Allogeneic Transplantation
Leukemia Trials (AML & ALL)
COMIRB: 24-0685
A Multicenter, Open-label, Randomized, Phase 2 Study of Venetoclax and Azacitidine Plus Cusatuzumab Versus Venetoclax and Azacitidine Alone In Newly Diagnosed AML Patients Who Are Not Candidates for Intensive Therapy
Principal Investigator: Christine McMahon
Diagnosis of AML according to ICC 2022 (with the exclusion of MDS/AML with 10-19% blasts). Previously untreated AML except may have received emergency leukapheresis, hydroxyurea before study entry to control hyperleukocytosis. Deemed unfit for intensive therapy by meeting certain criteria (see details).
COMIRB: 24-1444
A Controlled Multi-Arm Phase 1 Umbrella Study Evaluating the Safety and Feasibility of T-Cell Receptor Engineered Donor T-Cells Targeting HA-1 (TSC-100) or HA-2 (TSC-101) in HLA-A*02:01 Positive Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation
PI: Mat Angelos
Eligibility: Undergoing allogeneic HCT for either of the following: • AML (including mixed phenotype acute leukemia) • MDS • ALL *See other eligibility details
COMIRB: 24-0178
Mitoxantrone for Venetoclax-Resistant Acute Myeloid Leukemia
PI: Andrew Kent
Eligibility: Ages ≥ 18; Subject must have confirmation of non-APL AML by WHO criteria and have been treated with first-line venetoclax/HMA (azacitidine or decitabine)
COMIRB: 23-0273
Study of cladribine+venetoclax After Failure of venetoclax+hypomethylating Agent in Monocytic AML
PI: Christine McMahon
Eligibility: Ages ≥ 18 years; R/R AML; ECOG of ≤2
COMIRB: 23-2063
Expanded Access Program for SNDX-5613 in Patients with Relapsed/Refractory Acute Leukemias with Genetic Alterations Associated with HOXA Overexpression
PI: Christine McMahon
Eligibility: acute leukemia; not eligible for participation in an ongoing clinical study and have no approved treatment options.
COMIRB: 23-0061
KO-MEN-007, Phase 1 Study of Venetoclax/Azacitidine or Venetoclax in Combination with Ziftomenib (KO-539) or Standard Induction Cytarabine/Daunorubicin (7+3) Chemotherapy in Combination with Ziftomenib for the Treatment of Patients with Acute Myeloid Leukemia
PI: Christine McMahon
Eligibility: Ages ≥ 18; documented NPM1 mutation or KMT2A rearrangement and have either newly diagnosed or relapsed/refractory AML; ECOG of ≤2
COMIRB: 20-2350
A Phase 1 Open-Label Study Of KPT-9274 In Patients with Relapsed or Refractory Acute Myeloid Leukemia
PI: Dan Pollyea
Eligibility: Ages ≥ 18 years; non-APL AML who have not responded to or relapsed after at least one prior therapy and for whom no standard therapy that may provide clinical benefit is available; ECOG of ≤ 2
COMIRB: 23-2210
Specialty Compared to Oncology Delivered Palliative Care for Patients with Acute Myeloid Leukemia “SCOPE – Leukemia”
Site PI: Stacy Fischer, MD
Eligibility: high risk AML patients based on the following inclusion criteria: • Newly diagnosed with AML at the age of 60 or greater • Antecedent hematologic disorder (prior blood disorder before AML diagnosis) • Therapy-related disease (radiation / chemotherapy for another cancer before AML diagnosis) • Relapse AML or primary refractory AML • Patient’s AML went into remission and came back • Patient received AML treatment and did not go into remission
COMIRB: 22-0054
Phase I Safety and Tolerability Trial of CD19 Directed CAR T Cells in Adult Patients with B-Cell Acute Lymphoblastic Leukemia (B-ALL) with Minimal Residual Disease (MRD) Positivity at First Complete Remission
PI: Marc Schwartz
Eligibility: Ages ≥ 18; B-cell ALL in first complete morphologic remission; MRD positive; ECOG of ≤2
COMIRB: 22-1502
Open Label Dose-escalation and Dose-expansion Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of UCART22 (Allogeneic Engineered T-cells Expressing Anti-CD22 Chimeric Antigen Receptor) in Patients With Relapsed or refractory CD22+ B-cell Acute Lymphoblastic Leukemia (B-ALL)
PI: Marc Schwartz
Eligibility: Ages ≥ 18 years; diagnosed R/R B-ALL; B-ALL blast expressing CD22; , ECOG of 0 or 1
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