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The clinical research mission of the Adult Leukemia Program is to develop and bring new and better therapies to patients. At any given time, the program offers patients a wide array of opportunities to participate in clinical research studies relating to all stages and types of leukemia and related disorders. Patients have access to trials that originate within Dana-Farber Brigham Cancer Center and other Harvard-affiliated institutions, those sponsored by private industry, as well as those that are part of a collaborative effort, such as the Cancer and Leukemia Group B, of which the program is a member.
The clinical research mission of the Adult Leukemia Program is to develop and bring new and better therapies to patients. At any given time, the program offers patients a wide array of opportunities to participate in clinical research studies relating to all stages and types of leukemia and related disorders.
Patients have access to trials that originate within Dana-Farber Brigham Cancer Center and other Harvard-affiliated institutions, those sponsored by private industry, as well as those that are part of a collaborative effort, such as the Cancer and Leukemia Group B, of which the program is a member.
Physician-researchers within the program are currently involved in a number of exciting avenues of investigation, which include targeted therapies aimed at making cancer treatment more specific and less toxic. These include:
Other innovative offerings include treating adults with acute lymphoblastic leukemia by applying the principles used in successful pediatric treatments of this condition and clinical trials and treatments specialized for older adults.
Newly-diagnosed AML
18-351: A phase 1b study of venetoclax in combination with intensive induction and consolidation chemotherapy in treatment-naïve patients with acute myelogenous leukemia Principal Investigator: Richard Stone, MD
17-623: A phase 3 randomized study of crenolanib versus midostaurin administered following induction chemotherapy and consolidation therapy in newly-diagnosed patients with FLT3 mutated acute myeloid leukemia Principal Investigator: Richard Stone, MD
Relapsed/refractory AML
19-606: A phase 1b/2 study of IMGN632 as monotherapy or combination with venetoclax and/or azacitidine for patients with CD123-positive acute myeloid leukemia Principal Investigator: Daniel DeAngelo, MD, PhD
19-467: 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 Principal Investigator: Richard Stone, MD
18-013: A phase 1/2, multicenter, open-label study of IMGN632 monotherapy administered intravenously in patients with CD123-positive acute myeloid leukemia and other CD123-positive hematologic malignanciesPrincipal Investigator: Daniel DeAngelo, MD, PhD
Newly-diagnosed ALL
21-272: A multicenter, open-label, single-arm phase 2/3 trial evaluating the safety and pharmacokinetics of calaspargase pegol for treatment of adults aged 22 to >65 years with newly diagnosed Philadelphia-negative ALL Principal Investigator: Daniel DeAngelo, MD, PhD
16-648: A phase 1b/2 study of the combination of venetoclax with chemotherapy as frontline therapy in older patients with acute lymphoblastic leukemia Principal Investigator: Marlise Luskin, MD, MSCE
Relapsed/refractory ALL
20-562: A phase I, 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) Principal Investigator: Daniel DeAngelo, MD, PhD
20-272: An open-label, multicenter phase 1b/2 study evaluating the safety and efficacy of AUTO1, a CAR T-cell treatment targeting CD19, in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia Principal Investigator: Daniel DeAngelo, MD, PhD
18-608: A phase 1/2a, open-label, dose-escalation, dose-expansion, parallel assignment study to evaluate the safety and clinical activity of PBCAR0191 in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) Principal Investigator: Caron Jacobson, MD, MMSc
21-196: A phase 1 study of venetoclax in combination with inotuzumab ozogamicin for B-cell acute lymphoblastic leukemia (B-ALL)Principal Investigator: Marlise Luskin, MD, MSCE
Marlise Luskin, MD, MSCE, a specialist in the Adult Leukemia Program at Dana-Farber Cancer Institute, explains an innovative trial that combines venetoclax with chemotherapy for older patients with ALL. Learn more about this study.
Newly-diagnosed MDS
20-363: ENHANCE: A randomized, double-blind, multicenter study comparing magrolimab in combination with azacitidine versus azacitidine plus placebo in treatment-naïve patients with higher risk myelodysplastic syndrome Principal Investigator: Daniel DeAngelo, MD, PhD
High-Risk Myeloid Malignancies
22-263: A phase 1 study of triplet therapy with navitoclax, venetoclax, and decitabine for high-risk myeloid malignancies Principal Investigator: Jacqueline Garcia, MD
Myelofibrosis
21-714: A randomized, open-label, phase 3 study evaluating efficacy and safety of navitoclax in combination with ruxolitinib versus best available therapy in patients with relapsed/refractory myelofibrosisPrincipal Investigator: Jacqueline Garcia, MD
Advanced Systemic Mastocytosis
21-358: A phase 2 open-label, multicenter clinical study of the safety, efficacy, pharmacokinetic, and pharmacodynamic profiles of CGT9486 as a single agent in patients with advanced systemic mastocytosisPrincipal Investigator: Daniel DeAngelo, MD, PhD
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