St. Jude Clinical Trials
AML16: Epigenetic Priming in Patients with Acute Myeloid Leukemia
Phase II Trial of Epigenetic Priming in Patients with Newly Diagnosed Acute Myeloid Leukemia
Diseases Treated:
Eligibility:
- Diagnosis of one of the following:
- Acute myeloid leukemia (AML)
- 5% to 20% marrow myeloblasts and evidence of a clonal de novo AML genetic abnormality
- Myeloid sarcoma
- High grade myelodysplastic syndrome (MDS) with greater than 5% blasts
- Treatment-related myeloid neoplasms, including AML and MDS
- 28 days to 21 years old
- No prior therapy, except for one dose of intrathecal therapy and the use of hydroxyurea or low-dose cytarabine
- Not pregnant
CATCHAML: CAR T-Cell Therapy for Acute Myelogenous Leukemia (AML)
CATCHAML: CD123-Directed Autologous T-Cell Therapy for Acute Myelogenous Leukemia
Diseases Treated:
Acute Myelogenous Leukemia
Eligibility:
- 21 years old or younger
- Relapsed/refractory CD123+ AML, B-ALL, T-ALL or blastic plasmacytoid dendritic cell neoplasm
- Has a suitable bone marrow transplant donor for allogeneic bone marrow transplant
HAP2HCT: Partially Matched Family Donor Bone Marrow Transplant in Children and Young Adults with High Risk Cancer
TCRαβ-depleted Progenitor Cell Graft with Additional Memory T-Cell DLI, plus Selected Use of Blinatumomab, in Naïve T-Cell depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies
Diseases Treated:
- Acute lymphoblastic leukemia
- Acute myeloid leukemia
- Myelodysplasia
- Hodgkin lymphoma
- Non-Hodgkin lymphoma
- Juvenile myelomonocytic leukemia
Eligibility:
For transplant recipient:
- 21 years or younger
- Does not have a suitable sibling donor or volunteer unrelated donor
- Has a suitable single haplotype matched family member donor
- Diagnosed with high risk hematologic malignancy
- No prior allogeneic hematopoietic cell transplant
HAPNK1: Blood and Marrow Transplant (BMT) for Children with Leukemia/Lymphoma
Haploidentical Donor Hematopoietic Progenitor Cell and Natural Killer Cell Transplantation with a TLI-Based Conditioning Regimen in Patients with Hematologic Malignancies
Diseases Treated:
Eligibility:
- 21 years and younger
- Does not have a suitable HLA-matched sibling donor or volunteer HLA-matched unrelated donor or is not a candidate for conventional matched donor transplant due to refractory disease
- Has a suitable single haplotype-matched family member donor
- High-risk hematologic malignancy, including certain diagnoses of:
- Acute lymphoblastic leukemia (ALL)
- Acute myeloid leukemia (AML)
- Chronic myelogenous leukemia (CML)
- Myelodysplastic syndrome (MDS)
- Hodgkin lymphoma
- Non-Hodgkin lymphoma
INOMRD: Inotuzumab Ozogamicin for Children with High-Risk B-Cell ALL
Inotuzumab Ozogamicin for Children with MRD Positive CD22+ Acute Lymphoblastic Leukemia
Diseases Treated:
Eligibility:
- Younger than 22 years old
- Diagnosis of B-cell acute lymphoblastic leukemia (B-ALL) with minimal residual disease (MRD) between 0.1 and 4.99% after prior chemotherapy, relapse or stem cell transplant
MEMCAR19: Allogeneic CAR T-Cell Therapy for Relapsed/Refractory CD19-Positive Leukemia
Phase I Study Evaluating Allogeneic Memory T Cells Engineered to Express Chimeric Antigen Receptors Specific for CD19 for the Treatment of Pediatric and Young Adult Patients with Relapsed or Refractory CD19-positive Leukemia
Diseases Treated:
Eligibility:
Donor eligibility includes:
- At least 18 years old
- At least single haplotype matched family member
Recipient eligibility includes:
- 21 years old or younger*
- Diagnosed with relapsed and/or refractory CD19-positive leukemia
- Not suitable for autologous CD19-CAR T-cell therapy
* Initial 3 participants must be at least 16 years old.
REF2HCT: Haploidentical Bone Marrow Transplant for Leukemia and Lymphoma
Provision of TCRγδ T Cells and Memory T Cells plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory despite Prior Transplantation
Diseases Treated:
Eligibility:
- 21 years old and younger
- Diagnosed with one of the following that has come back or did not improve after bone marrow transplant
- Acute lymphoblastic leukemia (ALL)
- Acute myeloid leukemia
- Myeloid sarcoma
- Chronic myeloid leukemia (CML)
- Juvenile myelomonocytic leukemia (JMML)
- Myelodysplastic syndrome (MDS)
- Non-Hodgkin lymphoma (NHL)
- Has a family member who is a suitable stem cell donor
SJBC3: Mature B-cell Lymphoma and Leukemia Study III
Risk-Adapted Therapy in Treating Young Patients with Mature B-Cell Lymphoma or Leukemia
Diseases Treated:
Eligibility:
- 21 years of age or younger
- Newly diagnosed mature B-cell non-Hodgkin lymphoma and leukemia
- No previous treatment (no more than 72 hours of steroids, one intrathecal chemotherapy treatment, and/or emergency radiation)
SJCAR19: CAR T-Cell Therapy for Children and Young Adults with Acute Lymphoblastic Leukemia
A Phase I/II Study Evaluating CD19-Specific CAR Engineered Autologous T-Cells in Pediatric and Young Adult Patients with Relapsed or Refractory CD19+ Acute Lymphoblastic Leukemia
Diseases Treated:
Eligibility:
- Children and young adults up to 21 years old
- Refractory or relapsed CD19+ acute lymphoblastic leukemia (ALL)
TOT17: Total Therapy for Children with Acute Lymphoblastic Leukemia and Lymphoma
Total Therapy Study 17 for Newly Diagnosed Patients with Acute Lymphoblastic Leukemia and Lymphoma
Diseases Treated:
Eligibility:
- Diagnosis of B-cell or T-cell acute lymphoblastic leukemia (ALL) or acute lymphoblastic lymphoma (LLy)
- 1 to 18 years old
- No prior therapy or limited prior therapy
VENAML: Chemotherapy Combined with Venetoclax in Children with Refractory or Relapsed Acute Myeloid Leukemia
A Phase I and Expansion Cohort Study of Venetoclax in Combination with Chemotherapy in Pediatric Patients with Refractory or Relapsed Acute Myeloid Leukemia
Diseases Treated:
Acute myeloid leukemia (AML), acute undifferentiated leukemia, mixed phenotype acute leukemia
Eligibility:
- Diagnosis of relapsed or refractory acute myeloid leukemia (AML), acute undifferentiated leukemia or mixed phenotype acute leukemia
- At least 2 years old and younger than 22 years old
- Recovered from acute effects of prior therapy and no evidence of graft-versus-host disease (GVHD)
- Adequate liver, kidney and heart functions
Collaborative Clinical Trials
cHOD17: Risk-Adapted Therapy for Children and Young Adults with Hodgkin Lymphoma
Pediatric Classical Hodgkin Lymphoma Consortium Study
Diseases Treated:
Eligibility:
- Previously untreated CD30+ classical Hodgkin lymphoma
- 21 years or younger at time of diagnosis (low-risk and intermediate-risk patients)
- 25 years or younger (high-risk patients)
PEPN1812 : Study of Flotetuzumab in Children with Relapsed or Refractory Acute Myeloid Leukemia
Phase I Trial of Flotetuzumab, a CD123 X CD3 Dual Affinity Re-Targeting (DART) Molecule, in Pediatric Patients with Relapsed/Refractory AML
Diseases Treated:
Eligibility:
- Younger than 21 years of age
- Diagnosed with recurrent or refractory acute myeloid leukemia (AML)
- Weigh more than 17kg
- Fully recovered from the acute toxic effects of all prior anti-cancer therapy