Mismatched Family Member Donor Transplantation for Children and Young Adults With High Risk Hematological Malignancies
Leukemia, Acute Lymphocytic (ALL), Leukemia, Myeloid, Acute(AML), Leukemia, Myeloid, Chronic(CML)
About this trial
This is an interventional treatment trial for Leukemia, Acute Lymphocytic (ALL) focused on measuring Haploidentical stem cell transplant, Allogeneic stem cell transplant, Mismatched family member stem cell donor transplant, Bone marrow transplant, High risk hematologic malignancies, T cell depletion methodology, Miltenyi Biotec CliniMACS stem cell selection device, Campath-1H intravenous
Eligibility Criteria
Inclusion Criteria:(transplant recipient)
- Patients less than or equal to 21 years of age; may be greater than 21 years old if a current St. Jude patient or previously treated St. Jude patient within 3 years of completion of prior treatment.
Must have one of the following diagnosis:
- ALL high risk in second remission. Examples include relapse on therapy, first remission duration of less than or equal to 30 months, or relapse within 12 months of completing therapy.
- ALL in third or subsequent remission.
- ALL high risk in first remission. Examples include: induction failure, minimal residual disease greater than or equal to 1% marrow blasts by morphology after induction, persistent or recurrent cytogenetic or molecular evidence of disease during therapy requiring additional therapy after induction to achieve remission.
- High-risk AML in first remission. Examples include 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 (includes myeloid sarcoma).
- Relapsed or persistent AML (less than or equal to 25% blasts in marrow by morphology).
- AML in second or subsequent morphologic remission (includes myeloid sarcoma).
- CML in first chronic phase with detectable molecular or cytogenetic evidence of disease despite medical therapy; or CML with a history of accelerated or blast crisis, now in chronic phase; or unable to tolerate tyrosine kinase inhibitor therapy.
- Juvenile myelomonocytic leukemia (JMML).
- Myelodysplastic syndrome (MDS).
- Therapy related (secondary) AML, ALL, or MDS.
- Hodgkin lymphoma after failure of prior autologous HSCT or unsuitable for autologous HSCT.
- Non-Hodgkin lymphoma (NHL) in second complete remission (CR2) or subsequent.
- Has not received a prior allogeneic hematopoietic stem cell transplant.
- Does not have a suitable HLA-matched sibling donor available for stem cell donation.
- Does not have a suitable cord blood product or volunteer matched unrelated donor (MUD) available in the necessary time for stem cell donation.
- Has a suitable HLA partially matched family member available for stem cell donation.
- Cardiac shortening fraction greater than or equal to 25%.
- Creatinine clearance or glomerular filtration rate (GFR) greater than or equal to 40 ml/min/1.73 m^2.
- Forced vital capacity (FVC) greater than or equal to 40% of predicted value or a pulse oximetry value of greater than or equal to 92% on room air.
- Direct bilirubin less than or equal to 3 mg/dl.
- Age-dependent performance score of greater than or equal to 50.
- Serum glutamic pyruvic transaminase (SGPT) less than 3 times the upper limit of normal for age.
- Karnofsky or Lansky (age-dependent) performance score of greater than or equal to 50.
- No known allergy to murine products or human anti-mouse antibody (HAMA) results within normal limits.
- Not pregnant (confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment).
- Not breast feeding.
Inclusion criteria (stem cell donor):
- Partially HLA matched family member.
- At least 18 years of age.
- Human immunodeficiency virus (HIV) negative.
- Not pregnant (confirmed by negative serum or urine pregnancy test within 7 days prior to enrollment).
- Not breast feeding.
Inclusion criteria (transplant recipient - stem cell boost)
Has experienced one of the following disorders post-transplant:
- graft failure
- graft rejection
- delayed hematopoietic and/or immune reconstitution.
Exclusion: NA
Sites / Locations
- St. Jude Children's Research Hospital
Arms of the Study
Arm 1
Experimental
High-Risk Hematologic Malignancies
Participants meeting eligibility criteria undergo haploidentical stem cell transplantation along with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (after January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF. Grafts from suitable haploidentical donors are processed using the CliniMACS system.