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Clinical trials for leukaemia in Romania

Which trials are taking patients now, in which cities, and what to ask your doctor. The official record stays with the national agency.

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How to read this list

Each row is an authorised trial looking for participants. The plain-language title is written by our editorial team, and underneath it you can see the original registry title — so you can check for yourself that we did not change the meaning. We cannot tell you whether you are eligible, and we do not publish the hospital name: the international registry does not carry it, and a wrong name would send you to a room where nobody expects you. For the centre and the team's contact details, open the official record.

Trials recruiting now

18 of 19 titles have been rewritten in plain language by our editorial team. The rest still show the registry's protocol wording.

Trials testing a treatment · 17 studies

Something new is being tried here: a medicine, a regimen or a procedure. If you join, you receive either the treatment under study or the standard one, and the team follows you closely.

Preventing infections in patients with low immunoglobulins: subcutaneous immunoglobulin compared with placebo

The primary purpose of the study is to evaluate whether biweekly administered XEMBIFY® plus Standard Medical Treatment (SMT) over a one-year period will reduce the rate of major bacterial infections per participant per year in B-cell CLL, MM, and NHL participants with hypogammaglobulinemia (HGG) in comparison to the Placebo plus SMT group.

For: Hypogammaglobulinemia, Bacterial Infections, B-cell Chronic Lymphocytic Leukemia, Multiple Myleoma

6 centres: Brașov · București · Cluj-Napoca · and 3 more

Phase 3See the official record ↗NCT05645107

Original registry title

A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma

Relapsed chronic lymphocytic leukaemia or small lymphocytic lymphoma: pirtobrutinib

The main purpose of Part 1 of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have received 1-3 lines of treatment including a covalent Bruton tyrosine kinase (BTK) inhibitor. The purpose of Part 2 of this study is to evaluate pirtobrutinib monotherapy in participants with treatment-naïve CLL/SLL with 17p deletions. Participation in Part 1 is expected to last approximately 3 years. Participation in Part 2 is expected to last up to 2 years.

For: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

5 centres: Fundeni Clinical Institute, București · Institutul Oncologic Cluj, Cluj-Napoca · Spitalul Clinic Municipal Filantropia Craiova, Craiova · and 2 more

Phase 2See the official record ↗NCT06588478

Original registry title

A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Blood cancers: nemtabrutinib, a medicine under study

The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter's transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström's macroglobulinemia (WM).

For: Hematologic Malignancies, Waldenstroms Macroglobulinaemia, Non-Hodgkins Lymphoma, Chronic Lymphocytic Leukaemia

4 centres: Centrul de Diagnostic si Tratament Oncologic Brasov, Brașov · Spitalul Clinic Colțea, București · Institutul Regional de Oncologie Iasi, Iași · and 1 more

Phase 2See the official record ↗NCT04728893

Original registry title

Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)

Newly diagnosed Ph+ acute lymphoblastic leukaemia: olverembatinib

A global multicenter, open-label, randomized and registrational Phase 3 study to evaluate efficacy and safety of olverembatinib combined with chemotherapy versus investigator's choice of tyrosine kinase inhibitor (TKI) combined with chemotherapy in subjects with newly-diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL).

For: Ph+ ALL, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive

4 centres: București · Cluj-Napoca · Craiova · and 1 more

Phase 3See the official record ↗NCT06051409

Original registry title

A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)

Newly diagnosed acute myeloid leukaemia with an NPM1 mutation: revumenib added to intensive chemotherapy

The purpose of this study is to assess if adding revumenib to standard chemotherapy improves outcomes in participants with AML with certain genetic mutations compared to chemotherapy alone. The study will also assess the safety of adding revumenib to chemotherapy.

For: Acute Myeloid Leukemias

4 centres: București · Cluj-Napoca · Iași · and 1 more

Phase 3See the official record ↗NCT07211958

Original registry title

Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation

Chronic lymphocytic leukaemia or small lymphocytic lymphoma: APG2575, a medicine under study

This is a global multicenter, open label, randomized, registrational phase III study to investigate the efficacy and safety of lisaftoclax in combination with BTK inhibitors in CLL/SLL patients who previously treated with BTK inhibitors

For: CLL/SLL

3 centres: București · Cluj-Napoca · Timișoara

Phase 3See the official record ↗NCT06104566

Original registry title

Global Trial in APG2575 for Patients With CLL/SLL

Relapsed chronic lymphocytic leukaemia or small lymphocytic lymphoma: BGB-16673 compared with pirtobrutinib

The purpose of this study is to evaluate the efficacy and safety of tacabrutideg alone compared with pirtobrutinib in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi).

For: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

3 centres: Coltea Clinical Hospital, București · Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca, ClujNapoca · Institutul Regional de Oncologie Iasi, Iași

Phase 3See the official record ↗NCT06973187

Original registry title

A Study to Evaluate the Safety and Efficacy of Tacabrutideg (BGB-16673) Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Untreated chronic lymphocytic leukaemia: sonrotoclax with zanubrutinib compared with venetoclax with acalabrutinib

The purpose of this study is to investigate the efficacy and safety of fixed-duration sonrotoclax (also known as BGB-11417) plus zanubrutinib (also known as BGB-3111) (SZ) compared with fixed-duration of venetoclax plus acalabrutinib (AV) in participants with previously untreated chronic lymphocytic leukemia (CLL).

For: Chronic Lymphocytic Leukemia

3 centres: Coltea Clinical Hospital, București · Institutul Clinic Fundeni, Bucureti · Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca, ClujNapoca

Phase 3See the official record ↗NCT07277231

Original registry title

A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia

Acute lymphoblastic leukaemia in children and adolescents: stem cell transplant from a donor

The ALL SCTped 2012 FORUM is a multinational, multi-centre, controlled, prospective phase III study for the therapy and therapy optimisation for children and adolescents with ALL in complete morphological remission (CR, less than 5% bone marrow blasts, no blasts in cerebrospinal fluid, no other extramedullary leukemia), who have an indication for HSCT with a myeloablative conditioning regimen. The stratification of patients in first and following remissions according to the individual transplantation modalities rests upon an indication for allogeneic HSCT and the availability of a suitable donor within the individual transplantation groups.

For: Acute Lymphoblastic Leukaemia

2 centres: IInsitutul Clinic Fundeni, Sectia de Transplant Medular, București · University of Medicine and Pharmacy V. BABES, Emergency Children's Hospital LOUIS TURCANU, III. Clinic of Pediatrics , Department of Onco-hematology and Bone Marrow Transplantation, Timișoara

Phase 2See the official record ↗NCT01949129

Original registry title

Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia

Acute myeloid leukaemia or myelodysplastic syndrome with kidney impairment: how oral decitabine with cedazuridine behaves

This is a Phase 1b, multicenter, open-label, PK, and safety study of multiple oral doses of oral decitabine and cedazuridine (formerly known as ASTX727) as a fixed-dose combination of decitabine 35 milligrams (mg) and cedazuridine 100 mg in cancer participants with severe renal impairment and cancer participants with normal renal function as matched control participants. Adult participants with acute myeloid lymphoma (AML), myelodysplastic syndrome (MDS), or solid tumors who are candidates to receive oral decitabine and cedazuridine will be enrolled in this study. Study duration per participant is approximately up to 8 weeks.

For: Acute Myeloid Leukemia, Myelodysplastic Syndromes

2 centres: Institutul Oncologic Bucuresti - Prof. Dr. Alexandru Trestioreanu, București · Institutul Oncologic Prof. Dr. Ion Chiricuta, Cluj-Napoca

Phase 1See the official record ↗NCT04953897

Original registry title

Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal Impairment

Acute myeloid leukaemia or myelodysplastic syndrome with liver impairment: how oral decitabine with cedazuridine behaves

This is a Phase 1b, multicenter, open-label, pharmacokinetic (PK), and safety study of multiple oral doses of oral decitabine and cedazuridine (formerly known as ASTX727) as a fixed-dose combination of decitabine 35 milligrams (mg) and cedazuridine 100 mg in cancer participants with moderate and severe hepatic impairment and cancer participants with normal hepatic function as control participants. Participants with severe hepatic impairment will be enrolled only after the safety evaluation of at least 6 participants with moderate hepatic impairment has been determined and supports the enrollment of participants with severe hepatic impairment. Adult participants with acute myeloid lymphoma (AML), myelodysplastic syndrome (MDS), or solid tumors who are candidates to receive oral decitabine and cedazuridine will be enrolled in this study. Study duration is per participant approximately up to 8 weeks.

For: Acute Myeloid Leukemia, Myelodysplastic Syndromes

2 centres: Institutul Oncologic Bucuresti - Prof. Dr. Alexandru Trestioreanu, București · Institutul Oncologic Prof. Dr. Ion Chiricuta, Cluj-Napoca

Phase 1See the official record ↗NCT04953910

Original registry title

Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Hepatic Impairment

Acute myeloid leukaemia around a stem cell transplant: mocravimod as add-on and maintenance treatment

This is a multi-center, randomized, double-blinded, placebo controlled trial.

For: Adult Acute Myeloid Leukemia

2 centres: Institutul Clinic Fundeni, București · Institutul Regional de Oncologie Iasi, - Haematology Department, Iași

Phase 3See the official record ↗NCT05429632

Original registry title

Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT

Chronic myeloid leukaemia: continued asciminib for people who already received it in a study

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

For: Chronic Myelogenous Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive

One centre: Timișoara

Phase 4See the official record ↗NCT04877522

Original registry title

Asciminib Roll-over Study

Recurring chronic lymphocytic leukaemia: oral venetoclax alongside intravenous obinutuzumab

Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess retreatment with venetoclax-obinutuzumab (VenG) in participants previously treated with fixed duration first-line (IL) therapy of venetoclax in combination with an anti-CD20 antibody +/- X (where X is any additional drug). Adverse events and change in disease activity will be assessed. Venetoclax is an approved drug for the treatment of CLL. Study doctors put the participants in 1 of 2 groups, called cohorts, based on when symptoms of CLL came back after previous treatment in first-line. Approximately 75 adult participants with CLL who have been treated with venetoclax in combination with an anti-CD20 antibody +/- X will be enrolled in the study in approximately 60 sites worldwide. Participants will receive intravenous (IV) obinutuzumab + oral venetoclax (VenG) in 28-day cycles for a total of 6 cycles per cohort, followed by 6 to 18 cycles of venetoclax alone, for a total treatment of 12 to 24 cycles, depending on the cohort. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

For: Chronic Lymphocytic Leukemia (CLL)

One centre: Fundeni Clinical Institute, București

Phase 2See the official record ↗NCT04895436

Original registry title

Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)

Relapsed or refractory acute myeloid leukaemia: a trial comparing treatments used in everyday practice

This is a multicenter, randomized, open-label, pragmatic low intervention clinical trial comparing high intensity reinduction chemotherapy with low intensity therapies in 1st or 2nd relapse Acute Myeloid Leukemia. The study is funded by European Commission (HORIZON-MISS-2022-CANCER-01-03, Project ID 101104421)

For: Acute Myeloid Leukemia, Relapse/Recurrence

One centre: Fundeni Clinical Institute, București

Phase 3See the official record ↗NCT06713837

Original registry title

IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia.

Refractory or relapsed acute myeloid leukaemia: L-annamycin added to cytarabine as second-line therapy

This pivotal phase 2/3, multi-center, adaptive design study of L-Annamycin for Injection in combination with Cytarabine Injection as second line therapy for remission induction in adult subjects with refractory/relapsed AML is divided into two parts, Part A and Part B.

For: Acute Myeloid Leukaemia (AML)

One centre: ARENSIA research clinic at the Oncology Institute "Prof. Dr. Ion Chiricuţă", Cluj-Napoca

Phase 2See the official record ↗NCT06788756

Original registry title

L-Annamycin for Injection in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Relapsed AML

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.

For: 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

One centre: Quetzal Site 19, Cluj-Napoca

Phase 3See the official record ↗NCT07504458

Full title

Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia

Observational studies · 2 studies

You do NOT receive a new treatment here. You have your usual care, and researchers collect information about how it goes. Useful for people after you, but it does not change your own care.

Relapsed or refractory acute myeloid leukaemia: a master framework testing several treatments

This is an observational (non-interventional), prospective, cohort study that will collects data from patients diagnosed with relapsed or refractory acute myeloid leukemia afferent to the participanting clinical sites

For: Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory

One centre: Fundeni Clinical Institute, București

Phase not statedSee the official record ↗NCT06459024

Original registry title

Master Framework For Relapse or Refractory Acute Myeloid Leukemia

First-line chronic lymphocytic leukaemia: ibrutinib and venetoclax for a fixed duration, followed in routine practice

The purpose of this study is to see how well Ibrutinib and Venetoclax (I+V) treatment works (effectiveness) for participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) when it is used in routine, everyday medical care.

For: Leukemia, Lymphocytic, Chronic, B-Cell

One centre: Spitalul Universitar de Urgenta Bucuresti, București

Phase not statedSee the official record ↗NCT07602088

Original registry title

A Real-world Study of Ibrutinib and Venetoclax (I+V) First-Line Treatment Given for Fixed-duration of Time in Participants With Chronic Lymphocytic Leukemia

Source: ClinicalTrials.gov, the public registry of the US National Library of Medicine. Data retrieved on 14 Sept 2026.

Worth reading before you talk to your doctor

Material from our library to help you prepare your questions.

Where the official information lives

The road ends at the registry, not with us. That is where each trial's full record is — including the things we do not publish.

Where the data on this page comes from

The counts come from ClinicalTrials.gov and reflect trials marked in the registry as recruiting, with at least one site in Romania. A “recruiting” status does not guarantee that a site is still accepting patients on the day you check, because the registry may lag behind the situation at the hospital. For any decision, consult the official record and discuss it with your doctor.

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