Clinical Trials Using Gemtuzumab Ozogamicin

Clinical trials are research studies that involve people. The clinical trials on this list are studying Gemtuzumab Ozogamicin. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-15 of 15
  • CPX-351 and Gemtuzumab Ozogamicin in Treating Patients with Relapsed Acute Myeloid Leukemia

    This phase Ib trial studies the best dose of gemtuzumab ozogamicin when given together with CPX-351 in treating patients with acute myeloid leukemia that has come back after it was previously in remission. CPX-351 is a type of chemotherapy. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to chemotherapy called calicheamicin. Gemtuzumab attaches to CD33 positive cancer cells in a targeted way and delivers ozogamicin to kill them. Giving CPX-351 and gemtuzumab ozogamicin may work better in treating patients with acute myeloid leukemia, compared to giving only one of these therapies alone.
    Location: 5 locations

  • Tretinoin and Arsenic Trioxide with or without Gemtuzumab Ozogamicin in Treating Patients with Previously Untreated Acute Promyelocytic Leukemia

    This phase II trial studies how well tretinoin and arsenic trioxide with or without gemtuzumab ozogamicin works in treating patients with previously untreated acute promyelocytic leukemia. Drugs used in chemotherapy, such as tretinoin and arsenic trioxide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to a chemotherapy drug called ozogamicin. Gemtuzumab attaches to CD33 positive cancer cells in a targeted way and delivers ozogamicin to kill them. Giving tretinoin and arsenic trioxide together with gemtuzumab ozogamicin may kill more cancer cells.
    Location: 5 locations

  • Gemtuzumab Ozogamicin and Midostaurin in Combination with Standard Chemotherapy in Treating Patients with CD33 Positive, FLT3-Mutated Newly Diagnosed Acute Myeloid Leukemia

    This phase I trial studies the side effects and best dose of gemtuzumab ozogamicin when given together with midostaurin, and to see how well they work with standard chemotherapy in treating patients with newly diagnosed acute myeloid leukemia that has an FLT3 genetic mutation and is positive for a protein called CD33. Gemtuzumab ozogamicin is a monoclonal antibody called gemtuzumab linked to a toxic agent called ozogamicin. Gemtuzumab attaches to CD33 positive cancer cells in a targeted way and delivers ozogamicin to kill them. Midostaurin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving gemtuzumab ozogamicin and midostaurin together with standard chemotherapy may work better in treating patients with acute myeloid leukemia compared to the usual approach.
    Location: 2 locations

  • Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113

    This is a Phase Ib Study to determine the Maximum Tolerated Dose (MTD) of Venetoclax in combination with Gemtuzumab Ozogamicin(GO) in subjects with relapsed / refractory acute myeloid leukemia. Using a standard 3+3 design, subjects will receive once cycle of combination therapy. After one cycle of combination therapy, subjects showing response will continue on to one cycle of consolidation therapy with GO\Veneoclax. Subjects who respond to combination therapy will continue on maintenance Venetoclax until progression or unacceptable toxicity. Dose-limiting toxicity, defined as an adverse event related (possible, probably, or definite) to Venetoclax and / or Gemtuzumab fulfilling one of the following criteria: - Hematologic toxicity: treatment-related grade 4 or worse bone marrow hypocellularity present at the end of cycle one (day 28); specifically grade 4 cytopenias (anemia, neutropenia and / or thrombocytopenia) with the bone marrow documented to be free of leukemic infiltration. Note: patients who enter the study with grade 3 or worse cytopenias will not be evaluable for hematologic dose-limiting toxicities. - Non-hematologic toxicity: any grade 3 or worse treatment-related toxicity (excluding grade 4 infections during cycle one). The study will also evaluate the Overall Response Rate, Anti-leukemic activity, Relapse-free Survival (RFS), event-free survival (EFS) , and overall survival (OS). The study will evaluate quality of life using the European Organization for the Research and Treatment of Cancer 30 item questionnaire (EORTC QLQ-C30).
    Location: Indiana University / Melvin and Bren Simon Cancer Center, Indianapolis, Indiana

  • Combination Chemotherapy with Gemtuzumab Ozogamicin for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

    This phase II trial identifies the side effects and the activity of combination chemotherapy and gemtuzumab ozogamicin for the treatment of acute myeloid leukemia that has come back (relapsed) or that does not respond to treatment (refractory). Chemotherapy drugs, such as cladribine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Granulocyte colony stimulating factor may improve white blood cells after chemotherapy for many cancers including acute myeloid leukemia. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to a toxic agent called ozogamicin. Gemtuzumab attaches to CD33 positive cancer cells in a targeted way and delivers ozogamicin to kill them. Other objectives of this trial are to assess how strong the responses are, look at the average length of time patients stay in remission and how long they live, and to see what proportion of patients move onto a stem-cell / bone marrow transplant safely. Also, this trial will look to see whether certain characteristics of leukemia cells are linked to response and survival. Giving combination chemotherapy and gemtuzumab ozogamicin may work better in treating patients with acute myeloid leukemia compared to chemotherapy alone.
    Location: University of Maryland / Greenebaum Cancer Center, Baltimore, Maryland

  • Mitoxantrone, Etoposide, and Gemtuzumab Ozogamicin in Treating Patients with Refractory Acute Myeloid Leukemia

    This phase II trial studies the side effects of mitoxantrone, etoposide, and gemtuzumab ozogamicin and to see how well they work in treating patients acute myeloid leukemia that does not respond to initial standard induction therapy. Drugs used in chemotherapy, such as mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Etoposide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Gemtuzumab ozogamicin is a monoclonal antibody, gemtuzumab, linked to a toxic agent called ozogamicin. Gemtuzumab attaches to CD33 positive cancer cells in a targeted way and delivers ozogamicin to kill them. This study is being done to see if the combination of mitoxantone, etoposide, and gemtuzumab ozogamicin improves the response rate in patients with acute myeloid leukemia that did not respond after a course of induction chemotherapy.
    Location: University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania

  • Fractionated Gemtuzumab Ozogamicin in Treating Measurable Residual Disease in Participants with Acute Myeloid Leukemia

    This phase II trial studies the how well fractionated gemtuzumab ozogamicin works in treating measurable residual disease in participants with acute myeloid leukemia. Immunotherapy with monoclonal antibodies, such as gemtuzumab ozogamicin, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington

  • Liposome-encapsulated Daunorubicin-Cytarabine and Gemtuzumab Ozogamicin in Treating Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome

    This phase II trial studies the side effects and how well liposome-encapsulated daunorubicin-cytarabine and gemtuzumab ozogamicin work in treating patients with acute myeloid leukemia that has come back (relapsed) or that does not respond to treatment (refractory) or high risk myelodysplastic syndrome. Drugs used in chemotherapy, such as liposome-encapsulated daunorubicin-cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to a toxic agent called calicheamicin. Gemtuzumab ozogamicin attached to CD33 positive cancer cells in a targeted way and delivers calicheamicin to kill them. Giving liposome-encapsulated daunorubicin-cytarabine and gemtuzumab ozogamicin together may be an effective treatment for relapsed or refractory acute myeloid leukemia or high risk myelodysplastic syndrome.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Gemtuzumab Ozogamicin with G-CSF, Cladribine, Cytarabine and Mitoxantrone in Treating Participants with Previously Untreated Acute Myeloid Leukemia or High-Grade Myeloid Neoplasm

    This phase I / II trial studies the side effects and best dosing frequency of gemtuzumab ozogamicin when given in combination with granulocyte colony stimulating factor (G-CSF), cladribine, cytarabine and mitoxantrone (GCLAM) and to see how well they work in treating participants with acute myeloid leukemia or high-grade myeloid tumors (neoplasms) that have not been previously treated. Antibody-drug conjugates, such as gemtuzumab ozogamicin, act by directly delivering toxic chemotherapy to cancer cells. Granulocyte colony stimulating factor is a growth factor used to stimulate leukemia cells and render them more sensitive to chemotherapy drugs. Drugs used in chemotherapy, such as cladribine, cytarabine and mitoxantrone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving gemtuzumab ozogamicin in combination with G-CSF, cladribine, cytarabine and mitoxantrone hydrochloride may work better in treating participants with acute myeloid leukemia or high-grade myeloid neoplasm.
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington

  • OX40, Venetoclax, Avelumab, Glasdegib, Gemtuzumab Ozogamicin, and Azacitidine in Treating Patients with Relapsed or Refractory Acute Myeloid Leukemia

    This phase Ib / II trial studies the side effects and best dose of anti-OX40 antibody PF-04518600 (OX40) and how well it works alone or in combination with venetoclax, avelumab, glasdegib, gemtuzumab ozogamicin, and azacitidine in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as OX40 and avelumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to a toxic agent called calicheamicin. Gemtuzumab attaches to CD33 positive cancer cells in a targeted way and delivers calicheamicin to kill them. Glasdegib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as venetoclax and azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving OX40, venetoclax, avelumab, glasdegib, gemtuzumab ozogamicin, and azacitidine may work better in treating patients with acute myeloid leukemia.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients with Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

    This phase II trial studies the side effects and how well fludarabine phosphate, cytarabine, filgrastim-sndz, gemtuzumab ozogamicin, and idarubicin hydrochloride work in treating patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. Drugs used in chemotherapy, such as fludarabine phosphate, cytarabine, and idarubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Immunotherapy with monoclonal antibodies, such as gemtuzumab ozogamicin, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Colony-stimulating factors, such as filgrastim-sndz, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving fludarabine phosphate, cytarabine, filgrastim-sndz, gemtuzumab ozogamicin, and idarubicin hydrochloride may kill more cancer cells.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Evaluating QTc, PK, Safety of Gemtuzumab Ozogamicin (GO) in Patients With CD33+ R / R AML

    This is a single‑arm, open‑label, Phase 4 study evaluating the effect of GO on the QTc, pharmacokinetics, safety, and immunogenicity of GO as a single‑agent monotherapy in adult and pediatric patients with relapsed or refractory CD33‑positive AML.
    Location: Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia

  • Modified Chemotherapy Regimen and Gemtuzumab Ozogamicin for the Treatment of Newly Diagnosed Acute Myeloid Leukemia in Pediatric Patients

    This phase I trial studies how well a modified chemotherapy regimen with gemtuzumab ozogamicin works for the treatment of newly diagnosed acute myeloid leukemia in pediatric patients. The current standard of care to treat most pediatric patients with acute myeloid leukemia is 5 cycles of chemotherapy. Adjusting treatment with a 4-cycle treatment regimen may provide the same treatment results and decrease the amount of side effects experienced during treatment. Gemtuzumab ozogamicin is a monoclonal antibody, gemtuzumab, linked to a toxic agent called calicheamicin. Gemtuzumab attaches to CD33 positive cancer cells in a targeted way and delivers calicheamicin to kill them. Giving gemtuzumab ozogamicin with the 4-cycle treatment regimen may also reduce the chances of acute myeloid leukemia coming back after initial treatment.
    Location: Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia

  • Talazoparib and Gemtuzumab Ozogamicin for the Treatment of CD33 Positive Relapsed or Refractory Acute Myeloid Leukemia

    This phase I / Ib trial studies the side effects and best dose of talazoparib given together with gemtuzumab ozogamicin and to see how well they work in treating patients with CD33 positive acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). Talazoparib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Gemtuzumab ozogamicin is a protein (antibody) combined with a chemotherapy drug which specifically targets acute myeloid leukemia cells expressing a marker (CD33). Adding talazoparib to the gemtuzumab ozogamicin therapy may lead to an increased effectiveness in treatment.
    Location: Roswell Park Cancer Institute, Buffalo, New York

  • Dexrazoxane Hydrochloride in Preventing Heart-Related Side Effects of Chemotherapy in Patients with Blood Cancers

    This phase II trial studies how well dexrazoxane hydrochloride works in preventing heart-related side effects of chemotherapy in patients with blood cancers, such as acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia, and myeloproliferative neoplasms. Chemoprotective drugs, such as dexrazoxane hydrochloride, may protect the heart from the side effects of drugs used in chemotherapy, such as cladribine, idarubicin, cytarabine, and gemtuzumab ozogamicin, in patients with blood cancers.
    Location: M D Anderson Cancer Center, Houston, Texas