Safety and Efficacy of POL6326 for Mobilization/Transplant of Sibling Donor in Patients With Hema… (NCT01413568) | Clinical Trial Compass
CompletedPhase 1/2
Safety and Efficacy of POL6326 for Mobilization/Transplant of Sibling Donor in Patients With Hematologic Malignancies
United States38 participantsStarted 2012-04
Plain-language summary
Determine the safety and tolerability of POL6326 when used as a single mobilization agent.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Donor Inclusion Criteria
* Donor must be 18 to 70 years of age inclusive.
* Donor must be a 6/6 HLA-matched sibling willing to donate PBSC for transplant.
* Donor must have adequate cardiac function with no history of congestive heart failure and no history of atrial fibrillation or ventricular tachyarrhythmia.
* Donor must have adequate renal function as defined by a minimum creatinine clearance (CrCl) value of \>30 ml/min.
* Donor must have adequate hepatic function as defined by a total bilirubin \<3x upper limit of normal.
* Donor must have adequate neurologic function as defined by NO evidence of a severe central or peripheral neurologic abnormality and no history of cerebrovascular accident or seizure disorder requiring anticonvulsant medication.
* Donor must be HIV-1\&2 antibody and HTLV-1\&2 antibody sero-negative by FDA licensed test.
* Donor must have an ECOG performance status of 0 or 1.
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
* Donor must demonstrate ability to be compliant with study regimen.
* Donor must be able to understand and willing to sign an IRB approved written informed consent document.
Recipient Inclusion Criteria
* Recipient must have availa…
What they're measuring
1
Phase I Study - safety and tolerability of POL6326 as a mobilization agent.
Timeframe: 30 days
2
Phase II Study - determine the number of allogeneic donors who require a second leukapheresis