This study is NOT currently recruiting participants.
Number
02-H-0250
Sponsoring Institute
National Heart, Lung and Blood Institute (NHLBI)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 18 Years Max Age: 100 Years
Referral Letter Required
Yes
Population Exclusion(s)
Children
Keywords
Cutaneous T Cell Lymphoma; Peripheral Blood Stem Cell Transplant; Low Intensity Regimen
Recruitment Keyword(s)
Mycosis Fungoides; Sezary Syndrome; CTCL
Condition(s)
Mycosis Fungoides; Sezary Syndrome
Investigational Drug(s)
None
Investigational Device(s)
Intervention(s)
Other: A matched peripheral donor stem cells Drug: cyclosporine Drug: fludarabine Drug: Campath
Supporting Site
National Heart, Lung, and Blood Institute
Patients with advanced MF or SS who are between 18 and 70 years of age and have a matched family donor 18 years of age or older may be eligible for this study. Candidates will have a medical history, physical examination and blood tests, lung and heart function tests, X-rays of the chest, eye examination, and bone marrow sampling (withdrawal through a needle of about a tablespoon of marrow from the hip bone), and small skin biopsy (surgical removal of a piece of tissue for microscopic examination) or needle biopsy of the tumor.
Stem cells will be collected from both the patient and donor. To do this, the hormone G-CSF will be injected under the skin for several days to push stem cells out of the bone marrow into the bloodstream. Then, the stem cells will be collected by apheresis. In this procedure the blood is drawn through a needle placed in one arm and pumped into a machine where the required cells are separated out and removed. The rest of the blood is returned through a needle in the other arm.
Before the transplant, a central venous line (large plastic tube) is placed into a major vein. This tube can stay in the body and be used the entire treatment period to deliver the donated stem cells, give medications, transfuse blood, if needed, and withdraw blood samples. Several days before the transplant procedure, patients will start a conditioning regimen of low-dose chemotherapy with Campath 1H, fludarabine, and, if necessary, cyclophosphamide. When the conditioning therapy is completed, the stem cells will be infused over a period of up to 4 hours. To help prevent rejection of donor cells and GvHD, cyclosporine and mycophenolate mofetil will be given by mouth or by vein for about 3 months starting 4 days before the transplantation.
The anticipated hospital stay is 3 to 4 days, when the first 3 doses of Campath will be monitored for drug side effects. The rest of the procedures, including the transplant, can be done on an outpatient basis. Follow-up visits for the first 3 months after the transplant will be scheduled once or twice a week for a physical examination, blood tests and symptoms check. Then, visits will be scheduled at 6, 12, 18, 24, 30, 36, and 48 months post-transplant. Visits for the first 3 years will include blood tests, skin biopsies, and bone marrow biopsies.
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INCLUSION CRITERIA-RECIPIENT: Ages 18-70 years (both inclusive) Stages IIb to IVb patients with MF (biopsy diagnostic or consistent with MF) who have progressed despite at least one treatment regimen and all patients with SS AND Anticipated median survival less than 5 years or debilitation as a result of their disease. Recovery from acute toxicity of prior treatment for MF/SS (to less than or equal to grade 1 [CTCAE v3.0]) or stabilization of toxicity occurring from prior therapy for MF/SS. HIV negative ECOG performance status of 1 or less. No major organ dysfunction precluding transplantation. DLCO greater than or equal to 60 percent predicted Left ventricular ejection fraction greater than or equal to 40 percent. Less than or equal to 25 percent of liver involved with metastatic tumor by CT scan. 6/6 HLA matched family donor or 10/10 matched unrelated donor at the allelic level available Ability to comprehend the investigational nature of the study and provide informed consent. INCLUSION CRITERIA-RELATED and UNRELATED DONOR:<TAB> 6/6 HLA- matched family donor or 10/10 HLA-matched unrelated donor Age greater than or equal to 18 years Ability to comprehend the investigational nature of the study and provide informed consent. For unrelated donor, the NMDP unrelated donor inclusion criteria will be used as outlined in document (http://bethematch.org/WorkArea/DownloadAsset.aspx?id=1960). Donor eligibility will be completed per NMDP standards and in accordance with most recent and stringent FDA guidelines. EXCLUSION CRITERIA (ANY OF THE FOLLOWING)-RECIPIENT Patient pregnant or lactating Age greater than 70 or less than 18 years ECOG performance status of 2 or more. Psychiatric disorder or mental deficiency of the recipient or donor sufficiently severe as to make compliance with the BMT treatment unlikely and making informed consent impossible. Major anticipated illness or organ failure incompatible with survival from BMT and where survival is considered insufficient to assess transplant outcome (i.e. less than 3 months). DLCO less than 60 percent predicted Left ventricular ejection fraction less than 40 percent Serum creatinine greater than 2.0 mg/dl Serum bilirubin greater than 4 mg/dl, transaminases greater than 5 times the upper limit of normal HIV positive History of other malignancies in the last five years with the exception of basal cell or squamous cell carcinoma of the skin Evidence for CNS metastatic disease Disease involving greater than 25 percent of the liver radiographically. EXCLUSION CRITERIA (any of the following)-RELATED AND UNRELATED DONOR: Donor pregnant or lactating Age less than 18 years HIV positive (donors who are positive for hepatitis B (HBV), hepatitis C (HCV) or human T-cell lymphotropic virus (HTLV-1) will be used at the discretion of the investigator following counseling and approval from the recipient). Sickling hemoglobinopathy including HbSS or HbsC (for unrelated donors, testing for hemoglobinopathies will only be done when clinically indicated). History of malignancy within 5 years except basal cell or squamous carcinoma of the skin. Donor unfit to receive G-CSF and undergo apheresis (Uncontrolled hypertension, history of stroke, thrombocytopenia). Psychiatric disorder or mental deficiency of the donor sufficiently severe as to make compliance with the BMT treatment unlikely and making informed consent impossible.
Ages 18-70 years (both inclusive)
Stages IIb to IVb patients with MF (biopsy diagnostic or consistent with MF) who have progressed despite at least one treatment regimen and all patients with SS
AND
Anticipated median survival less than 5 years or debilitation as a result of their disease.
Recovery from acute toxicity of prior treatment for MF/SS (to less than or equal to grade 1 [CTCAE v3.0]) or stabilization of toxicity occurring from prior therapy for MF/SS.
HIV negative
ECOG performance status of 1 or less.
No major organ dysfunction precluding transplantation.
DLCO greater than or equal to 60 percent predicted
Left ventricular ejection fraction greater than or equal to 40 percent.
Less than or equal to 25 percent of liver involved with metastatic tumor by CT scan.
6/6 HLA matched family donor or 10/10 matched unrelated donor at the allelic level available
Ability to comprehend the investigational nature of the study and provide informed consent.
INCLUSION CRITERIA-RELATED and UNRELATED DONOR:<TAB>
6/6 HLA- matched family donor or 10/10 HLA-matched unrelated donor
Age greater than or equal to 18 years
For unrelated donor, the NMDP unrelated donor inclusion criteria will be used as outlined in document (http://bethematch.org/WorkArea/DownloadAsset.aspx?id=1960).
Donor eligibility will be completed per NMDP standards and in accordance with most recent and stringent FDA guidelines.
EXCLUSION CRITERIA (ANY OF THE FOLLOWING)-RECIPIENT
Patient pregnant or lactating
Age greater than 70 or less than 18 years
ECOG performance status of 2 or more.
Psychiatric disorder or mental deficiency of the recipient or donor sufficiently severe as to make compliance with the BMT treatment unlikely and making informed consent impossible.
Major anticipated illness or organ failure incompatible with survival from BMT and where survival is considered insufficient to assess transplant outcome (i.e. less than 3 months).
DLCO less than 60 percent predicted
Left ventricular ejection fraction less than 40 percent
Serum creatinine greater than 2.0 mg/dl
Serum bilirubin greater than 4 mg/dl, transaminases greater than 5 times the upper limit of normal
HIV positive
History of other malignancies in the last five years with the exception of basal cell or squamous cell carcinoma of the skin
Evidence for CNS metastatic disease
Disease involving greater than 25 percent of the liver radiographically.
EXCLUSION CRITERIA (any of the following)-RELATED AND UNRELATED DONOR:
Donor pregnant or lactating
Age less than 18 years
HIV positive (donors who are positive for hepatitis B (HBV), hepatitis C (HCV) or human T-cell lymphotropic virus (HTLV-1) will be used at the discretion of the investigator following counseling and approval from the recipient).
Sickling hemoglobinopathy including HbSS or HbsC (for unrelated donors, testing for hemoglobinopathies will only be done when clinically indicated).
History of malignancy within 5 years except basal cell or squamous carcinoma of the skin.
Donor unfit to receive G-CSF and undergo apheresis (Uncontrolled hypertension, history of stroke, thrombocytopenia).
Psychiatric disorder or mental deficiency of the donor sufficiently severe as to make compliance with the BMT treatment unlikely and making informed consent impossible.
Principal Investigator
Referral Contact
For more information: