Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN

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.
 
ClinicalTrials.gov Identifier: NCT03386513
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : July 12, 2021
Sponsor:
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 anti-leukemia activity of IMGN632 when administered as monotherapy to patients with CD123+ disease.

The study is enrolling a pivotal cohort of frontline BPDCN patients and a cohort of relapsed/refractory BPDCN patients.


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

Detailed Description:
The study completed a dose escalation phase, and is now enrolling in a dose expansion phase to further characterize the safety profile and to assess the efficacy of IMGN632 in patients with BPDCN. IMGN632 is administered by IV on Day 1 of each cycle, with cycles repeating every 21 days.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 252 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 : June 2022
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
Experimental: Escalation and Expansion

Escalation: IMGN632 was administered by IV on 2 different schedules for patients with relapsed/refractory AML or BPDCN.

Expansion: the study is currently enrolling in 2 BPDCN expansion cohorts at the RP2D:

  • Cohort 1: Relapsed or refractory BPDCN patients who have received 1-3 prior systemic therapies (incl. tagraxofusp-erzs and/or any other systemic therapy deemed appropriate for the treatment of BPDCN)
  • Cohort 6: Pivotal cohort for frontline BPDCN patients who have not received prior systemic therapy. Patients may have received local therapy (radiotherapy, surgical excision, photodynamic therapy). Eligible patients must have a recurrence or progression in the field of local therapy OR disease outside the field of local therapy.

Other expansion cohorts (not currently enrolling):

• Cohort 2: Relapsed AML; Cohort 3: Relapsed or refractory ALL; Cohort 4: Other relapsed or refractory hematologic malignancies; Cohort 5: Relapsed or refractory AML at alternate dose or schedule

Drug: IMGN632
CD123-targeted ADC




Primary Outcome Measures :
  1. To assess the rate of composite CR in BPDCN patients [ Time Frame: 21-day cycle ]
    CR+clinical CR [CRc]


Secondary Outcome Measures :
  1. To assess the duration of CR (DOCR) for patients with CR or CRc [ Time Frame: Up to 24 months ]
  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: Up to 24 months ]
  3. To assess the rate of CR+CRc+CRh [ Time Frame: Up to 24 months ]
  4. To assess the duration of CR+CRc+CRh [ Time Frame: Up to 24 months ]
  5. To assess ORR: CR+CRc+CRh+CRi+PR [ Time Frame: Up to 24 months ]
  6. To assess the duration of overall response [ Time Frame: Up to 24 months ]
  7. To assess OS [ Time Frame: Up to 24 months ]
  8. To assess the percent of BPDCN patients able to bridge to stem cell transplant in the frontline and relapsed/refractory populations separately [ Time Frame: Up to 24 months ]
  9. To characterize the PK of IMGN632, total antibody, and FGN849 (the active catabolite) [ Time Frame: Up to 24 months ]
  10. To evaluate the potential immunogenicity of IMGN632 [ Time Frame: Up to 24 months ]
    ADA

  11. To assess transfusion independence [ Time Frame: Up to 24 months ]
    Conversion rate to independence of red blood cell (RBC) and platelet transfusion relative to baseline



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.


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

Inclusion Criteria:

  1. Disease Characteristics:

    a. 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. Expansion inclusion:

    • Cohort 1 - Patients with relapsed or refractory BPDCN with 1-3 prior lines of therapy
    • 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, BP- CML). Other CD123+ malignancies may be considered upon discussion with the Sponsor.
    • Cohort 5 - Patients will have relapsed or refractory (to non-intense therapies) AML.
    • Cohort 6 - Patients with frontline BPDCN who have not received prior systemic therapy.

Note: Patients in Cohort 6 may have received local therapy (radiotherapy, surgical excision, photodynamic therapy). Eligible patients must have a recurrence or progression in the field of local therapy OR disease outside the field of local therapy.

Exclusion Criteria:

  1. Patients who, in the judgment of their treating physician, have appropriate standard of care therapies will be excluded from Cohorts 1 through 5.
  2. Frontline BPDCN patients with central nervous system (CNS) disease will be excluded. A lumbar puncture must be performed during the 28-day screening period, prior to drug administration. Relapsed or refractory BPDCN patients with a known history of CNS disease must have been treated locally, have at least 1 lumbar puncture with no evidence of CNS disease, and must be clinically stable prior to first dose. Concurrent therapy for CNS prophylaxis or continuation of therapy for controlled CNS disease is permitted with the approval of the Sponsor.
  3. Patients with a history of veno-occlusive disease of the liver.
  4. Patients with a history of Grade 4 capillary leak syndrome, or non-cardiac Grade 4 edema are ineligible, eg, related to tagraxofusp-erzs or other etiology.
  5. Interval from prior cancer therapy: 1. For frontline BPDCN patients with prior local therapy (eg, radiotherapy), patients must not have received treatment within 14 days prior to drug administration on this study. 2. Relapsed or refractory BPDCN patients must not have received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational agents within 14 days prior to drug administration on this study. Patients must have recovered to baseline from all acute toxicity from this prior therapy.

Note: the exception that patients who have received a checkpoint inhibitor must not have received that therapy within 28 days 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 ClinicalTrials.gov identifier (NCT number): NCT03386513


Contacts
Layout table for location contacts
Contact: ImmunoGen Clinical Trials 781-895-0600 medicalaffairs@immunogen.com

Locations
Layout table for location information
United States, Arizona
Banner Health MD Anderson Cancer Center Not yet recruiting
Gilbert, Arizona, United States, 85234
Contact: Jana Bergelin, MS    480-440-7458    BMDACCResearch@bannerhealth.com   
Principal Investigator: Matthew Ulrickson, MD         
United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Ahmed Aribi, MD    626-218-1133    aaribi@coh.org   
Contact    877-467-3411      
Principal Investigator: Ahmed Aribi, MD         
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Christine Ternival    813-745-2629    christine.ternival@moffitt.org   
Principal Investigator: Kendra Sweet, MD         
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Daniel DeAngelo, MD    617-632-2645    Daniel_DeAngelo@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 Halliwell    716-845-4971    Stephanie.Halliwell@RoswellPark.org   
Contact: Eunice Wang, MD    716-845-3544    Eunice.Wang@RoswellPark.org   
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    rachel.stowe@duke.edu   
Contact: Susan Jones, BSN, RN    919-681-4769    susan.k.jones@duke.edu   
Principal Investigator: Harry Erba, MD, PhD         
United States, Texas
Baylor Scott & White University Medical Center Recruiting
Dallas, Texas, United States, 75246
Contact: Moshe Levy, MD    214-818-8472      
Principal Investigator: Moshe Y Levy, MD         
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030-7095
Contact    713-794-4392    ndaver@mdanderson.org   
Principal Investigator: Naval Daver, MD         
United States, Washington
Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Rebecca White    206-667-5226    rlwhite@fredhutch.org   
Contact: Kaysey Orlowski    206-667-1997    korlowsk@fredhutch.org   
Principal Investigator: Roland Walter, MD         
France
Recherche Clinique-Hématologie Recruiting
Amiens, France
Contact: Delphine Lebon, MD    +33 3 22 45 59 14    lebon.delphine@chu-amiens.fr   
CHU de Besancon, Hopital Jean Minjoz Recruiting
Besançon, France, 25030
Contact: Eric Deconinck, MD    +33381668232    eric.deconinck@univ-fcomte.fr   
Principal Investigator: Eric Deconinck, MD         
Hôpital St Antoine Not yet recruiting
Paris, France
Contact: Olliver Legrand, MD    +33 1 49 28 34 41    ollivier.legrand@sat.aphp.fr   
Principal Investigator: Olliver Legrand, MD         
Italy
Instituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Recruiting
Meldola, Italy, 47014
Contact: Federica Frabetti       federica.frabetti@irst.emr.it   
Contact: Giovanni Martinelli, MD    +39 0543 739480    Giovanni.martinelli@irst.emr.it   
Principal Investigator: Giovanni Martinelli, MD         
Instituto Europeo di Oncologia Recruiting
Milano, Italy, 20141
Contact: Chiara Busacca    +39 02 94372 161    Chiara.Busacca@ieo.it   
Contact: Maria Chiara Massaro    +39 02 57489 403    maria.massaro@ieo.it   
Principal Investigator: Corrado Tarella, MD         
Spain
Hospital Universitari I Politècnic La Fe Recruiting
Valencia, Spain, 46026
Contact: Pau Montsinos, MD    +34 96 1244925    montesinos_pau@gva.es   
Contact: David Bossis    +34 961 244 864    pellicer_dav@gva.es   
Principal Investigator: Pau Montesinos, MD         
Sponsors and Collaborators
ImmunoGen, Inc.
Investigators
Layout table for investigator information
Study Director: Patrick Zweidler-McKay, MD ImmunoGen, Inc.
Layout table for additonal information
Responsible Party: ImmunoGen, Inc.
ClinicalTrials.gov Identifier: NCT03386513    
Other Study ID Numbers: IMGN632-0801
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: July 12, 2021
Last Verified: July 2021

Layout table for additional information
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
CD123
MDS
Relapsed, Refractory
Acute Lymphocytic Leukaemia
Blastic Plasmacytoid Dendritic Cell Neoplasm
Acute Myeloid Leukemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Neoplasms
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
Bone Marrow Diseases
Hematologic Diseases