Status:
TERMINATED
Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Acute Lymphoblastic Leukemia (ALL)
Acute Myeloid Leukemia (AML)
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE2
Brief Summary
This pilot phase II trial studies how well a new reduced intensity conditioning regimen that includes haploidentical donor NK cells followed by the infusion of selectively T-cell depleted progenitor c...
Detailed Description
PRIMARY OBJECTIVE: * To estimate engraftment by day +42 post-transplant in patients who receive CD45RA-depleted haploidentical donor progenitor cell transplantation following reduced intensity condit...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age less than or equal to 21 years.
- One of the following hematologic malignancies that has relapsed or remains refractory after prior allogeneic hematopoietic cell transplant (HCT):
- ALL, AML, Myeloid Sarcoma, CML, Juvenile myelomonocytic leukemia (JMML), myelodysplastic syndrome (MDS), non-Hodgkin lymphoma (NHL)
- Has a suitable single haplotype matched (≥ 3 of 6) family member donor.
- Does not have any other active malignancy other than the one for which this transplant is indicated.
- If prior central nervous system (CNS) leukemia, it must be treated and in CNS complete remission (CR)
- Does not have current uncontrolled bacterial, fungal, or viral infection.
- Patient must fulfill pre-transplant evaluation:
- Left ventricular ejection fraction \> 40%, or shortening fraction ≥ 25%.
- Creatinine clearance (CrCl) or glomerular filtration rate (GFR) ≥ 50 ml/min/1.73m2.
- Forced vital capacity (FVC) ≥ 40% of predicted value; or pulse oximetry ≥ 92% on room air if patient is unable to perform pulmonary function testing.
- Karnofsky or Lansky (age-dependent) performance score ≥ 50 (See Appendix A).
- Bilirubin ≤ 3 times the upper limit of normal for age.
- Alanine aminotransferase (ALT) ≤ 5 times the upper limit of normal for age.
- Not pregnant. If female with child bearing potential, must be confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment.
- Not breast feeding
- DONOR: At least single haplotype matched (≥ 3 of 6) family member
- DONOR: At least 18 years of age.
- DONOR: HIV negative.
- DONOR: Not pregnant as confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment (if female).
- DONOR: Not breast feeding.
- DONOR: Regarding donation eligibility, is identified as either:
- Completed the process of donor eligibility determination as outlined in 21 CFR 1271 and agency guidance; OR
- Does not meet 21 CFR 1271 eligibility requirements, but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21 CFR 1271.
Exclusion
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02259348
Start Date
October 1 2014
End Date
March 1 2016
Last Update
May 30 2017
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105