Allogeneic Transplantation
Leukemia Trials (AML & ALL)
COMIRB: 24-0178
Mitoxantrone for Venetoclax-Resistant Acute Myeloid Leukemia
Principal Investigator: 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: 18-0709
Safety and Efficacy of Venetoclax and Azacitidine for Newly Diagnosed Non-Elderly Adult Patients (aged 18-59) with Acute Myeloid Leukemia
PI: Dan Pollyea
Eligibility: Ages 18-59; untreated AML; ECOG of ≤2
COMIRB: 20-1319
CC-486 and Venetoclax for Acute Myeloid Leukemia
PI: Dan Pollyea
Eligibility: Ages ≥ 18 years; non-APL AML and at least one line of therapy; ECOG of ≤ 2
COMIRB: 20-1388
A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Intravenously Administered IO-202 and IO-202 + Azacitidine ± Venetoclax in Acute Myeloid Leukemia (AML) Patients with Monocytic Differentiation and in Chronic Myelomonocytic Leukemia (CMML) Patients
PI: Dan Pollyea
Eligibility: Ages ≥ 18 years; Relapsed or refractory AML with myelomonocytic or monoblastic/monocytic differentiation and has failed treatment with available therapies known to be active for AML; Relapsed or refractory LILRB4high AML with myelomonocytic or monoblastic/monocytic differentiation and has failed treatment with available therapies known to be active for AML; Newly diagnosed high LILRB4 expression monocytic AML patients considered to be ineligible for standard induction therapy; 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: 21-3416
Tamibarotene in Combination with Venetoclax and Azacitidine in Previously Untreated Adult Patients Selected for RARA-positive AML Who Are Ineligible for Standard Induction Therapy
PI: Christine McMahon
Eligibility: Ages ≥ 18 years; untreated non-acute promyelocytic leukemia (APL) AML with a bone marrow or peripheral blood blast count ≥20%; must be willing to undergo a blood sample for RARA biomarker investigational assay testing with confirmed RARA-positive results prior to C1D8
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: 22-1050
A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients with Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation
PI: Christine McMahon
Eligibility: Ages ≥ 18 years; Active Acute Leukemia harboring MLL rearrangement or NPM1c mutation (Arm A, B); Active Acute Leukemia harboring MLL rearrangement, NUP98 rearrangement or NPM1c mutation (Arm C, D, E, F); R/R Acute Leukemia (Phase 1) R/R ALL/MPAL/AML with an MLLr translocation or AML with NPM1c (Phase 2), 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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