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NCT03530683TerminatedPhase 1

A Clinical Trial to Learn About the Study Medicine Called Maplirpacept (PF-07901801), Alone and When Used in Combination With Other Medicines to Treat Participants With Advanced Hematological Malignancies, Including Lymphoma, Leukemia and Multiple Myeloma

A Phase 1a/1b Dose-Escalation and Expansion Trial of TTI-622 in Patients With Advanced Hematologic Malignancies, Including Lymphoma, Leukemia, and Multiple Myeloma

Source: ClinicalTrials.gov · Last updated 3 Sept 2024

Reason given: A business decision was made by Pfizer to terminate the study. Termination was not due to any safety concerns, requests from regulatory authorities, changes to the benefit/risk profile or any new concerns regarding the investigational product.

Brief summary (registry, in English)

The purpose of this clinical trial is to learn how the experimental medicine maplirpacept (PF-07901801) affects people with various types of blood cancers: * relapsed or refractory (R/R) lymphoma * multiple myeloma * newly diagnosed acute myeloid leukemia (AML). This trial will be conducted in the outpatient setting in 2 parts, phase 1a and phase 1b. You may only participate in one part of the study. During phase 1a of this study, we will explore how much maplirpacept (PF-07901801), when used by itself, can be safely used. If you have lymphoma, the study medicine maplirpacept (PF-07901801) will be given by infusion through a vein once a week or once every 2 weeks or every 3 weeks as determined by your doctor. Following your first dose, you will be expected to come back twice more the first week. From week 2, you will have weekly visits for blood tests, questions about your medications, any side effects, or illnesses you may have experienced and your cancer response. After you have completed 21 days (for every week dosing) or 42 days (for every 2- or 3-weeks dosing), your doctor will discuss whether you should stop study treatment or continue. If you continue, you will be expected to come back weekly for blood tests, vital signs, a brief physical exam, asked about any side effects or illnesses you may have experienced and medications you may be taking. The dosing schedule you are assigned to will continue until your disease has worsened, significant side effects occur or other reasons that lead you and your doctor to decide treatment may be stopped. To be eligible for the first part of the study you must be 18 years or older, your disease has worsened after receiving other medicines approved for blood cancer, no other treatment options exist for you, a sample of your tissue for exploratory research which can be taken from tissue already obtained or if necessary, a new sample of your tissue will be taken so your disease may be seen and measured on routine tests/scans. If you have had radiation therapy or received any anticancer medication within 14 days before the planned start of study treatment your doctor will let you know if you are eligible to participate in the study. If you have had major surgery within 30 days before the planned start of study treatment you may not be eligible to participate. The phase 1a part of the study may last up to 51/2 years. How long you participate in this study depends on side effects you may have to the study drug. It also depends on how your cancer responds to the study drug. Therefore, you may remain in the study as long as you and your study doctor think you may benefit. However, you are free to stop taking part in this study at any time and for any reason. During phase 1b part of this study, we will explore how much maplirpacept (PF-07901801), when used with other anticancer medicine(s), can be safe and reduce cancer growth. In the phase 1b part of this study, you will receive maplirpacept (PF-07901801) and other anticancer medicine(s). Which medicine combination you will receive depends on the types of cancer under treatment. Your treatment experiences will be examined to determine if maplirpacept (PF-07901801) when given with other anticancer medicine(s), is safe and can reduce cancer growth. To be eligible for the second part of the study you may have newly diagnosed Acute Myelocytic Leukemia with or without a genetic mutation or you have Multiple Myeloma or Diffuse Large B Cell Lymphoma, and your disease has worsened. The Phase 1b part of this study may last as long as you and your study doctor think you may benefit which could be up to approximately 31/2 years. How long you participate in this study depends on side effects you may have to the study drug. It also depends on how your cancer responds to the study drug. Therefore, you may remain in the study as long as you and your study doctor think you may benefit. However, you are free to stop taking part in this study at any time and for any reason.

Status (registry)
Terminated
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
189 (actual)
First submitted
8 May 2018
Start date
14 May 2018
Primary completion date
18 Jul 2024
Lead sponsor
Pfizer
NCT number
NCT03530683

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of any investigational agent or any anticancer drug within 14 days before planned start of study treatment (within 4 weeks for antibody-based therapies and within 8 weeks for cell-based therapies).
  • Subjects who have undergone radiation therapy within 14 days of study treatment administration.
  • Hematopoietic stem cell transplant within 90 days before the planned start of study treatment or subjects with active graft-vs-host disease, with the exception of Grade 1 skin involvement.
  • Major surgery within 30 days before planned start of study treatment.

Other illness

  • Known, current central nervous system disease involvement.

Who the study is looking for

  • Available fresh or archived tumor tissue.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
  • Adequate coagulation function.
  • Adequate hepatic function.
  • Adequate hematologic status.
  • Adequate renal function.
  • Recovery from non-hematopoietic toxicities of previous anticancer drugs or radiotherapy or previous surgeries to ≤Grade 1 (or to baseline grade if condition was pre-existing).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (62)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University of Michigan HospitalsAnn ArborUnited StatesUnknown status
University of MichiganAnn ArborUnited StatesUnknown status
Blood and Marrow Transplant Group of GeorgiaAtlantaUnited StatesUnknown status
Northside HospitalAtlantaUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center at Basking RidgeBasking RidgeUnited StatesUnknown status
Roswell Park Cancer InstituteBuffaloUnited StatesUnknown status
Gabrail Cancer Center ResearchCantonUnited StatesUnknown status
Novant Health Cancer Institute Hematology - CharlotteCharlotteUnited StatesUnknown status
Novant Health Cancer Institute - Research OfficeCharlotteUnited StatesUnknown status
Novant Health Presbyterian Medical CenterCharlotteUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center at CommackCommackUnited StatesUnknown status
Colorado Blood Cancer InstituteDenverUnited StatesUnknown status
HealthONE Presbyterian/St. Luke's Medical CenterDenverUnited StatesUnknown status
Barbara Ann Karmanos Cancer InstituteDetroitUnited StatesUnknown status
Karmanos Cancer Institute Weisberg Cancer Treatment CenterFarmington HillsUnited StatesUnknown status
Summit Medical Group Cancer CenterFlorham ParkUnited StatesUnknown status
Prisma Health-Upstate Cancer InstituteGreenvilleUnited StatesUnknown status
Prisma Health, Institute for Translational Oncology Research, Clinical Research UnitGreenvilleUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center at WestchesterHarrisonUnited StatesUnknown status
The University of Texas MD Anderson Cancer CenterHoustonUnited StatesUnknown status
Oncology Consultants, P.A.HoustonUnited StatesUnknown status
Indiana Blood & Marrow TransplantationIndianapolisUnited StatesUnknown status
Indiana Blood and Marrow Transplantation-Administrative OfficesIndianapolisUnited StatesUnknown status
Indiana Blood and Marrow Transplantation-ClinicIndianapolisUnited StatesUnknown status
University of TN Medical CenterKnoxvilleUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center - Investigational Drug Service PharmacyLong Island CityUnited StatesUnknown status
Keck Hospital of USCLos AngelesUnited StatesUnknown status
LAC & USC Medical CenterLos AngelesUnited StatesUnknown status
USC / Norris Comprehensive Cancer CenterLos AngelesUnited StatesUnknown status
Norton Cancer Institute, St. Matthews Campus, Attn. Becky Champion, PharmDLouisvilleUnited StatesUnknown status
Norton Diagnostic Center-Dupont (PET Scans)LouisvilleUnited StatesUnknown status
Norton Cancer Institute, St. Matthews CampusLouisvilleUnited StatesUnknown status
Norton Women & Children's HospitalLouisvilleUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center at MonmouthMiddletownUnited StatesUnknown status
Memorial Sloan Kettering BergenMontvaleUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center at MontvaleMontvaleUnited StatesUnknown status
Christiana Care Hematology Oncology - Helen F Graham Cancer CenterNewarkUnited StatesUnknown status
Christiana Care Health Services - Christiana HospitalNewarkUnited StatesUnknown status
Medical Oncology Hematology Consultants, PA, Helen F. Graham Cancer CenterNewarkUnited StatesUnknown status
Christiana Care Health ServicesNewarkUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center-David H. Koch CenterNew YorkUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center (Outpatient Center)New YorkUnited StatesUnknown status
Memorial Sloan-Kettering Cancer CenterNew YorkUnited StatesUnknown status
Keck Hospital of USC PasadenaPasadenaUnited StatesUnknown status
Thomas Jefferson University Investigational Drug ServicesPhiladelphiaUnited StatesUnknown status
Sidney Kimmel Cancer Center, Research Support ServicesPhiladelphiaUnited StatesUnknown status
Thomas Jefferson University - Medical OncologyPhiladelphiaUnited StatesUnknown status
Thomas Jefferson UniversityPhiladelphiaUnited StatesUnknown status
Thomas Jefferson University, Investigational Drug ServicePhiladelphiaUnited StatesUnknown status
Thomas Jefferson University - Clinical Research InstitutePhiladelphiaUnited StatesUnknown status
Sidney Kimmel Cancer Center, Clinical Trials OrganizationPhiladelphiaUnited StatesUnknown status
West Penn HospitalPittsburghUnited StatesUnknown status
Swedish Cancer InstituteSeattleUnited StatesUnknown status
Swedish Medical CenterSeattleUnited StatesUnknown status
Tampa General HospitalTampaUnited StatesUnknown status
Tampa General Hospital-Cancer InstituteTampaUnited StatesUnknown status
Montefiore Medical CenterThe BronxUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center at NassauUniondaleUnited StatesUnknown status
Georgetown University Medical CenterWashington D.C.United StatesUnknown status
Novant Health Cancer Institute - Research OfficeWinston-SalemUnited StatesUnknown status
Novant Health Forsyth Medical CenterWinston-SalemUnited StatesUnknown status
Novant Health Cancer Institute Hematology- ForsythWinston-SalemUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.