A Phase 2 interventional study of olverembatinib and Venetoclax in Ph+ Acute Lymphoblastic Leukemia (Ph+ALL), sponsored by Institute of Hematology & Blood Diseases Hospital, China. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Phase 2, Interventional, and Treatment
Among 11 studies testing olverembatinib in Precursor Cell Lymphoblastic Leukemia-Lymphoma — 10 open to participants now, 10 under way, 2 of them phase 3. olverembatinib · Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Among the 11 studies testing olverembatinib in Precursor Cell Lymphoblastic Leukemia-Lymphoma, this one is the 9th largest by planned enrollment, is the only one that started in 2026, is one of 5 in phase 2, and was the 11th registered.
2,584 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 473 are open to participants now.
This study's planned enrollment of 22 is below the median of 40 across 1,952 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →10 of the 11 studies testing olverembatinib in Precursor Cell Lymphoblastic Leukemia-Lymphoma are open now, in 12 countries. Each count lists the studies.
No approval found in the FDA or EMA files read. How studies give it is on its page →
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 →11 studies; the count open now beside each. This study's row is marked.
First in 2022; this study’s year is marked. 1 started in 2026.
Median enrollment 60 across the 11 interventional studies. Of the 1 that completed or were terminated, 0 (0%) have results posted.
1 of 11 have an industry lead sponsor. The 7 most frequent:
Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 410 studies on the registry; 291 are open to participants now.
28 studies in Precursor Cell Lymphoblastic Leukemia-Lymphoma by Institute of Hematology & Blood Diseases Hospital, China: 21 open now, 22 under way, 4 of them phase 3. Of 5 finished, 0 (0%) have results posted.
Among the 28 studies in Precursor Cell Lymphoblastic Leukemia-Lymphoma by Institute of Hematology & Blood Diseases Hospital, China, this one is the 19th largest by planned enrollment of the 26 interventional ones, is one of 7 that started in 2026, is one of 11 in phase 2, reaches primary completion later than 14 of the 21 other live ones, and was the 25th registered.
Institute of Hematology & Blood Diseases Hospital, China’s Precursor Cell Lymphoblastic Leukemia-Lymphoma studies by the year they started, since 2015.
2 of the studies testing olverembatinib in Precursor Cell Lymphoblastic Leukemia-Lymphoma that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06082934Xijing HospitalOlverembatinib Plus Venetoclax and Dexamethasone for Treatment-naïve Ph+ Acute Lymphoblastic Leukemia | 2026-11-01 |
| NCT05495035Institute of Hematology & Blood Diseases Hospital, ChinaStudy for Safety and Efficacy of Olverembatinib Combined With APG-2575 in Children With Relapsed/Refractory Ph + ALL | 2026-12-31 |
Among the 11 studies testing olverembatinib in Precursor Cell Lymphoblastic Leukemia-Lymphoma, from their registry updates:
Among Institute of Hematology & Blood Diseases Hospital, China’s 28 in Precursor Cell Lymphoblastic Leukemia-Lymphoma:
This is a prospective, open-label, single-arm, umbrella phase 2 clinical trial enrolling 22 adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) B-cell acute lymphoblastic leukemia (ALL).
As an umbrella trial, all patients share the same target disease (newly diagnosed Ph+ B-ALL) and receive a uniform induction backbone consisting of multi-targeted immunotherapy, targeted therapy, and reduced-intensity chemotherapy. After induction, patients are stratified and assigned to two distinct consolidation pathways based on clinical condition, performance status, resource availability, and patient preference:
Pathway A: Consolidation with CD19-directed CAR-T cell therapy to achieve deep molecular remission; Pathway B: Consolidation with sequential immunochemotherapy to maximize minimal residual disease (MRD) clearance.
A backup chemotherapy backbone is provided for patients ineligible for antibody therapy. All patients, regardless of consolidation pathway, proceed to a unified long-term maintenance regimen. The primary endpoint is the complete molecular remission (CMR) rate after one cycle of induction therapy. MRD is monitored longitudinally by flow cytometry, quantitative PCR, and immune repertoire sequencing. Safety is evaluated per NCI CTCAE version 5.0.
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.
Exclusion Criteria:
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.
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.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
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 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.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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 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.
All patients receive a uniform induction therapy backbone combining targeted therapy, immunotherapy, and reduced-intensity chemotherapy. After induction, patients are stratified into two consolidation pathways based on clinical status: 1) CD19 CAR-T cell therapy; 2) sequential immunochemotherapy. All patients proceed to a unified long-term maintenance regimen.
Drug: olverembatinib · Drug: Venetoclax · Drug: Inotuzumab Ozogamicin (IO) · Drug: Blinatumomab · Biological: CD19-directed chimeric antigen receptor (CAR-T) T cells
Third-generation tyrosine kinase inhibitor (TKI) targeting BCR::ABL1, administered orally daily as part of induction, consolidation, and maintenance therapy.
BCL-2 inhibitor administered orally daily during induction and consolidation cycles to enhance leukemic cell apoptosis.
Anti-CD22 antibody-drug conjugate (ADC) administered intravenously during induction and consolidation therapy.
CD19/CD3 bispecific T-cell engager (BiTE) administered as continuous intravenous infusion during consolidation therapy.
Autologous CD19 CAR-T cell therapy administered as a single intravenous infusion as optional consolidation therapy for eligible patients.
Complete Molecular Remission (CMR) Rate After 1 Cycle of Induction Therapy
The proportion of patients achieving complete molecular remission (CMR), defined as undetectable BCR::ABL1 transcript by quantitative PCR (BCR::ABL1/ABL1 ratio \< 0.001%), after 1 cycle of induction therapy.
Time frame: At the end of Cycle 1 (each cycle is 28 days, approximately 4 weeks from enrollment)
3-Month Complete Remission (CR)
Time frame: 3 months after study enrollment
3-Month MRD Negativity Rates
Time frame: 3 months after study enrollment
2-Year Overall Survival (OS)
OS is defined as the time from study enrollment to death from any cause.
Time frame: 2 years after the last patient enrollment
2-Year Disease-Free Survival (DFS)
DFS is defined as the time from study enrollment to disease relapse or death from any cause.
Time frame: 2 years after the last patient enrollment
2-Year Event-Free Survival (EFS)
EFS is defined as the time from study enrollment to first occurrence of predefined adverse events, disease progression or death.
Time frame: 2 years after the last patient enrollment
Incidence of Treatment-Related Adverse Events (TRAEs)
Number and severity of adverse events graded according to NCI CTCAE version 5.0.
Time frame: From study enrollment to 60 days after the last treatment
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for May 2028, 19 months later.
Of 208 non-industry phase 2 interventional studies under Precursor Cell Lymphoblastic Leukemia-Lymphoma, half reached primary completion within 79 months of starting (the median), counting those still running; a quarter within 43 and three quarters within 120. This study's planned 19 months is below that.
Counting every sponsor, half of 226 studies reached it within 74 months; a quarter within 42 and three quarters within 120.
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 Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Olverembatinib
Precursor Cell Lymphoblastic Leukemia-Lymphoma →
Institute of Hematology & Blood Diseases Hospital, China →