Clinical trials: High Risk Leukaemia
Myelodysplastic Syndromes
Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic Syndromes
Evaluate the safety and efficacy of oral azacitidne (CC-486) twice daily (BID) in subjects with myelodysplastic syndromes who failed to achieve an objective response post injectable hypomethylating agent (iHMA) treatment Reason…
- Trial name
- NCT02281084
- Testing
- Oral Azacitidine, Durvalumab
- Where
- 89 sites in United States, Australia and 8 more
- Volunteers
- 65 people
- Sponsor
- Celgene
Myelodysplastic Syndromes, Acute Myeloid Leukemia
Study to Evaluate Imetelstat in Patients With High-Risk MDS or AML Failing HMA-based Therapy
The purpose of this study is to evaluate the efficacy, in terms of hematologic improvement, and safety of imetelstat in participants with high-risk (HR) myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) that is…
- Trial name
- IMpress (NCT05583552)
- Testing
- Imetelstat sodium
- Where
- 11 sites in Australia, France and 1 more
- Volunteers
- 46 people
- Sponsor
- GCP-Service International West GmbH
Acute Lymphoblastic Leukaemia, Acute Myeloid Leukaemia
Study of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression
The purpose of this study is to understand the safety, tolerability, efficacy, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of orally administered AZD3632 in participants with advanced haematologic…
- Conditions
- Acute Lymphoblastic Leukaemia, Acute Myeloid Leukaemia, Higher-risk Myelodysplastic Syndromes
- Trial name
- MOMENTUM (NCT07155226)
- Testing
- AZD3632, Posaconazole
- Where
- 30 sites in United States, Australia and 7 more
- Volunteers
- 85 people
- Sponsor
- AstraZeneca
Acute Myeloid Leukemia, Myelodysplastic Syndrome
A Study of BTX-A51 in People With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
This is an open-label, dose escalation study to evaluate the safety, toxicity, and pharmacokinetics (PK) as well as preliminary efficacy of BTX-A51 capsules in participants with relapsed or refractory acute myeloid leukemia (AML)…
- Trial name
- NCT04243785
- Testing
- BTX-A51, Azacitidine
- Where
- 3 sites in United States
- Volunteers
- 80 people
- Sponsor
- Edgewood Oncology Inc.
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
A Study of CC-90002 in Subjects With Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome (MDS)
Study CC-90002-AML-001 is an open-label, Phase 1 dose escalation (Part A) and expansion (Part B), clinical study of CC-90002, administered by intravenous (IV) infusion, in subjects with relapsed and/or primary refractory AML and…
- Trial name
- NCT02641002
- Testing
- CC-90002
- Where
- 6 sites in United States
- Volunteers
- 28 people
- Sponsor
- Celgene
Cancer
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.
- Trial name
- NCT00538850
- Testing
- Fentanyl sublingual spray
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- INSYS Therapeutics Inc
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
A Study of Cusatuzumab in Combination With Azacitidine Compared With Azacitidine Alone in Patients With Higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) and Who Are Not Candidates for Hematopoietic Stem Cell Transplantation (HSCT)
The purpose of the study is to compare overall response rate (ORR) between treatment groups in participants with higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) who are not eligible for…
- Trial name
- NCT04264806
- Testing
- Azacitidine, Cusatuzumab
- Where
- 73 sites in Australia, Brazil and 9 more
- Sponsor
- Janssen Research & Development, LLC
AML and High Risk MDS
A Safety and Efficacy Study of LGH447 in Patients With Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)
This study will assess the safety and preliminary efficacy of escalating doses of LGH447 monotherapy in AML and MDS and LGH447 in combination with midostaurin in AML.
- Trial name
- NCT02078609
- Testing
- LGH447, LGH447 + midostaurin
- Where
- 9 sites in United States, Australia and 5 more
- Volunteers
- 70 people
- Sponsor
- Novartis Pharmaceuticals
High Risk Hematological Malignancy, Cord Blood Transplant
US Study of UM171-Expanded CB in Patients With High Risk Leukemia/Myelodysplasia
Cord blood (CB) transplants are an option for patients lacking an HLA identical donor but are hampered by low cell dose, prolonged aplasia and high transplant related mortality.
- Trial name
- NCT04103879
- Testing
- ECT-001-CB (UM171-Expanded Cord Blood Transplant)
- Where
- 3 sites in United States, Netherlands
- Volunteers
- 30 people
- Sponsor
- ExCellThera inc.
Leukemia, Myeloid, Acute
BI 836858 Dose Escalation in Patients With Refractory or Relapsed Acute Myeloid Leukemia and in Patients With AML in Complete Remission With High Risk to Relapse
Patients with acute myeloid leukemia who experience a relapse after at least one prior regimen may be enrolled in this trial. In addition, acute myeloid leukemia patients who are in complete remission with high risk to relapse…
- Trial name
- NCT01690624
- Testing
- BI 836858
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Boehringer Ingelheim
Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma
Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With Relapsed or Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (R/R B-NHL)
The trial is an open-label, multi-center safety and preliminary efficacy trial of epcoritamab (EPKINLY™) in Japanese participants with relapsed, progressive or refractory B-cell lymphomas and Japanese participants with B-cell…
- Conditions
- Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma, Primary Mediastinal Large B Cell Lymphoma, Follicular Lymphoma
- Trial name
- EPCORE™ NHL-3 (NCT04542824)
- Testing
- Epcoritamab (monotherapy), Epcoritamab, Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
- Where
- 15 sites in Japan
- Volunteers
- 78 people
- Sponsor
- Genmab
Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed/Refractory B-cell Non-Hodgkin Lymphoma or CLL/SLL
Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies
Phase 1/2 umbrella study evaluates biomarker-selected dual-target CAR-T cell modules for adults with relapsed or refractory hematologic malignancies.
- Conditions
- Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed/Refractory B-cell Non-Hodgkin Lymphoma or CLL/SLL, Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia, Relapsed/Refractory Acute Myeloid Leukemia, High-risk Myelodysplastic Neoplasm
- Trial name
- ADAPT-HEM (NCT07523555)
- Testing
- Autologous CD19/CD22 dual-target CAR-T module, Autologous CD19/CD20 dual-target CAR-T module, Autologous BCMA/CD19 dual-target CAR-T module
- Where
- China
- Volunteers
- 96 people
- Sponsor
- Beijing Biotech
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
An Efficacy and Safety Study of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Adults With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly Patients With Acute Myeloid Leukemia (AML)
The primary objective of this study is to evaluate the efficacy of subcutaneous azacitidine in combination with durvalumab as compared with subcutaneous azacitidine alone in adults with previously untreated, higher risk MDS who…
- Trial name
- NCT02775903
- Testing
- Azacitidine, Durvalumab
- Where
- 103 sites in United States, Austria and 10 more
- Volunteers
- 213 people
- Sponsor
- Celgene
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
Acute Myeloid Leukaemia, High Risk Myelodysplastic Syndrome
Phase 1 Open-label Study of AMX-883 Alone in Participants With AML and High-risk MDS and in Combination in Participants With AML
The purpose of the study is to assess the safety, pharmacokinetics, and preliminary efficacy of AMX-883 monotherapy in participants with acute myeloid leukaemia (AML) and high-risk myelodysplastic syndrome (MDS) and in…
- Trial name
- BRAMLIE (NCT07723703)
- Testing
- AMX-883, Posaconazole
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Amphista Therapeutics Ltd
Relapsed Non Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
A Study to Evaluate VIP152 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Richter Syndrome
Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of VIP152 as monotherapy or in combination with a BTKi in patients with Chronic Lymphocytic Leukemia (CLL) or…
- Conditions
- Relapsed Non Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia, Richter Syndrome
- Trial name
- NCT04978779
- Testing
- VIP152, BTKi
- Where
- 5 sites in United States, Poland
- Volunteers
- 6 people
- Sponsor
- Vincerx Pharma, Inc.
AML, MDS
Study of APVO436 in Patients With AML or MDS
The primary objective of the Phase 1 part of the study is to determine the recommended dose of APVO436 administered intravenously to patients with AML or MDS.
- Trial name
- NCT03647800
- Testing
- APVO436
- Where
- 12 sites in United States
- Volunteers
- 136 people
- Sponsor
- Aptevo Research and Development LLC
High Risk Acute Myeloid Leukemia
Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia
To confirm the efficacy of CPX-351 compared to 7+3 as first line therapy in elderly patients (60-75 yrs) with high risk (secondary) Acute Myeloid Leukemia. The primary efficacy endpoint will be overall survival.
- Trial name
- 301 (NCT01696084)
- Testing
- CPX-351, 7+3 (cytarabine and daunorubicin)
- Where
- 43 sites in United States, Canada
- Volunteers
- 309 people
- Sponsor
- Jazz Pharmaceuticals
Chronic Myelogenous Leukemia, Ph1-Positive, Acute Myeloid Leukemia
Clinical Trial of BP1001 (Liposomal Grb2 Antisense Oligonucleotide) in Combination With Dasatinib in Patients With Ph + CML Who Have Failed TKI, Ph+ AML, Ph+ MDS
The primary objective of the Phase Ib study is to determine the dose-limiting toxicity (DLT) and maximal tolerated dose (MTD) of BP1001 in combination with dasatinib in patients with with Philadelphia Chromosome Positive (Ph+)…
- Conditions
- Chronic Myelogenous Leukemia, Ph1-Positive, Acute Myeloid Leukemia, Myelodysplastic Syndrome
- Trial name
- NCT02923986
- Testing
- BP1001 (varying dose), BP1001 (fixed dose), Dasatinib
- Where
- United States
- Sponsor
- Bio-Path Holdings, Inc.
Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML)
Pharmacokinetics, Tolerability and Safety of NEX-18a
The study will evaluate the safety, tolerability and pharmacokinetics of NEX-18a, a long-acting injectable azacitidine, in patients diagnosed with intermediate 2 or higher-risk MDS, CMML, or AML and already on treatment with…
- Conditions
- Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), Acute Myeloid Leukemia (AML)
- Trial name
- NCT05048498
- Testing
- NEX-18a injection, Azacitidine Injection
- Where
- 2 sites in Sweden
- Volunteers
- 2 people
- Sponsor
- Nanexa AB