Clinical trials: Newly Diagnosed
Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL)
Pharmacokinetic and Pharmacodynamic Assessment of Treatment With CPX-351 (Cytarabine: Daunorubicin) Liposome for Injection in Acute Leukemias and MDS Patients With Moderate Hepatic Impairment
To assess the impact of moderate hepatic impairment on cytarabine and daunorubicin pharmacokinetics and their metabolites following administration of CPX-351.
- Conditions
- Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS)
- Trial name
- NCT02269579
- Testing
- CPX-351
- Where
- 5 sites in United States
- Sponsor
- Jazz Pharmaceuticals
Multiple Myeloma
Study Comparing Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone (D-RVd) Versus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Subjects With Newly Diagnosed Multiple Myeloma
The purpose of this study is to determine if the addition of daratumumab to lenalidomide-bortezomib-dexamethasone (RVd) will increase the proportion of participants achieving stringent complete response (sCR), as defined by the…
- Trial name
- NCT02874742
- Testing
- Lenalidomide, Bortezomib, Dexamethasone
- Where
- 36 sites in United States
- Volunteers
- 224 people
- Sponsor
- Janssen Research & Development, LLC
Mantle Cell Lymphoma
A Study of Parsaclisib, a PI3Kδ Inhibitor, in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma
This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study of parsaclisib plus BR versus placebo plus BR as first-line treatment of participants with newly diagnosed MCL.
- Trial name
- CITADEL-310 (NCT04849715)
- Testing
- parsaclisib, rituximab, bendamustine
- Sponsor
- Incyte Corporation
Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation
A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy
This was a clinical study for adult participants who were recently diagnosed with acute myeloid leukemia or AML. AML is a type of cancer. It is when bone marrow makes white blood cells that are not normal.
- Trial name
- NCT02752035
- Testing
- gilteritinib, azacitidine
- Where
- 111 sites in United States, Australia and 11 more
- Volunteers
- 183 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)
Phase 2 Study of Azacitidine (Vidaza) vs MGCD0103 vs Combination in Elderly Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
The purpose of the study is to determine how effective azacitidine, MGCD0103, and the combination of azacitidine and MGCD0103 are in treating AML or MDS in people over 60 years of age.
- Trial name
- NCT00666497
- Testing
- Azacitidine, MGCD0103
- Where
- 8 sites in United States, Canada and 1 more
- Volunteers
- 6 people
- Sponsor
- Mirati Therapeutics Inc.
Epilepsy
Clinical Study of Lamotrigine to Treat Newly Diagnosed Epilepsy
This is a multi-center, uncontrolled, open-label study conducted in Japan and South Korea to evaluate the efficacy and safety of lamotrigine monotherapy in subjects with newly diagnosed epilepsy and those with recurrent epilepsy…
- Trial name
- NCT01431963
- Testing
- Lamictal
- Where
- 13 sites in Japan, South Korea
- Volunteers
- 70 people
- Sponsor
- GlaxoSmithKline
Acute Promyelocytic Leukemia (APL), Acute Promyelocytic Leukaemia
Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
This Phase 3 study in adult participants with newly diagnosed low-risk APL will evaluate the efficacy, safety, and PK of an oral capsule formulation of ATO, in combination with ATRA.
- Conditions
- Acute Promyelocytic Leukemia (APL), Acute Promyelocytic Leukaemia, Acute Promyelocytic Leukemia With PML-RARA, Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA
- Trial name
- QUATRO-APL (NCT07504458)
- Testing
- QTX-2101 + ATRA, IV arsenic trioxide (ATO) + ATRA
- Where
- 36 sites in United States, France and 3 more
- Volunteers
- 150 people
- Sponsor
- Quetzal Therapeutics
Glioblastoma
Safety and Efficacy of L19TNF Plus Temozolomide Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma
The purpose of this study is to explore the safety profile and establish a recommended dose (RD) for phase II of the antibody-cytokine fusion protein L19TNF plus standard TMZ chemoradiotherapy in patients with newly diagnosed…
- Trial name
- GLIOSUN (NCT04443010)
- Testing
- Onfekafusp alfa, Temozolomide
- Where
- Switzerland
- Volunteers
- 226 people
- Sponsor
- Philogen S.p.A.
Mycobacterium Infections, Nontuberculous
Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
The primary objective of this study is to generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the…
- Trial name
- ARISE (NCT04677543)
- Testing
- ALIS, Azithromycin, Ethambutol
- Where
- 62 sites in United States, Argentina and 10 more
- Volunteers
- 99 people
- Sponsor
- Insmed Incorporated
Glioblastoma
Temozolomide in Concomitant Radiochemotherapy Followed by Sequential Temozolomide Chemotherapy - Observational Program (Study P04816)
The purpose of this program is to evaluate the safety, tolerability, and efficacy of the new concomitant and sequential temozolomide regimen in newly diagnosed Glioblastoma patients in a routine care setting.
- Trial name
- NCT00725010
- Testing
- Temozolomide, Radiotherapy
- Volunteers
- 64 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Myelogenous Leukemia in Chronic Phase
Efficacy, Safety and Long-term Prognosis of Imatinib in Patients Newly Diagnosed With Chronic Myelogenous Leukemia (Chronic Phase)
This study will assess the safety and efficacy of imatinib in newly enrolled previously untreated patients with chronic phase CML.
- Trial name
- NCT00237120
- Testing
- Imatinib
- Volunteers
- 100 people
- Sponsor
- Novartis
CML in Chronic Phase
Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome & /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase
This study will assess the efficacy and safety of nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive/BCR-ABL positive chronic myeloid leukaemia in chronic phase.
- Trial name
- 'MACS1252 (NCT01061177)
- Testing
- Nilotinib
- Where
- 320 sites in Austria, Belgium and 24 more
- Volunteers
- 1,090 people
- Sponsor
- Novartis Pharmaceuticals
Focal Onset Seizure
Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy
Cenobamate (YKP3089) is a small molecule approved in the United States (US), Europe and several other countries around the world for the treatment of Partial-Onset (focal) seizures in adult subjects (≥18 years of age).
- Trial name
- NCT06453213
- Testing
- Cenobamate
- Where
- 19 sites in United States
- Volunteers
- 49 people
- Sponsor
- SK Life Science, Inc.
Relapsed/Refractory Multiple Myeloma (RRMM), Metastatic Colorectal Cancer (mCRC)
Study of the Safety, Tolerability and Efficacy of KPT-8602 in Participants With Relapsed/Refractory Cancer Indications
This is a first-in-human, multi-center, open-label clinical study with separate dose escalation (Phase 1) and expansion (Phase 2) stages to assess preliminary safety, tolerability, and efficacy of the second generation oral XPO1…
- Conditions
- Relapsed/Refractory Multiple Myeloma (RRMM), Metastatic Colorectal Cancer (mCRC), Metastatic Castration-Resistant Prostate Cancer (mCRPC), Higher-Risk Myelodysplastic Syndrome (HR-MDS)
- Trial name
- NCT02649790
- Testing
- KPT-8602, ASTX727, Dexamethasone
- Where
- 46 sites in United States, Canada and 3 more
- Volunteers
- 277 people
- Sponsor
- Karyopharm Therapeutics Inc
Chronic Myeloid Leukemia, Philadelphia Chromosome
Study of Chinese Newly Diagnosed Participants With Philadelphia Chromosome-Positive (Ph+) Chronic Myeloid Leukemia in Chronic Phase (CML-CP)
Observational medical record review of newly diagnosed CML-CP participants in China
- Conditions
- Chronic Myeloid Leukemia, Philadelphia Chromosome, Chronic Myeloid Leukemia in Chronic Phase
- Trial name
- NCT03509896
- Testing
- Non-Interventional
- Where
- China
- Volunteers
- 463 people
- Sponsor
- Bristol-Myers Squibb
Mycobacterium Infections, Nontuberculous
Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
The main objective of this study is to evaluate the efficacy of ALIS (amikacin liposome inhalation suspension) + background regimen (azithromycin [AZI] + ethambutol [ETH]) compared to the ELC (empty liposome control) + background…
- Trial name
- ENCORE (NCT04677569)
- Testing
- ALIS, Azithromycin, Ethambutol
- Where
- 258 sites in United States, Argentina and 21 more
- Volunteers
- 425 people
- Sponsor
- Insmed Incorporated
Amyloidosis
A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Cyclophosphamide, Bortezomib, and Dexamethasone in Adult Participants With Newly Diagnosed Amyloid Light Chain (AL) Amyloidosis
The study aims to evaluate the efficacy and safety of belantamab mafodotin in combination with cyclophosphamide, bortezomib, and dexamethasone in adult participants with newly diagnosed (ND) AL amyloidosis .
- Trial name
- ALANIS (NCT07224672)
- Testing
- Belantamab mafodotin, Cyclophosphamide, Bortezomib
- Where
- 16 sites in United States, Australia and 1 more
- Volunteers
- 60 people
- Sponsor
- GlaxoSmithKline
Multiple Myeloma
IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma
The purpose of this study is to provide continued access to ixazomib and/or lenalidomide to participants who are continuing to have clinical benefit and to continue collecting relevant safety data to monitor safety in…
- Trial name
- NCT01850524
- Testing
- Ixazomib, Dexamethasone, Lenalidomide
- Where
- 147 sites in United States, Belgium and 5 more
- Volunteers
- 705 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Glioblastoma (GBM)
A Phase 1/2 Study of the Safety and Tolerability of MT-125 in GBM Patients
The purpose of the study is to determine the recommended dose and further understand the safety of MT-125 in participants who have been diagnosed with glioblastoma, a primary brain tumor, when administered in combination with…
- Trial name
- STAR-GBM (NCT07185880)
- Testing
- MT-125
- Where
- 3 sites in United States
- Volunteers
- 36 people
- Sponsor
- Myosin Therapeutics Inc.
Leukemia, Myeloid, Acute
Survival in Patients Older Than 60 Years With Newly Diagnosed AML in Spain
Prospective, multicenter, observational, national study (EPA-SP) that aims to describe the survival and the quality of life, the clinical management strategies and the prognostic factors for survival related to the patient, in a…
- Trial name
- NCT03435341
- Where
- 40 sites in Spain
- Volunteers
- 151 people
- Sponsor
- Celgene