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Study of IMGN632 in Patients With Relapse/Refractory AML, BPDCN, ALL, Other CD123+ Hem Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03386513
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : December 9, 2019
Jazz Pharmaceuticals
Information provided by (Responsible Party):
ImmunoGen, Inc.

Brief Summary:

This is an open-label, multi-center, Phase 1/2 study to determine the MTD and assess the safety, tolerability, PK, immunogenicity, and preliminary anti-leukemia activity of IMGN632 when administered as monotherapy to patients with CD123+ disease.

The study is currently enrolling eligible AML, BPDCN and ALL patients.

Condition or disease Intervention/treatment Phase
Acute Lymphocytic Leukaemia Blastic Plasmacytoid Dendritic Cell Neoplasm Myeloproliferative Neoplasm Acute Myeloid Leukemia Drug: IMGN632 Phase 1 Phase 2

Detailed Description:
The study comprises a dose escalation phase followed by a dose expansion phase to further characterize the safety profile and confirm the MTD. IMGN632 will be administered IV on Day 1 of each cycle, with cycles repeating every 21 days. Treatment will continue for up to 2 cycles (6 weeks) in the absence of disease progression (PD), treatment intolerance, or withdrawal of consent.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Multi-center, Open-label Study of IMGN632 Monotherapy Administered Intravenously in Patients With CD123-positive Acute Myeloid Leukemia and Other CD123-positive Hematologic Malignancies
Actual Study Start Date : January 2, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : February 2021

Arm Intervention/treatment
Experimental: Escalation and Expansion

Escalation: IMGN632 will be administered by IV on two different schedules for patients with relapsed/refractory AML or BPDCN:

Schedule A: Day 1 of each cycle, with cycles repeating every 21 days

Schedule B: Days 1, 4 and 8 of each cycle, with cycles repeating every 21 days

Expansion: IMGN632 will be administered based on the recommended phase 2 dose (RP2D) and schedule as determined in the Escalation Phase, across five expansion cohorts, for patients with 1) relapsed, refractory OR selected untreated BPDCN; 2) relapsed AML; 3) relapsed or refractory ALL; 4) other relapsed or refractory CD123+ hematologic malignancies; 5) other relapsed or refractory AML.

Drug: IMGN632
CD123-targeted ADC

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) and recommended Ph2 dose (RP2D) [ Time Frame: 28 Days ]
    To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of IMGN632 when administered as a single agent

Secondary Outcome Measures :
  1. Treatment emergent adverse events [ Time Frame: Up to 12 months ]
  2. Objective Response Rate (ORR) (complete response [CR= CR+CRp+CRi]+partial remission [PR]) [ Time Frame: Up to 12 months ]
  3. PK parameters: maximum plasma concentration (Cmax) of IMGN632 [ Time Frame: Up to 12 months ]
  4. PK parameters: area under the time-concentration curve (AUC) of IMGN632 [ Time Frame: Up to 12 months ]
  5. PK parameters: terminal half-life (t½) of IMGN632 [ Time Frame: Up to 12 months ]
  6. Immunogenicity: Presence of Antibody-Drug Antibody (ADA) [ Time Frame: Up to 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Disease Characteristics:

    1. Confirmation of CD123 positivity by flow cytometry or IHC. Patients who received prior CD123-targeting agents will be allowed as long as the blasts still have detectable CD123 expression.
    2. Dose Escalation - Relapsed or refractory AML (excluding acute promyelocytic leukemia) or BPDCN, based on World Health Organization Classification
    3. Dose Expansion

      • Cohort #1 - Patients with relapsed or refractory BPDCN OR patients with untreated BPDCN who are inappropriate for available therapies. BPDCN patients considered inappropriate for available therapies must be either ≥ 75 years of age OR 18 to 74 years of age if the patient has at least one comorbidity that the physician judges to be incompatible with intense and available therapies, eg, pulmonary, cardiac, hepatic, vascular comorbidities or is ineligible for available therapies eg, hypoalbuminemia (serum albumin < 3.2 mg/dL) as an exclusion for tagraxofusp (ELZONRIS).
      • Cohort #2 - Patients will have relapsed AML.
      • Cohort #3 - Patients will have relapsed or refractory ALL (including any subtypes: B-cell, T-cell, Ph+ and Ph-)
      • Cohort #4 - Patients will have relapsed or refractory other hematologic malignancies not included in the cohorts above (eg, high-risk/very high-risk MDS, MPN, CMML, CML blast crisis). Other CD123+ malignancies may be considered upon discussion with the Sponsor.
      • Cohort #5 - Patients will have relapsed or refractory (to non-intense therapies) AML.
  2. Prior therapies:

    1. Patients in Dose Escalation and Dose Expansion Cohort #1, #3, and #4 may have received up to four prior lines of therapy.
    2. Patients in Dose Expansion Cohort #2 with AML may have received up to two prior lines of therapy.
    3. Patients in Dose Expansion Cohort #5 with AML may have received up to three prior lines of therapy.

Exclusion Criteria:

  1. Patients who, in the judgment of their treating physician, have appropriate standard of care therapies will be excluded
  2. Patients with active central nervous system (CNS) disease will be excluded.
  3. Patients with a history of venous occlusive disease of the liver
  4. Patients with a history of Grade 4 capillary leak syndrome, or non-cardiac Grade edema are ineligible, eg, related to SL-401 or other etiology
  5. Myocardial infarction within six months prior to enrollment or has New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities prior to study entry
  6. Patients who have received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational agents within 14 days or five half-lives, whichever is greater (with exception of hydroxyurea), prior to drug administration on this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03386513

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Contact: ImmunoGen Clinical Trials 781-895-0115

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United States, Alabama
University of Alabama Birmingham Completed
Birmingham, Alabama, United States, 35294
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Justo Gonzalez   
Contact: Sabrina Hasan   
Principal Investigator: Kendra Sweet, MD         
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Ryan Osborn       RyanD_Osborn@DFCI.HARVARD.EDU   
Principal Investigator: Daniel Deangelo, MD         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Stephanie MacDavid   
Contact: Angela Kader    716-845-4485   
Principal Investigator: Eunice Wang, MD         
United States, North Carolina
Duke Cancer Institute Recruiting
Durham, North Carolina, United States, 27710
Contact: Rachel Stowe, BSN, RN    919-681-4769   
Contact: Susan Jones, BSN, RN    919-681-4769   
Principal Investigator: Harry Erba, MD, PhD         
United States, Texas
Baylor Scott & White University Medical Center Recruiting
Dallas, Texas, United States, 75246
Contact: Lisa Jones    214-820-1970   
Principal Investigator: Moshe Y Levy, MD         
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030-7095
Contact: Joie Alvarez    713-792-7321   
Principal Investigator: Hagop Kantarjian, MD         
United States, Washington
Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Roland Walter, MD    206-667-5000   
Principal Investigator: Roland Walter, MD         
CHU de Besancon, Hopital Jean Minjoz Recruiting
Besançon, France, 25030
Contact: Eric Deconinck, MD    +33 (0)3 81 66 87 97   
Principal Investigator: Eric Deconinck, MD         
Instituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Recruiting
Meldola, Italy, 47014
Contact: Federica Frabetti    +39 0543 739290   
Contact: Giovanni Martinelli, MD    +39 0543 739480   
Principal Investigator: Giovanni Martinelli, MD         
Instituto Europeo di Oncologia Recruiting
Milano, Italy, 20141
Contact: Chiara Busacca    +39 02 57489 403   
Contact: Maria Chiara Massaro    +39 02 57489 403   
Principal Investigator: Corrado Tarella, MD         
Hospital Universitari I Politècnic La Fe Recruiting
Valencia, Spain, 46026
Contact: Pau Montsinos, MD    +34 961 245 876   
Contact: David Bossis    +34 961 244 864   
Principal Investigator: Pau Montesinos, MD         
Sponsors and Collaborators
ImmunoGen, Inc.
Jazz Pharmaceuticals
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Study Director: Patrick Zweidler-McKay, MD ImmunoGen, Inc.
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Responsible Party: ImmunoGen, Inc. Identifier: NCT03386513    
Other Study ID Numbers: IMGN632-0801
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ImmunoGen, Inc.:
Antibody Drug Conjugate
Other Hematologic Malignancies
Myeloproliferative Neoplasms
Relapsed, Refractory
Acute Lymphocytic Leukaemia
Blastic Plasmacytoid Dendritic Cell Neoplasm
Acute Myeloid Leukemia
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Myeloproliferative Disorders
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases
Bone Marrow Diseases