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DRUG CLASS:

DNA replication inhibitor

7d
Bendamustine With or Without Cyclophosphamide in Preventing GVHD in Patients Undergoing Stem Cell Transplant (clinicaltrials.gov)
P1/2, N=25, Recruiting, M.D. Anderson Cancer Center | N=40 --> 25 | Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Jul 2024 --> Jul 2025
Enrollment change • Trial completion date • Trial primary completion date • Post-transplantation
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Rituxan (rituximab) • cyclophosphamide • bendamustine • melphalan • fludarabine IV • Neupogen (filgrastim)
8d
ASCT2-Targeting Antibody-Drug Conjugate MEDI7247 in Adult Patients with Relapsed/Refractory Hematological Malignancies: A First-in-Human, Phase 1 Study. (PubMed, Target Oncol)
Thrombocytopenia and neutropenia limited repeat dosing. Although limited clinical activity was detected, the dose-escalation phase was stopped early without establishing an MTD. The study was registered with ClinicalTrials.gov (NCT03106428).
P1 data • Journal
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SLC1A5 (Solute Carrier Family 1 Member 5)
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MEDI7247
9d
Therapeutic plasma exchange as an intervention for gemtuzumab ozogamicin impaired hemoglobin scavenging: A case and systematic review. (PubMed, J Clin Apher)
Among reported cases, patients undergoing TPE and those receiving steroids had improved outcomes. Practitioners should be aware of this rare drug side-effect and the potential utility of TPE for these patients.
Clinical • Review • Journal
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CD33 (CD33 Molecule)
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CD33 positive
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Mylotarg (gemtuzumab ozogamicin)
9d
Trial primary completion date
|
CD20 (Membrane Spanning 4-Domains A1) • CD22 (CD22 Molecule)
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CD20 expression • CD22 positive
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clonoSEQ
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Rituxan (rituximab) • cytarabine • doxorubicin hydrochloride • cyclophosphamide • methotrexate • Besponsa (inotuzumab ozogamicin) • vincristine • prednisone • mercaptopurine • dexamethasone injection
12d
Glo-BNHL: A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
P2/3, N=210, Not yet recruiting, University of Birmingham | Trial completion date: Oct 2032 --> May 2033 | Initiation date: Oct 2023 --> May 2024 | Trial primary completion date: Oct 2030 --> May 2031
Trial completion date • Trial initiation date • Trial primary completion date
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carboplatin • Rituxan (rituximab) • ifosfamide • etoposide IV • dexamethasone • Zynlonta (loncastuximab tesirine-lpyl) • odronextamab (REGN1979)
12d
New P2 trial
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Venclexta (venetoclax) • cytarabine • cyclophosphamide • Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin) • vincristine • prednisone • mercaptopurine
13d
Sequencing of anti-CD19 therapies in the management of diffuse large B-cell lymphoma. (PubMed, Clin Cancer Res)
The anti-CD19 monoclonal antibody tafasitamab, paired with the immunomodulator lenalidomide, mediates antibody-dependent cellular toxicity and cellular phagocytosis; the antibody-drug conjugate loncastuximab tesirine delivers the DNA-cross-linking agent tesirine via CD19 binding and internalization; and CD19-directed chimeric antigen receptor T-cell therapy (CAR-T) products are engineered from autologous T cells. To date, clinical evidence on the effect of anti-CD19 therapy prior to CAR-T is restricted to small case series. Prospective studies and detailed analyses to understand how pre- and post-treatment CD19 expression correlates with clinical responses to subsequent CD19-directed therapy are needed to fully maximize treatment strategies.
Journal • IO biomarker
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CD19 (CD19 Molecule)
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CD19 expression
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lenalidomide • Zynlonta (loncastuximab tesirine-lpyl) • Monjuvi (tafasitamab-cxix)
14d
ZBTB16 inhibits DNA replication and induces cell cycle arrest by targeting WDHD1 transcription in lung adenocarcinoma. (PubMed, Oncogene)
The overexpression of both isoforms of WDHD1 significantly reversed the ZBTB16-mediated inhibition of lung adenocarcinoma proliferation and cell cycle. These studies suggest that ZBTB16 impedes the progression of lung adenocarcinoma by interfering with WDHD1 transcription, making it a potential novel therapeutic target in the management of lung adenocarcinoma.
Journal
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ZBTB16 (Zinc Finger And BTB Domain Containing 16)
16d
Extramedullary infiltration in pediatric acute myeloid leukemia: Results from the Therapeutically Applicable Research to Generate Effective Treatments (TARGET) initiative. (PubMed, Pediatr Blood Cancer)
EMI at diagnosis is an independent adverse prognostic risk factor for pediatric AML, and GO treatment potentially improves survival for patients with EMI at diagnosis.
Journal
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FLT3 (Fms-related tyrosine kinase 3) • NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A)
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KMT2A rearrangement • MLL rearrangement
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Mylotarg (gemtuzumab ozogamicin)
20d
Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia (clinicaltrials.gov)
P3, N=310, Suspended, Alliance for Clinical Trials in Oncology | Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
Trial completion date • Trial primary completion date
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ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • CD20 (Membrane Spanning 4-Domains A1) • CD22 (CD22 Molecule) • ITGB1 (Integrin Subunit Beta 1)
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CD20 positive • CD22 positive
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Rituxan (rituximab) • cytarabine • doxorubicin hydrochloride • cyclophosphamide • Besponsa (inotuzumab ozogamicin) • vincristine • daunorubicin • Oncaspar liquid (pegaspargase) • mercaptopurine • thioguanine
20d
IMGN632-0802: IMGN632 as Monotherapy or With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia (clinicaltrials.gov)
P1/2, N=218, Active, not recruiting, ImmunoGen, Inc. | Recruiting --> Active, not recruiting | Phase classification: P1b/2 --> P1/2
Enrollment closed • Phase classification
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IL3RA (Interleukin 3 Receptor Subunit Alpha)
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CD123 positive • IL3RA positive
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Venclexta (venetoclax) • azacitidine • decitabine • pivekimab sunirine (IMGN632)
20d
Phase II Study of the Combination of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin (MEGO) for Patients With Acute Myeloid Leukemia Refractory to Initial Standard Induction Therapy (clinicaltrials.gov)
P2, N=16, Active, not recruiting, Robert Redner, MD | Completed --> Active, not recruiting | Trial completion date: Feb 2023 --> Dec 2028
Enrollment closed • Trial completion date
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CD33 (CD33 Molecule)
|
CD33 expression
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etoposide IV • Mylotarg (gemtuzumab ozogamicin) • mitoxantrone
20d
Enrollment change • Combination therapy • Metastases
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AXL (AXL Receptor Tyrosine Kinase)
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gemcitabine • mipasetamab uzoptirine (ADCT-601)
21d
MGC018-SCLC: MGC018 in Patients With Relapsed or Refractory Extensive-Stage Small-Cell Lung Cancer (clinicaltrials.gov)
P2, N=17, Recruiting, Georgetown University | Not yet recruiting --> Recruiting
Enrollment open
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vobramitamab duocarmazine (MGC018)
23d
Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia (clinicaltrials.gov)
P2, N=89, Recruiting, Associazione Italiana Ematologia Oncologia Pediatrica | Trial completion date: Oct 2024 --> Oct 2027 | Trial primary completion date: Oct 2022 --> Oct 2025
Trial completion date • Trial primary completion date
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RARA (Retinoic Acid Receptor Alpha) • PML (Promyelocytic Leukemia)
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Mylotarg (gemtuzumab ozogamicin) • arsenic trioxide
26d
Journal
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TP53 (Tumor protein P53) • ABL1 (ABL proto-oncogene 1) • KMT2A (Lysine Methyltransferase 2A)
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MLL rearrangement
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Besponsa (inotuzumab ozogamicin)
27d
INO-FIRST: Retrospective Observational Study on Infective Complications and Outcome of Patients With ALL Treated With INO (clinicaltrials.gov)
P=N/A, N=158, Recruiting, Gruppo Italiano Malattie EMatologiche dell'Adulto | Not yet recruiting --> Recruiting
Enrollment open
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CD22 (CD22 Molecule)
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CD22 positive
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Besponsa (inotuzumab ozogamicin)
27d
A review of immunotargeted therapy for Philadelphia chromosome positive acute lymphoblastic leukaemia: making progress in chemotherapy-free regimens. (PubMed, Hematology)
Since 2000, targeted therapy combined with chemotherapy, represented by the tyrosine kinase inhibitor Imatinib, has become the first-line treatment for PH + ALL...More recently, some innovative immune-targeted therapy greatly improved the prognosis of PH + ALL, such as Blinatumomab and Inotuzumab Ozogamicin...These new therapeutic interventions are changing the treatment landscape for PH + ALL. In summary, this review discusses the current advancements in targeted therapeutic agents shift in the treatment strategy of PH + ALL towards using more tolerable chemotherapy-free induction and consolidation regimens confers better disease outcomes and might obviate the need for HSCT.
Review • Journal • IO biomarker
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ABL1 (ABL proto-oncogene 1)
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imatinib • Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)
28d
Gemtuzumab ozogamicin plus midostaurin in combination with standard '7 + 3' induction therapy in newly diagnosed AML: Results from the SAL-MODULE phase I study. (PubMed, Br J Haematol)
Three dose levels of midostaurin and one to three sequential doses of 3 mg/m2 GO in combination with '7 + 3' induction were evaluated. Based on safety findings in 12 patients, our results show that 3 mg/m2 GO on Days 1 + 4 and 100 mg midostaurin on Days 8-21 can be safely combined with IC in newly diagnosed AML.
P1 data • Journal • Combination therapy
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FLT3 (Fms-related tyrosine kinase 3)
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FLT3 mutation
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Rydapt (midostaurin) • Mylotarg (gemtuzumab ozogamicin)
29d
Antibody Drug Conjugate ADCT-701 in Neuroendocrine Tumors and Carcinomas (clinicaltrials.gov)
P1, N=70, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | Trial completion date: Oct 2028 --> Oct 2029 | Trial primary completion date: Oct 2026 --> Oct 2027
Enrollment open • Trial completion date • Trial primary completion date
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CD4 (CD4 Molecule)
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ADCT-701
29d
Tamarack: A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors (clinicaltrials.gov)
P2, N=382, Active, not recruiting, MacroGenics | N=100 --> 382 | Trial completion date: Dec 2026 --> May 2027 | Trial primary completion date: Dec 2026 --> May 2027
Enrollment change • Trial completion date • Trial primary completion date • Metastases
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abiraterone acetate • vobramitamab duocarmazine (MGC018)
30d
Enrollment open
|
KMT2A (Lysine Methyltransferase 2A) • CD22 (CD22 Molecule)
|
MLL rearrangement • CD22 expression
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cytarabine • cyclophosphamide • methotrexate • Besponsa (inotuzumab ozogamicin) • vincristine • leucovorin calcium • Oncaspar liquid (pegaspargase) • Asparlas (calaspargase pegol-mknl) • Starasid (cytarabine ocfosfate)
1m
CLAG-GO for Patients With Persistent, Relapsed or Refractory AML (clinicaltrials.gov)
P2, N=39, Recruiting, University of Maryland, Baltimore | Trial completion date: Feb 2025 --> Feb 2027 | Trial primary completion date: Jan 2024 --> Jun 2026
Trial completion date • Trial primary completion date
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CD33 (CD33 Molecule)
|
cytarabine • Mylotarg (gemtuzumab ozogamicin) • cladribine
1m
Trial completion date
|
CD4 (CD4 Molecule)
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azacitidine • Mylotarg (gemtuzumab ozogamicin)
1m
Genomic determinants of response and resistance to inotuzumab ozogamicin in B-cell ALL. (PubMed, Blood)
Our findings highlight the importance of defining the basis of CD22 escape, and eradication of residual disease prior to HSCT. The identified mechanisms of escape from CD22-targeted therapy extend beyond antigen loss, and provide opportunities to improve therapeutic approaches and overcome resistance.
Journal
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TP53 (Tumor protein P53) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A)
|
TP53 mutation • ATM mutation • CD22 expression
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Besponsa (inotuzumab ozogamicin)
1m
Talazoparib and Gemtuzumab Ozogamicin for the Treatment of CD33 Positive Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
P1, N=25, Recruiting, Roswell Park Cancer Institute | Active, not recruiting --> Recruiting
Enrollment open
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CD33 (CD33 Molecule)
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Talzenna (talazoparib) • Mylotarg (gemtuzumab ozogamicin)
2ms
Besponsa Post Marketing Surveillance Study (clinicaltrials.gov)
P=N/A, N=160, Active, not recruiting, Pfizer | N=100 --> 160
Enrollment change
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Besponsa (inotuzumab ozogamicin)
2ms
A Study of MGC018 in Combination With MGD019 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=278, Recruiting, MacroGenics | Trial completion date: Mar 2025 --> Mar 2026 | Trial primary completion date: Mar 2024 --> Mar 2025
Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition • Metastases
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vobramitamab duocarmazine (MGC018) • lorigerlimab (MGD019)
2ms
Enrollment closed
|
FLT3 (Fms-related tyrosine kinase 3)
|
Xospata (gilteritinib) • etoposide IV • methotrexate • Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation) • mitoxantrone • Rylaze (recombinant Erwinia asparaginase) • Kidrolase (L-asparaginase) • Leunase (L-asparaginase) • Spectrila (asparaginase Escherichia coli) • Starasid (cytarabine ocfosfate) • dexrazoxane
2ms
Inotuzumab in Older Patients with Newly Diagnosed Acute Lymphoblastic Leukemia-A Podcast. (PubMed, Target Oncol)
Several ongoing trials in older patients with newly diagnosed ALL have yielded encouraging data with inotuzumab ozogamicin in induction alone and in combination with low-intensity chemotherapy. In this podcast, the authors summarize and highlight some of the recent findings on the use of inotuzumab ozogamicin as induction therapy for older adults with newly diagnosed ALL.
Journal
|
TP53 (Tumor protein P53) • CD22 (CD22 Molecule)
|
TP53 mutation • CD22 positive
|
Besponsa (inotuzumab ozogamicin)
2ms
Pivekimab sunirine (IMGN632), a novel CD123-targeting antibody-drug conjugate, in relapsed or refractory acute myeloid leukaemia: a phase 1/2 study. (PubMed, Lancet Oncol)
Pivekimab sunirine showed single-agent activity across multiple doses, with a recommended phase 2 dose of 0·045 mg/kg once every 3 weeks. These findings led to a phase 1b/2 study of pivekimab sunirine plus azacitidine and venetoclax in patients with CD123-positive acute myeloid leukaemia.
P1/2 data • Clinical Trial,Phase II • Journal
|
CD123 (Interleukin 3 Receptor Subunit Alpha) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
|
CD123 positive • CD123 expression • IL3RA expression • IL3RA positive
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Venclexta (venetoclax) • azacitidine • pivekimab sunirine (IMGN632)
2ms
AALL1732: Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy (clinicaltrials.gov)
P3, N=4997, Recruiting, Children's Oncology Group | Trial completion date: Jun 2029 --> Mar 2030 | Trial primary completion date: Jun 2029 --> Mar 2030
Trial completion date • Trial primary completion date
|
cytarabine • doxorubicin hydrochloride • cyclophosphamide • methotrexate • Besponsa (inotuzumab ozogamicin) • vincristine • daunorubicin • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine • Asparlas (calaspargase pegol-mknl) • thioguanine • Hemady (dexamethasone tablets) • Starasid (cytarabine ocfosfate)
2ms
Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia (clinicaltrials.gov)
P1/2, N=44, Recruiting, Leland Metheny | Trial completion date: Jun 2025 --> May 2026 | Trial primary completion date: Dec 2023 --> May 2024
Trial completion date • Trial primary completion date • Post-transplantation
|
BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6) • CD22 (CD22 Molecule)
|
BCL6 rearrangement • CD22 positive • BCL2 rearrangement
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Besponsa (inotuzumab ozogamicin)
2ms
In relapsed or refractory diffuse large B-cell lymphoma, CD19 expression by immunohistochemistry alone is not a predictor of response to loncastuximab tesirine. (PubMed, EJHaem)
We found Lonca is an effective treatment for R/R DLBCL regardless of CD19 expression by immunohistochemistry. These results provide the basis for future studies addressing CD19-targeted agent sequencing.
Journal
|
CD19 (CD19 Molecule)
|
CD19 expression
|
Zynlonta (loncastuximab tesirine-lpyl)
2ms
Safety and long-term survival results of the addition of inotuzumab ozogamicin to the conditioning regimen of allogeneic stem cell transplantation: A single-center phase 1,2 trial. (PubMed, Am J Hematol)
One patient developed VOD; this patient had received nivolumab immediately before HSCT while simultaneously experiencing hyperacute graft-vs-host disease (GVHD). Patients with lymphoma who received INO had a trend for a better 5-year OS (93% versus 68%) and PFS (93% versus 58%) than those in the control group. In conclusion, our results showed that INO is safe with no increased risk of VOD when combined with one alkylator-containing regimen of HSCT.
P1/2 data • Journal
|
CD22 (CD22 Molecule)
|
Opdivo (nivolumab) • Besponsa (inotuzumab ozogamicin)
3ms
Bendamustine + Pomalidomide + Dex in R/R Multiple Myeloma (clinicaltrials.gov)
P1/2, N=56, Active, not recruiting, Cristina Gasparetto | Trial completion date: Jan 2023 --> Jan 2025
Trial completion date
|
pomalidomide • bendamustine
3ms
Trial primary completion date • Combination therapy
|
FLT3 (Fms-related tyrosine kinase 3) • CD33 (CD33 Molecule)
|
CD33 positive • CD33 expression
|
cytarabine • Rydapt (midostaurin) • Mylotarg (gemtuzumab ozogamicin) • daunorubicin • Starasid (cytarabine ocfosfate)
3ms
BESPONSA Injection 1 mg Special Investigation (clinicaltrials.gov)
P=N/A, N=200, Active, not recruiting, Pfizer | Trial completion date: May 2024 --> Sep 2024 | Trial primary completion date: May 2024 --> Sep 2024
Trial completion date • Trial primary completion date
|
Besponsa (inotuzumab ozogamicin)
3ms
Loncastuximab Tesirine in Combination With DA-EPOCH-R in Patients With Previously Untreated Aggressive B-cell Lymphoid Malignancies (clinicaltrials.gov)
P1, N=33, Recruiting, Medical College of Wisconsin | Trial completion date: May 2028 --> May 2026 | Trial primary completion date: May 2027 --> May 2026
Trial completion date • Trial primary completion date • Combination therapy
|
BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
|
MYC rearrangement • BCL6 rearrangement
|
Rituxan (rituximab) • cyclophosphamide • etoposide IV • pegylated liposomal doxorubicin • vincristine • prednisone • Zynlonta (loncastuximab tesirine-lpyl) • Marqibo (vincristine liposomal)
3ms
A041703: Inotuzumab Ozogamicin and Blinatumomab in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia (clinicaltrials.gov)
P2, N=64, Recruiting, National Cancer Institute (NCI) | Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025
Trial completion date • Trial primary completion date
|
ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • CD22 (CD22 Molecule)
|
CD22 positive • CD22 expression
|
Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)
3ms
INO-FIRST: Retrospective Observational Study on Infective Complications and Outcome of Patients With ALL Treated With INO (clinicaltrials.gov)
P=N/A, N=158, Not yet recruiting, Gruppo Italiano Malattie EMatologiche dell'Adulto | N=250 --> 158 | Trial completion date: Jun 2024 --> Nov 2024 | Initiation date: Nov 2023 --> Feb 2024 | Trial primary completion date: Jun 2024 --> Nov 2024
Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date
|
CD22 (CD22 Molecule)
|
CD22 positive
|
Besponsa (inotuzumab ozogamicin)
3ms
New trial
|
bortezomib • bendamustine • melphalan