Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Philadelphia Chromosome

Leukemia, Myeloid, Chronic-Phase

Leukemia, Myeloid, Accelerated Phase

Blast Crisis

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Translocation, Genetic

Chromosome Aberrations

Cell Transformation, Neoplastic

Carcinogenesis

Neoplastic Processes

Myeloid Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Acute Graft Versus Host Disease

Lymphosarcoma

Chronic Myeloproliferative Disorders

All Drugs and Chemicals

Amino Acids

Tyrosine Kinase Inhibitors

Tyrosine

Participants with CML and Ph+ALL who are being treated with their first or subsequent TKI therapy. CML patients must meet the ELN criteria for warning and failure ) or have high SOKAL score (\>0.8) or presence of additional chromosomal abnormalities (ACAs) and have detectable BCR-ABL levels. Ph+ALL patients need detectable BCR-ABL levels only.

Michael Thompson, MD

A multicenter, prospective cohort study of the mutation status of patients with chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) who are being treated with first or subsequent tyrosine kinase inhibitor (TKI) therapy in the UK, Ireland, or France.

CALLS: CML and Ph+ALL Low Level Mutation Prevalence Survey

A Cohort Study To Establish the Prevalence of Mutations in Patients With CML Who Meet the ELN Criteria for Warning or Failure and Patients With Ph+ ALL With Detectable BCR-ABL Currently Being Treated With First or Subsequent TKI Therapy in the UK, Ireland, or France Using Next-Generation Sequencing

Blood samples will be identifiable by a code consisting of numbers and initials. Samples may be stored and tested for up to 5 years after the completion of the study.

Participants in all phases of CML (CP, AP, and BP) will be enrolled.

All samples will be processed by NGS. BCR-ABL levels defined as \> 0.1% to 1% international scale (IS), \> 1% to 10% IS, \> 10% IS.

Incyte Biosciences UK

Antineoplastic Agents

Gastrointestinal Agents

Micronutrients

Vasodilator Agents

Lipid Regulating Agents

Hematinics

Vitamins

Asciminib

Bosutinib

Nilotinib

Dasatinib

Imatinib Mesylate

Lactitol

Niacinamide

Niacin

Nicotinic Acids

Protein Kinase Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Trace Elements

Nicotinamide

Nicotinic Acid

Vitamin B3

Folate

Vitamin B9

Participants with CML or ALL, from Novartis sponsored asciminib studies, including but not limited to ABL001A2301, ABL001A2302, ABL001X2101, ABL001A2202, ABL001AUS04 and ABL001AUS08 studies, that were receiving asciminib

Participants with CML-CP, from Novartis sponsored asciminib study ABL001A2301, that were receiving bosutinib

Participants with CML-CP, from Novartis sponsored asciminib study ABL001A2301 that were receiving bosutinib treatment and switched to asciminib when entering this study or during the course of this study

Participants with CML from Novartis sponsored asciminib studies ABL001E2201 or CABL001X2101 that were receiving asciminib combined with imatinib

Participants with CML or ALL from Novartis sponsored asciminib studies ABL001E2201or CABL001X2101 that were receiving asciminib combined with nilotinib

Participants with CML-CP, from Novartis sponsored asciminib study ABL001E2201 that were receiving imatinib

Participants with CML-CP, from Novartis sponsored asciminib study ABL001E2201 that were receiving nilotinib

Participants with CML from Novartis sponsored study ABL001X2101 that were receiving asciminib with dasatinib

Taken orally, twice daily (BID) or once daily (QD), in fasting state

Asciminib single agent

Taken orally, once daily, in the morning with low-fat meal or twice daily in fasting state

Taken orally, once daily, in the morning with low-fat meal

Imatinib

Taken orally, twice daily, on an empty stomach

Taken orally, once daily in a fasted state, 1 or 2 hours before a meal

Novartis Pharmaceuticals

Moshe Talpaz

Dalisa Espinosa

Michael Mauro

Koji Sasaki

This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment

This is an open-label, multi-center, global roll-over study designed to assess long term safety and provide continued treatment to participants who have previously participated in an asciminib Novartis sponsored study and who, in the opinion of the investigator, would benefit from continued treatment as in the parent study, or from switching to asciminib (if they were on bosutinib in the parent study), but are unable to access this treatment outside of the clinical study.

Asciminib Roll-over Study

An Open Label, Multi-center Asciminib Roll-over Study to Assess Long-term Safety in Patients Who Have Completed a Novartis Sponsored Asciminib Study and Are Judged by the Investigator to Benefit From Continued Treatment

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

All AEs and SAEs will be tabulated and listed for participants in the Safety Set by treatment group. From day of first administration of study treatment to 30 days after the last study treatment.

Investigators' assessment of clinical benefit will collected through the Investigator confirming that the patient is still benefiting from treatment. This will be evaluated and tabulated for participants in the Safety Set by treatment group at each visit.

Central Nervous System Depressants

Other Dietary Supplements

Homoharringtonine

Benzocaine

Tannic Acid

Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m\^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.

Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m\^2 by continuous 24-hour intravenous (IV) infusion daily on Days 1-5 of each 4 week treatment cycle. Participants who do not achieve a meaningful hematologic or cytogenetic response by the end of the fourth cycle are discontinued from the study. Otherwise, participants may continue additional cycles of this combined treatment for a maximum of 12 cycles.

Participants who achieved a molecular or cytogenetic response, or a complete hematologic remission (CHR), could undergo subsequent cycles with a maintenance schedule of homoharringtonine 2.5 mg/m\^2 by continuous 24-hour IV infusion daily for 2 days every 4 weeks. Dose escalations in subsequent cycles were allowed by one day at a time if the participant was unable to maintain CHR in the maintenance schedule.

Taken by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML. For the first cycle of therapy only, imatinib was started on Day 4 of homoharringtonine treatment.

Adam R Craig, M.D., PhD

Jorge Cortes, M.D.

This will be an open label, multi-center study of up to 77 patients with CML in chronic, accelerated or blast phase who have developed resistance to or have failed previous treatment with Gleevec (imatinib mesylate). Because these patients may still be sensitive to Gleevec, adding Homoharringtonine may restore a response to Gleevec or the combined treatment may promote a better response than using Gleevec alone.

Every 4 weeks, the study medicine Homoharringtonine will be given by vein daily for 5 days along with continuing daily doses of the approved medicine Gleevec taken by mouth. The safety and effectiveness of this combined treatment in CML patients will be studied. Patients who do not achieve a meaningful hematologic or cytogenetic response after 4 cycles or less will be discontinued. Otherwise, patients may continue additional cycles of this combined treatment for a maximum of 12 cycles.

Homoharringtonine With Oral Gleevec in Chronic, Accelerated and Blast Phase Chronic Myeloid Leukemia (CML)

A Phase II Open-Label Study of the Intravenous Administration of Homoharringtonine (CGX-635) Combined With the Oral Administration of Gleevec in the Treatment of Patients With Chronic Myeloid Leukemia (CML) in Chronic, Accelerated, and Blast Phase

Participants in accelerated or blast phase who converted to at least CML-chronic phase.

CML in accelerated phase meets one or more of the following criteria: \>=15% - \<30% blasts in peripheral blood or bone marrow, \>=30% blasts + promyelocytes in peripheral blood or bone marrow, \>=20% basophils in peripheral blood; platelet count \<100\*10\^9/L unrelated to therapy or clonal evolution. CML in blast phase have \>=30% blasts in the bone marrow or presence of extramedullary disease.

Meaningful responses include (in descending order of health)

* Complete Hematologic Remission (CHR)
* Partial Hematologic Remission (PHR)
* Hematologic Improvement (HI)
* Partial Response (PR)
* Return to Chronic Phase (RCP). A return to chronic phase involves the disappearance of blastic phase features and a return to chronic phase CML picture, i.e., peripheral blasts \<15%, peripheral blasts and promyelocytes \<30%, peripheral basophils \<20%, and platelets \>100\*10\^9/L.

Participants who are not in complete hematologic remission (CHR) at study start must achieve at least a CHR, and participants who are in CHR at onset must demonstrate an improvement in their cytogenetics.

A Complete Hematologic Remission (CHR) involves normalization of the bone marrow (less than 5% blasts) and peripheral blood with white blood cells \< 10\*10\^9/L, absolute neutrophil count \>=1\*10\^9/L, platelets \>=100\*10\^9/L and no peripheral blasts, promyelocytes or myelocytes. This is in addition to disappearance of all signs and symptoms of the disease.

Summary of participants who had adverse events (AEs), who discontinued treatment due to the AE, who had serious adverse events (SAEs), and who had SAEs that were related to treatments.

A serious adverse event is one that at any dose of the study drug or at any time during the period of observation:

* Results in death;
* Is life threatening;
* Requires inpatient hospitalization or prolongation of existing hospitalization;
* Results in persistent or significant disability/incapacity;
* Is a congenital anomaly/birth defect;
* Is medically important.

The Investigator assessed each AE for potential causal relationship between the event and study drug. An investigator assessment of possibly, probably or unknown relation is considered related.

Complete hematologic remission was further classified according to the suppression of the Philadelphia chromosome (Ph) as:

No cytogenetic response - Ph positive 100% Minimal cytogenetic response - Ph positive 35-90% Partial cytogenetic response - Ph positive 1-34% Complete cytogenetic response - Ph positive 0%

ChemGenex Pharmaceuticals

Homoharringtonine + Imatinib Mesylate

Age, Continuous

Sex: Female, Male

Black

Caucasian

Hispanic

Race/Ethnicity, Customized

This study was intended to follow a Simon two stage design to test 18 patients in each stratum (chronic, accelerated and blast phase) for efficacy. Only 15 were enrolled, an insufficient number for a formal statistical analysis of efficacy.

Director, Clinical Research

No participants were analyzed since the study was intended to follow a Simon two stage design to test 18 participants in each stratum (chronic, accelerated and blast phases) for efficacy. Enrollment was insufficient.

Proportion of Participants With Accelerated Phase or Blast Phase Chronic Myeloid Leukemia (CML) Who Achieve a Meaningful Response

Proportion of Participants With Chronic Phase Chronic Myeloid Leukemia (CML) Who Achieve a Meaningful Response

Discontinued due to AE

Serious AEs

SAEs considered related

Number of Participants With Adverse Experiences (AEs)

Participants With Complete Hematologic Remission Suppression of the Philadelphia Chromosome

Overall Study

Blinatumomab

Ascentage Pharma HQP1351 bioavailable inhibitor

Administered in all patients as a continuous IV infusion at the dosage of 28μg daily (9μg daily for Cycle 1 Day 1 to Day 7).

Bill Garrett

Sarah Weaver

Omer Jamy, MD

London Hall

Thad Beck, MD

Paul Koller, MD

Shannon Gleason

Anthony Hunter, MD

Amelia Barkman

Maria Baer, MD

Erik Lewerenz

Sudipto Mukherjee, MD

Jovitta Jacob

Elias Jabbour, MD

Kaysey Orlowski

Vivian Oehler, MD

Yifan Zhai, MD, PhD

A multi-center, open-label, randomized, phase Ib study to evaluate the pharmacokinetics (PK) of HQP1351 and to determine the recommended phase 2 dose (RP2D) of HQP1351 in subjects with CML chronic phase (CP), accelerated phase (AP), or blast phase (BP) or with Ph+ ALL, who have experienced resistance or intolerance to at least two tyrosine kinase inhibitors (TKIs) or in subjects with Ph+ B-cell precursor (BCP) ALL or lymphoid blast phase CML (CML LBP), who have experienced resistance or intolerance to at least one second or later generation TKI.

Approximately 40 patients will be randomized at 3:3:2 ratio into one of three HQP1351 monotherapy dose cohorts (Cohort A, B, and C): 30 mg every other day (QOD), 40 mg QOD, and 50 mg QOD, with 15, 15, and 10 patients in Cohort A, B, and C. The first cycle of 28 days is considered as the dose-limiting toxicity (DLT) observation period. If the incidence of DLTs exceeds 20% (2 patients) in 50 mg dose cohort during the first cycle of therapy, this dose cohort will be stopped. The randomization will be stratified to 4 groups: T315I mutated CML-CP and CML-AP, T315I un-mutated CML-CP, T315I unmutated CML-AP, and CML-BP and Ph+ ALL to ensure that the subgroups are represented across all dose cohorts. Blood samples will be collected from each subject at specified time points to evaluate the PK of HQP1351. RP2D of HQP1351 will be determined based on the comprehensive analyses of the PK, safety, and efficacy data of the US patients treated with HQP1351, when compared with that in the Chinese patients.

Eligible patients will have disease resistance to or intolerance to at least two TKIs, for patients with T315I mutation, number of pretreated TKIs is not restricted. Patients will be administered HQP1351 orally QOD during a period of 28 days (1 cycle).

Cohort D (HQP1351 + blinatumomab) will enroll patients with relapsed/refractory Ph+ BCP ALL or CML-BP using a dose escalation and expansion design. Patients will be administered HQP1351 orally QOD at an assigned dose with blinatumomab at repeated 42-day cycles. The first cycle of 42 days is considered as the DLT observation period. The initial dose of HQP1351 will be 30 mg QOD.

A total of 40 patients will be randomized at 3:3:2 ratio into one of the three dose cohorts (Cohorts A, B, and C): 30 mg every other day (QOD), 40 mg QOD and 50 mg QOD, with 15, 15, and 10 patients in Cohort A, B, and C.

For Cohort D: 14 to 22 Ph+ BCP ALL or CML LBP patients will be enrolled.

Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL

A Phase Ib Study of the Pharmacokinetics, Safety and Efficacy of Orally Administered HQP1351 in Subjects With Refractory Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)

To evaluate the Maximum Plasma Concentration (Cmax) of HQP1351

To evaluate the Area Under the Curve (AUC) of HQP1351

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CALLS: CML and Ph+ALL Low Level Mutation Prevalence Survey	NCT03647215	Chronic Phase C... Accelerated Pha... Blastic Phase C... Philadelphia Ch...		18 Years -	Incyte Corporation
Asciminib Roll-over Study	NCT04877522	Chronic Myeloge... Leukemia, Myelo...	Asciminib singl... Asciminib Imatinib Nilotinib Bosutinib Dasatinib	18 Years -	Novartis
Homoharringtonine With Oral Gleevec in Chronic, Accelerated and Blast Phase Chronic Myeloid Leukemia (CML)	NCT00114959	Myeloid Leukemi... Myeloid Leukemi... Blast Phase Myeloid Leukemi...	Homoharringtoni... Imatinib Mesyla...	16 Years -	Teva Branded Pharmaceutical Products R&D, Inc.
Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL	NCT04260022	Leukemia, Myelo... Myeloid Leukemi... Chronic Myeloid... Philadelphia Po... B Cell Precurso...	Ascentage Pharm... Blinatumomab	18 Years -	Ascentage Pharma Group Inc.
Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL	NCT04260022	Leukemia, Myelo... Myeloid Leukemi... Chronic Myeloid... Philadelphia Po... B Cell Precurso...	Ascentage Pharm... Blinatumomab	18 Years -	Ascentage Pharma Group Inc.
Asciminib Roll-over Study	NCT04877522	Chronic Myeloge... Leukemia, Myelo...	Asciminib singl... Asciminib Imatinib Nilotinib Bosutinib Dasatinib	18 Years -	Novartis

Spots Global Cancer Trial Database for blast phase

Every month we try and update this database with for blast phase cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for blast phase

Every month we try and update this database with for blast phase cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for blast phase cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.