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KIR Favorable Mismatched Haplo Transplant for ALL/AML/MDS in Children

This study is looking at a type of stem cell transplant called haploidentical transplantation for children and young adults (up to 21 years old) with acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), or myelodysplastic syndromes (MDS). Researchers are using a special device called the CliniMacs TCR alpha-beta-Biotin system to prepare the transplant cells. They want to see if using donors with specific genetic markers (KIR2DL1 polymorphisms) can improve how long patients live without their disease returning. The study aims to enroll 50 participants and is currently unclear on its recruitment status.

Study design
This is a Phase II, open-label, non-randomized study. It plans to enroll 50 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure disease-free survival at 1 year after the transplant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02646839

KIR Favorable Mismatched Haplo Transplant and KIR Polymorphism in ALL/AML/MDS Allo-HCT Children

Enrolling by Invitation
PHASE2Up to 21InterventionalTreatment
Michael Pulsipher
~50 participants
Updated 2025-05-04 on ClinicalTrials.gov
What's tested:CliniMacs TCR alpha-beta-Biotin system

At a glance

Recruiting sites
0 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease free survival at 1 year post HCT
Measured over 1 year
+1 more outcome measured

Conditions

Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Myelodysplastic Syndromes

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NCT02646839

Where you'd take part

This study runs at 11 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Children's Hospital Los Angeles

    Los Angeles, Californiano site contact published

  • Children's Hospital Oakland

    Oakland, Californiano site contact published

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvaniano site contact published

  • Lurie Children's Hospital

    Chicago, Illinoisno site contact published

  • Medical College of Wisconsin

    Milwaukee, Wisconsinno site contact published

  • New York Medical Center

    Valhalla, New Yorkno site contact published

  • Rady Children's Hospital

    San Diego, Californiano site contact published

  • Stanford University Medical Center

    Palo Alto, Californiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Michael Pulsipher, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital Los Angeles

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

ALL high-risk in first remission (\<5% blasts by morphology pre-transplant) meeting criteria for transplant. Example CR1 indications: induction failure (\>5% blasts by morphology on post-induction BM), minimal residual disease greater than or equal to 1% marrow blasts by morphology after induction, minimal residual disease by flow cytometry \>0.01% after consolidation, hypodiploidy (\<44 chromosomes), persistent or recurrent cytogenetic or molecular evidence of disease during therapy requiring additional therapy after induction to achieve remission (e.g. persistent molecular BCR-ABL positivity).
ALL in second remission: B-cell; early (less than or equal to 36 months from initiation of therapy) BM relapse, late BM relapse with MRD \>0.1% by flow cytometry after first induction therapy; T-cell or Ph+ with BM relapse at any time; very early (less than 18 months from initiation of therapy) isolated extramedullary relapse (T or B-cell)
Myelodysplastic syndrome (MDS): Any 2001 WHO classification subtype (Appendix I). RAEB-2 patients may proceed directly to transplant, but may also receive induction chemotherapy before transplant. Patients with ≥20% morphologic marrow blasts will require induction therapy to reduce morphologic marrow blasts below 5% before transplant.
High-risk AML defined as monosomy 5, del 5q, monosomy 7, M6, M7, t(6;9), FLT3-ITD, or patients who have greater than or equal to 25% blasts by morphology after induction, or who do not achieve CR after 2 courses of therapy. Also, patients with ≥ 0.1% MRD or evidence of progressive extramedullary disease after induction chemotherapy.
AML in second or subsequent morphologic remission. 3. Has not received a prior allogeneic hematopoietic stem cell transplant. 4. Does not have a suitable HLA-matched sibling donor available for stem cell donation. 5. Does not have a suitable matched or single antigen mismatched related or unrelated donor available at any time (noted by search), or it is in the patient's best interest as judged by the attending to move forward with stem cell transplantation rather than wait for an unrelated donor to become available (refer to subsection 2.5.1 for further details). 6. Has a suitable HLA KIR favorable haploidentical matched family member available for stem cell donation. 7. Karnofsky Index or Lansky Play-Performance Scale ≥ 60 % on pre-transplant evaluation. Karnofsky scores must be used for patients \> 16 years of age and Lansky scores for patients \< 16 years of age. 8. Able to give informed consent if \> 18 years, or with a legal guardian capable of giving informed consent if \< 18 years. 9. Adequate organ function (within 4 weeks of initiation of preparative regimen), defined as:
Pulmonary: FEV1, FVC, and corrected DLCO must all be ≥ 50% of predicted by pulmonary function tests (PFTs). For children who are unable to perform for PFTs due to age, the criteria are: no evidence of dyspnea at rest and no need for supplemental oxygen.
Renal: Creatinine clearance or radioisotope GFR ³ 70 mL/min/1.73 m2 or a serum creatinine based on age/gender as follows:
Cardiac: Shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA) or ejection fraction of ≥ 50% by echocardiogram or radionuclide scan (MUGA), choice of test according to local standard of care.
Hepatic: \\SGOT (AST) or SGPT (ALT) \< 5 x upper limit of normal (ULN) for age. Conjugated bilirubin \< 2.5 mg/dL, unless attributable to Gilbert's Syndrome.

What this trial measures

  • Disease free survival at 1 year post HCT1 year
  • 1 yr disease free survival of patients transplanted with donors homozygous for KIR2DL1-C245 will be compared to patients with donors hetero- or homozygous for KIRD2DL1-R245 polymorphisms1 year