation:
National Heart, Lung, and Blood Institute (NHLBI)
Authority:
Unspecified
Study ID:
CDR0000257524
NCT ID:
NCT00047060
Start Date:
July 2002
Completion Date:
Related Keywords:
- Lymphoma
- recurrent mycosis fungoides/Sezary syndrome
- stage II mycosis fungoides/Sezary syndrome
- stage III mycosis fungoides/Sezary syndrome
- stage IV mycosis fungoides/Sezary syndrome
- Lymphoma
- Mycoses
- Mycosis Fungoides
- Sezary Syndrome
Name | Location |
|---|---|
| NIH - Warren Grant Magnuson Clinical Center | Bethesda, Maryland 20892-1182 |
