Adult Leukemia Program

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:

• immunotherapy for acute leukemia and myelodysplasia involving agents such as interleukin-2 and autologous vaccines
• integrating antibody-based therapy against leukemia cells with standard chemotherapy
• promoting the differentiation or normal growth of bone marrow cells in patients with myelodysplasia
• working with molecules that interrupt the normal cascade of biochemical signals within the cell that promote the growth of leukemia

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.

Featured Clinical Trials

Acute Myeloid Leukemia

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 malignancies
Principal Investigator: Daniel DeAngelo, MD, PhD

Acute Lymphoblastic Leukemia

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

Other Myeloid Malignancies

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 myelofibrosis
Principal 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 mastocytosis
Principal Investigator: Daniel DeAngelo, MD, PhD