This study is NOT currently recruiting participants.
Number
17-H-0124
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: N/A
Referral Letter Required
No
Population Exclusion(s)
None
Keywords
Plerixafor; Leukapheresis; Mobilization; Stem Cells; Sickle Cell Disease
Recruitment Keyword(s)
Condition(s)
Sickle Cell Disease
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Drug: Plerixafor
Supporting Site
National Heart, Lung, and Blood Institute
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INCLUSION CRITERIA: -SCD patients who are 18 or older, and (a) planned to enroll in an active allogeneic HSCT study where back-up autologous HSCs are needed; OR (b) are eligible for an allogeneic HSCT study (i.e. have the same disease severity as group (a), but no active allogeneic HSCT study is available), and are willing to donate autologous HSCs for a future gene therapy, gene editing, or allogeneic HSCT study. -Adequate renal function: serum/plasma creatinine <1.5 mg/dL. -Adequate liver function: direct bilirubin and ALT <5 times the upper limit of normal range. -Blood counts: WBC >3,000/mm^3, granulocytes >1,000/mm^3, hemoglobin>7.0g/dL, platelets>150,000/mm^3. -Female patients of childbearing age should have a negative serum pregnancy test within one week of beginning plerixafor administration, have had a hysterectomy, post-menopausal, or absence of a menses for over a year. -Meets NIH Department of Transfusion Medicine (DTM) eligibility criteria for blood component donation for in vitro research use (negative serologic tests for syphilis, hepatitis B and C, HIV, and HTLV-1). -Ability to give informed consent to participate in the protocol. -Female and male individuals of reproductive potential must agree to one of the contraceptive regimens stated above if sexually active EXCLUSION CRITERIA: -Pregnancy. Female patients of childbearing age should have a negative serum pregnancy test within one week of beginning plerixafor administration, except those that have had a hysterectomy, post-menopausal, or an absence of a menses for over a year. -Active viral, bacterial, fungal, or parasitic infection. -History of cancer, excluding squamous carcinoma of the skin and cervical carcinoma in situ. -Active and painful splenomegaly or splenomegaly (size greater than upper limit of normal) determined by ultrasound. -Allergy to plerixafor.
-SCD patients who are 18 or older, and (a) planned to enroll in an active allogeneic HSCT study where back-up autologous HSCs are needed; OR (b) are eligible for an allogeneic HSCT study (i.e. have the same disease severity as group (a), but no active allogeneic HSCT study is available), and are willing to donate autologous HSCs for a future gene therapy, gene editing, or allogeneic HSCT study.
-Adequate renal function: serum/plasma creatinine <1.5 mg/dL.
-Adequate liver function: direct bilirubin and ALT <5 times the upper limit of normal range.
-Blood counts: WBC >3,000/mm^3, granulocytes >1,000/mm^3, hemoglobin>7.0g/dL, platelets>150,000/mm^3.
-Female patients of childbearing age should have a negative serum pregnancy test within one week of beginning plerixafor administration, have had a hysterectomy, post-menopausal, or absence of a menses for over a year.
-Meets NIH Department of Transfusion Medicine (DTM) eligibility criteria for blood component donation for in vitro research use (negative serologic tests for syphilis, hepatitis B and C, HIV, and HTLV-1).
-Ability to give informed consent to participate in the protocol.
-Female and male individuals of reproductive potential must agree to one of the contraceptive regimens stated above if sexually active
EXCLUSION CRITERIA:
-Pregnancy. Female patients of childbearing age should have a negative serum pregnancy test within one week of beginning plerixafor administration, except those that have had a hysterectomy, post-menopausal, or an absence of a menses for over a year.
-Active viral, bacterial, fungal, or parasitic infection.
-History of cancer, excluding squamous carcinoma of the skin and cervical carcinoma in situ.
-Active and painful splenomegaly or splenomegaly (size greater than upper limit of normal) determined by ultrasound.
-Allergy to plerixafor.
Principal Investigator
Referral Contact
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