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
Sites (62)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Hospitals | Ann Arbor | United States | Unknown status |
| University of Michigan | Ann Arbor | United States | Unknown status |
| Blood and Marrow Transplant Group of Georgia | Atlanta | United States | Unknown status |
| Northside Hospital | Atlanta | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center at Basking Ridge | Basking Ridge | United States | Unknown status |
| Roswell Park Cancer Institute | Buffalo | United States | Unknown status |
| Gabrail Cancer Center Research | Canton | United States | Unknown status |
| Novant Health Cancer Institute Hematology - Charlotte | Charlotte | United States | Unknown status |
| Novant Health Cancer Institute - Research Office | Charlotte | United States | Unknown status |
| Novant Health Presbyterian Medical Center | Charlotte | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center at Commack | Commack | United States | Unknown status |
| Colorado Blood Cancer Institute | Denver | United States | Unknown status |
| HealthONE Presbyterian/St. Luke's Medical Center | Denver | United States | Unknown status |
| Barbara Ann Karmanos Cancer Institute | Detroit | United States | Unknown status |
| Karmanos Cancer Institute Weisberg Cancer Treatment Center | Farmington Hills | United States | Unknown status |
| Summit Medical Group Cancer Center | Florham Park | United States | Unknown status |
| Prisma Health-Upstate Cancer Institute | Greenville | United States | Unknown status |
| Prisma Health, Institute for Translational Oncology Research, Clinical Research Unit | Greenville | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center at Westchester | Harrison | United States | Unknown status |
| The University of Texas MD Anderson Cancer Center | Houston | United States | Unknown status |
| Oncology Consultants, P.A. | Houston | United States | Unknown status |
| Indiana Blood & Marrow Transplantation | Indianapolis | United States | Unknown status |
| Indiana Blood and Marrow Transplantation-Administrative Offices | Indianapolis | United States | Unknown status |
| Indiana Blood and Marrow Transplantation-Clinic | Indianapolis | United States | Unknown status |
| University of TN Medical Center | Knoxville | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy | Long Island City | United States | Unknown status |
| Keck Hospital of USC | Los Angeles | United States | Unknown status |
| LAC & USC Medical Center | Los Angeles | United States | Unknown status |
| USC / Norris Comprehensive Cancer Center | Los Angeles | United States | Unknown status |
| Norton Cancer Institute, St. Matthews Campus, Attn. Becky Champion, PharmD | Louisville | United States | Unknown status |
| Norton Diagnostic Center-Dupont (PET Scans) | Louisville | United States | Unknown status |
| Norton Cancer Institute, St. Matthews Campus | Louisville | United States | Unknown status |
| Norton Women & Children's Hospital | Louisville | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center at Monmouth | Middletown | United States | Unknown status |
| Memorial Sloan Kettering Bergen | Montvale | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center at Montvale | Montvale | United States | Unknown status |
| Christiana Care Hematology Oncology - Helen F Graham Cancer Center | Newark | United States | Unknown status |
| Christiana Care Health Services - Christiana Hospital | Newark | United States | Unknown status |
| Medical Oncology Hematology Consultants, PA, Helen F. Graham Cancer Center | Newark | United States | Unknown status |
| Christiana Care Health Services | Newark | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center-David H. Koch Center | New York | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center (Outpatient Center) | New York | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center | New York | United States | Unknown status |
| Keck Hospital of USC Pasadena | Pasadena | United States | Unknown status |
| Thomas Jefferson University Investigational Drug Services | Philadelphia | United States | Unknown status |
| Sidney Kimmel Cancer Center, Research Support Services | Philadelphia | United States | Unknown status |
| Thomas Jefferson University - Medical Oncology | Philadelphia | United States | Unknown status |
| Thomas Jefferson University | Philadelphia | United States | Unknown status |
| Thomas Jefferson University, Investigational Drug Service | Philadelphia | United States | Unknown status |
| Thomas Jefferson University - Clinical Research Institute | Philadelphia | United States | Unknown status |
| Sidney Kimmel Cancer Center, Clinical Trials Organization | Philadelphia | United States | Unknown status |
| West Penn Hospital | Pittsburgh | United States | Unknown status |
| Swedish Cancer Institute | Seattle | United States | Unknown status |
| Swedish Medical Center | Seattle | United States | Unknown status |
| Tampa General Hospital | Tampa | United States | Unknown status |
| Tampa General Hospital-Cancer Institute | Tampa | United States | Unknown status |
| Montefiore Medical Center | The Bronx | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center at Nassau | Uniondale | United States | Unknown status |
| Georgetown University Medical Center | Washington D.C. | United States | Unknown status |
| Novant Health Cancer Institute - Research Office | Winston-Salem | United States | Unknown status |
| Novant Health Forsyth Medical Center | Winston-Salem | United States | Unknown status |
| Novant Health Cancer Institute Hematology- Forsyth | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.