Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT00047060
Eligibility Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00047060
Study Brief:
Protocol Section:
NCT00047060