A Phase 1 interventional study of Asciminib and Biospecimen Collection in B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, sponsored by City of Hope Medical Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by City of Hope Medical Center · Phase 1, Interventional, and Treatment
Among 55 studies in Precursor Cell Lymphoblastic Leukemia-Lymphoma by City of Hope Medical Center — 10 open to participants now, 27 under way, none of them phase 3. Precursor Cell Lymphoblastic Leukemia-Lymphoma · City of Hope Medical Center.
Among the 55 studies in Precursor Cell Lymphoblastic Leukemia-Lymphoma by City of Hope Medical Center, this one is the 36th largest by planned enrollment of the 50 interventional ones that give a count, is the only one that started in 2027, is one of 22 in phase 1, reaches primary completion later than 19 of the 26 other live ones, and was the 55th registered.
2,584 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 473 are open to participants now.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →10 of the 55 studies in Precursor Cell Lymphoblastic Leukemia-Lymphoma by City of Hope Medical Center are open now, in 1 country. Recruiting first, the newest first:
City of Hope Medical Center · Sites in United States
Ages 18–75 · Healthy volunteers
City of Hope Medical Center · Sites in United States
Ages 18+
City of Hope Medical Center · Sites in United States
Ages 18+
City of Hope Medical Center · Sites in United States
Ages 18–54
City of Hope Medical Center · Sites in United States
Ages 18–70
By country, each count listing its studies:
Of the 370 Precursor Cell Lymphoblastic Leukemia-Lymphoma studies recruiting now, 96 (26%) set no upper age limit and 257 (69%) stop at 75 or younger; 247 take children under 18; 29 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
55 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 26 · Phase 2 20
First in 2000; this study’s year is marked. 1 started in 2027.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 21 is below the median of 40 across 1,952 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Median enrollment 33 across the 50 interventional studies, 153 across the 5 observational. Of the 24 that completed or were terminated, 8 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
City of Hope Medical Center is the lead sponsor of 677 studies on the registry; 181 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 12 (39%) have results posted.
10 of the studies in Precursor Cell Lymphoblastic Leukemia-Lymphoma by City of Hope Medical Center that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06059391City of Hope Medical CenterCMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant | 2027-01-01 |
| NCT05364762City of Hope Medical CenterAdding Itacitinib to Cyclophosphamide and Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Hematopoietic Stem Cell Transplants | 2027-03-25 |
| NCT02094794City of Hope Medical CenterTotal Marrow and Lymphoid Irradiation and Chemotherapy Before DSCT in Treating Patients With High-Risk ALL or AML | 2027-05-04 |
| NCT04262843City of Hope Medical CenterTotal Marrow and Lymphoid Irradiation as Conditioning Regimen Before Hematopoietic Cell Transplantation in Patients With Myelodysplastic Syndrome or Acute Leukemia | 2027-05-11 |
| NCT04537871City of Hope Medical CenterCardiovascular Reserve Evaluation in Survivors of Transplant, CREST Study | 2027-05-25 |
Add all 10 to your calendar (.ics) → With an account.
Among the 55 studies in Precursor Cell Lymphoblastic Leukemia-Lymphoma by City of Hope Medical Center, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This phase I trial studies the side effects and best dose of asciminib when given together with intrathecal (IT) chemotherapy, dexamethasone, vincristine, and blinatumomab (asciminib-based induction therapy) in treating patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). Asciminib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as methotrexate 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. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving asciminib-based induction therapy may be safe, tolerable, and/or effective in treating patients with newly diagnosed Ph+ ALL.
PRIMARY OBJECTIVES:
I. Evaluate the safety of asciminib as the tyrosine kinase inhibitor (TKI) backbone in a chemotherapy minimizing induction strategy (dexamethasone, vincristine, IT chemotherapy, blinatumomab).
II. Determine the recommended phase 2 dose (RP2D) of asciminib induction therapy as the TKI backbone in a reduced intensity strategy for the treatment of Ph+ ALL.
SECONDARY OBJECTIVES:
I. To evaluate the safety and tolerability of an asciminib-based therapy for post-dose limiting toxicity (DLT) cycles.
II. To evaluate the complete molecular response (CMR) rate after 1 and 3 cycles.
III. To evaluate the complete response (CR)/CR with incomplete hematologic recovery (CRi) rate after 1 and 3 cycles.
IV. To evaluate 1-year overall survival and event-free survival rates. V. To evaluate the rate of transplant in patients achieving CR in cycle 1 (CR1).
VI. To evaluate the pharmacokinetics of asciminib in this combination. VII. To evaluate minimal residual disease negativity (MRD-) by clonoSEQ assay (clonoSEQ) after first and third cycles of induction.
EXPLORATORY OBJECTIVE:
I. Evaluate novel molecular minimal residual disease (MRD) status in plasma and cerebrospinal fluid (CSF).
OUTLINE: This is a dose-escalation study of asciminib in combination with triple IT chemotherapy, dexamethasone, vincristine, and blinatumomab.
Patients receive asciminib orally (PO) once daily (QD) or twice daily (BID) on days 1-28 of cycles 1 and 2 and days 1-42 of cycle 3, triple IT chemotherapy (methotrexate, cytarabine, corticosteroid) on days 1 and 14 of cycles 1 and 2 and days 1, 14, 28, and 42 of cycle 3, dexamethasone PO on days 1-4 and 11-14 of cycle 1, vincristine intravenously (IV) on days 1 and 14 of cycle 1, and blinatumomab IV on days 1-28 of cycle 2 and days 15-42 of cycle 3. Cycles repeat every 28 days (cycles 1 and 2) or 42 days (cycle 3) for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo echocardiography (ECHO) during screening, blood and CSF sample collection on study, and bone marrow aspiration throughout the study.
After completion of study treatment, patients are followed up at 30 days and then every 3 months for up to 1 year post-treatment start.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
(LVEF) ≥ 50%
Seronegative for antigen (Ag)/antibody (Ab) combo, virus (HCV), active virus (HBV) (surface antigen negative)
Meets other institutional and federal requirements for infectious disease titer requirements
Women of (WOCBP): negative urine or serum pregnancy test
Agreement by females and males of childbearing potential to use a highly effective method of or abstain from heterosexual activity for the course of the study through at least 120 days after the last dose of protocol therapy
Exclusion Criteria:
Cardiac or cardiac repolarization abnormality, including any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive asciminib PO QD or BID on days 1-28 of cycles 1 and 2 and days 1-42 of cycle 3, triple IT chemotherapy on days 1 and 14 of cycles 1 and 2 and days 1, 14, 28, and 42 of cycle 3, dexamethasone PO on days 1-4 and 11-14 of cycle 1, vincristine IV on days 1 and 14 of cycle 1, and blinatumomab IV on days 1-28 of cycle 2 and days 15-42 of cycle 3. Cycles repeat every 28 days (cycles 1 and 2) or 42 days (cycle 3) for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO during screening, blood and CSF sample collection on study, and bone marrow aspiration throughout the study.
Drug: Asciminib · Procedure: Biospecimen Collection · Biological: Blinatumomab · Procedure: Bone Marrow Aspiration · Drug: Corticosteroid · Drug: Cytarabine · Drug: Dexamethasone · Procedure: Echocardiography Test · Drug: Methotrexate · Drug: Vincristine
Given PO
Also known as: ABL 001, ABL-001, ABL001
Undergo blood and CSF sample collection
Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Given IV
Also known as: AMG 103, AMG-103, AMG103, Anti-CD19 x Anti-CD3 Bispecific Monoclonal Antibody, Anti-CD19/Anti-CD3 Recombinant Bispecific Monoclonal Antibody MT103, Blincyto, MEDI 538, MEDI-538, MEDI538, MT 103, MT-103, MT103
Undergo bone marrow aspiration
Given IT
Given IT
Also known as: .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-Cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453
Given PO
Also known as: Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycadron, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decadron DP, Decalix, Decameth, Decasone R.p., Dectancyl, Dekacort, Deltafluorene, Deronil, Desamethasone, Desameton, Dexa-Mamallet, Dexa-Rhinosan, Dexa-Scheroson, Dexa-sine, Dexacortal, Dexacortin, Dexafarma, Dexafluorene, Dexalocal, Dexamecortin, Dexameth, Dexamethasone Intensol, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Dxevo, Fluorodelta, Fortecortin, Gammacorten, Hemady, Hexadecadrol, Hexadrol, LenaDex, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, TaperDex, Visumetazone, ZoDex
Undergo ECHO
Also known as: EC, Echocardiography
Given IT
Also known as: Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate, CL 14377, CL-14377, Emtexate, Emthexat, Emthexate, Farmitrexat, Fauldexato, Folex, Folex PFS, Jylamvo, Lantarel, Ledertrexate, Lumexon, Maxtrex, Medsatrexate, Metex, Methoblastin, Methotrexate LPF, Methotrexate Methylaminopterin, Methotrexatum, Metotrexato, Metrotex, Mexate, Mexate-AQ, MTX, Novatrex, Rheumatrex, Texate, Tremetex, Trexeron, Trixilem, WR-19039
Given IV
Also known as: LCR, Leurocristine, VCR, Vincrystine
Incidence of dose limiting toxicity (DLT)
Toxicity will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE), version (v) 6.0.
Time frame: Up to 2 cycles (Cycle length = 28 days)
Maximum tolerated dose/recommended phase 2 dose
Will be established using a phase 1 queue 3+3 design.
Time frame: Up to the 18.6 months
Incidence of adverse events (AEs)
The number and percent of patients with AEs will be tabulated by system organ class and preferred term using the Medical Dictionary for Regulatory Activities preferred term dictionary. Observed toxicities will be summarized for the DLT period (cycles 1 and 2), as well as for each of the 3 cycles, in terms of type (organ affected or laboratory determination), severity, time of onset, duration, frequency, probable association with each study treatment and reversibility or outcome. Listings and narratives will be provided for deaths on study, DLTs/unacceptable toxicities, serious adverse events, and events leading to discontinuation of treatment. Descriptive summaries will also be generated for AE data assessed and graded according to the CTCAE v6.0 grading system.
Time frame: Up to 30 days after last dose of study drug
Complete molecular response
Will be assessed in accordance with the 2025 National Comprehensive Cancer Network (NCCN) guidelines at each dose level and disease assessment timepoint (cycles 1 and 3). Rates and 95% Clopper-Pearson binomial confidence interval (CI) will be calculated.
Time frame: At the completion of cycle 1 (Cycle length = 28 days) and cycle 3 (Cycle length = 42 days)
Complete response (CR)/CR with incomplete hematologic recovery
Will be assessed in accordance with the 2025 NCCN guidelines at each dose level and disease assessment timepoint (cycles 1 and 3). Rates and 95% Clopper-Pearson binomial CI will be calculated.
Time frame: At the completion of cycle 1 (Cycle length = 28 days) and cycle 3 (Cycle length = 42 days)
Minimal residual disease negativity
Will be assessed in accordance with the 2025 NCCN guidelines at each dose level and disease assessment timepoint (cycles 1 and 3). Rates and 95% Clopper-Pearson binomial CI will be calculated.
Time frame: At the completion of cycle 1 (Cycle length = 28 days) and cycle 3 (Cycle length = 42 days)
Rate of allogeneic hematopoietic cell transplantation
Rates and 95% Clopper-Pearson binomial CI will be calculated.
Time frame: Up to 1 cycle (Cycle length = 28 days)
Overall survival (OS)
Median OS and 1-year OS rate, will be estimated using the product-limit method of Kaplan-Meier product-limit method and the 95% C.I. of the survival curve will be calculated by the Brookmeyer-Crowley method with log-log transformation.
Time frame: From first study dose to death from any cause or last contact date, whichever comes first, assessed up to 1 year
Progression-free survival (PFS)
Median PFS and 1-year PFS rate, will be estimated using the product-limit method of Kaplan-Meier product-limit method and the 95% C.I. of the survival curve will be calculated by the Brookmeyer-Crowley method with log-log transformation.
Time frame: Up to 1 year
Concentration of asciminib (Pharmacokinetics)
Will be assessed over time by descriptive and graphical statistics.
Time frame: Up to 98 days (Cycle 1 and 2 are 28 days each, Cycle 3 is 42 days)
Start is estimated for Oct 2027; primary completion for Oct 2028, 12 months later.
Of 158 non-industry phase 1 interventional studies under Precursor Cell Lymphoblastic Leukemia-Lymphoma, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 92. This study's planned 12 months is below that.
Counting every sponsor, half of 208 studies reached it within 55 months; a quarter within 34 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Asciminib
Precursor Cell Lymphoblastic Leukemia-Lymphoma →