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Home › Conditions › Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia

Part of Leukemia

17 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for Acute Lymphoblastic Leukemia

103 trials tracked for Acute Lymphoblastic Leukemia: 22 in phase 3 or 4 and 16 with published results. The most-cited published study has 325 citations.

103Trials tracked
22Phase 3 & 4
0Recruiting
16With published results
Phase distribution
Phase 4 4 Phase 3 18 Phase 2 62 Phase 1 10 Other / NA 9
  1. Phase 3 Phase 3 Trial of Blinatumomab vs Standard Chemotherapy in Pediatric Subjects With HIgh-Risk (HR) First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) Completed · 325 cited
  2. Phase 3 Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia Completed · 251 cited
  3. Phase 3 Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia Completed · 231 cited
  4. Phase 3 Graft-Versus-Host Disease Prophylaxis in Treating Patients With Hematologic Malignancies Undergoing Unrelated Donor Peripheral Blood Stem Cell Transplant Completed · 112 cited
  5. Phase 3 Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma Completed · 102 cited
  6. Phase 3 Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia Completed · 89 cited
Show 44 more trials
  1. Phase 3 A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia Completed · 76 cited
  2. Phase 3 A Study of the Safety and Effectiveness of Apixaban in Preventing Blood Clots in Children With Leukemia Who Have a Central Venous Catheter and Are Treated With Asparaginase Completed · 50 cited
  3. Phase 3 Phase III B in Acute Lymphoblastic Leukemia Completed · 49 cited
  4. Phase 3 Calaspargase Pegol or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia Completed · 47 cited
  5. Phase 3 Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia Completed · 37 cited
  6. Phase 3 An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL) Completed · 31 cited
  7. Phase 4 Vaccinating Children After Chemotherapy Completed · 25 cited
  8. Phase 4 A Study Of Two Inotuzumab Ozogamicin Doses in Relapsed/ Refractory Acute Lymphoblastic Leukemia Transplant Eligible Patients Completed · 17 cited
  9. Phase 3 Tac, Mini-MTX, MMF Versus Tac, MTX for GVHD Prevention Completed · 11 cited
  10. Phase 3 Efficacy and Safety of the BiTE Antibody Blinatumomab in Chinese Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) Completed · 9 cited
  11. Phase 4 A Study of Inotuzumab Ozogamicin in Chinese Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia Completed
  12. Phase 4 Learning Impairments Among Survivors of Childhood Cancer Completed
  13. Phase 3 Therapy for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia Completed
  14. Phase 3 Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia Completed
  15. Phase 3 Methotrexate or Pentostatin for Graft-versus-host Disease Prophylaxis in Risk-adapted Allogeneic Bone Marrow Transplantation for Hematologic Malignancies Completed
  16. Phase 3 A Severity-Adapted Clinical Trial of Diminished Bone Mineral Density in Acute Lymphoblastic Leukemia Survivors Completed
  17. Phase 2 T Cell Depletion for Recipients of HLA Haploidentical Related Donor Stem Cell Grafts Completed
  18. Phase 2 Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia Completed
  19. Phase 2 Safety and Efficacy of BL-8040 for the Mobilization of Donor Hematopoietic Stem Cells and Allogeneic Transplantation in Patients With Advanced Hematological Malignancies Completed
  20. Phase 2 Reduced Intensity Flu/Mel/TBI Conditioning for HAPLO HCT Patients With Hematologic Malignancies Completed
  21. Phase 2 Combination Chemotherapy and Dasatinib in Treating Participants With Philadelphia Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia. Completed
  22. Phase 2 Clofarabine-cyclophosphamide as Salvage Therapy for Refractory and Relapsed Acute Lymphoblastic Leukemia (ALL) Adults Completed
  23. Phase 2 Tocilizumab for the Prevention of Graft Versus Host Disease After Cord Blood Transplantation Completed
  24. Phase 2 Treatment of Adult Ph+ LAL With BMS-354825 Completed
  25. Phase 2 Study Evaluating AMD3100 for Transplantation of Sibling Donor Stem Cells in Patients With Hematological Malignancies Completed
  26. Phase 2 Safety and Efficacy of Donor T-lymphocytes Depleted ex Vivo of Host Alloreactive T-cells (ATIR) in Patients With a Hematologic Malignancy Who Received a Hematopoietic Stem Cell Transplantation From a Haploidentical Donor Completed
  27. Phase 2 Pilot of Abatacept-based Immunosuppression for Prevention of Acute GvHD During Unrelated Donor HCT Completed
  28. Phase 2 ALL Adult Consortium Trial: Adult ALL Trial Completed
  29. Phase 2 Treatment of Older Adults With Acute Lymphoblastic Leukemia Completed
  30. Phase 2 Vyxeos(CPX-351) in Adults w R/R Acute Lymphoblastic Leukemia Completed
  31. Phase 2 Busulfan/Clofarabine + Allogeneic Stem Cell Transplantation Completed
  32. Phase 2 Sirolimus, Cyclosporine, and Mycophenolate Mofetil in Preventing Graft-versus-Host Disease in Treating Patients With Blood Cancer Undergoing Donor Peripheral Blood Stem Cell Transplant Completed
  33. Phase 2 Therapy for Pediatric Relapsed or Refractory Acute Lymphoblastic Leukemia Completed
  34. Phase 2 Methods to Enhance the Safety and Effectiveness of Stem Cell Transplants Completed
  35. Phase 2 A Roll-over Study to Provide Continued Treatment With Lyophilized Pegaspargase (S95014) in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL) Completed
  36. Phase 2 Sitagliptin Umbilical Cord Blood Transplant Study Completed
  37. Phase 2 Study of Augmented Hyper-CVAD in Acute Lymphoblastic Leukemia Salvage Completed
  38. Phase 2 Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase) in Elderly Patients With First Line Acute Lymphoblastic Leukemia Completed
  39. Phase 2 Combination Chemotherapy and Ofatumumab in Treating Patients With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma Completed
  40. Phase 2 Ibrutinib in Preventing Acute Leukemia in Patients After Reduced-Intensity Conditioning and Stem Cell Transplant Completed
  41. Phase 2 Nebulized Amphotericin B Lipid Complex in Invasive Pulmonary Aspergillosis in Paediatric Patients With Acute Leukaemia Completed
  42. Phase 2 A Study in Adults With Untreated Acute Lymphoblastic Leukemia Completed
  43. Phase 2 Clofarabine and Cyclophosphamide Combination in Acute Lymphoblastic Leukemia Patients Completed
  44. Phase 2 CMC-544 in Relapsed Refractory Acute Lymphoblastic Leukemia (ALL) Completed

Showing the 50 most-cited and recently-updated of 103 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found Updated — new results For clinicians

Acute Lymphoblastic Leukemia: what the trials found

Several targeted and chimeric antigen receptor (CAR) therapies have demonstrated efficacy in patients with Acute Lymphoblastic Leukemia. Blinatumomab showed significant improvements in event-free survival (EFS) 7 and high rates of hematological response, including CR/CRh* or CRi, during the first two treatment cycles 20. Inotuzumab ozogamicin demonstrated a significantly higher percentage of patients achieving hematologic remission compared to standard treatments 13, with 81.8% to 47.7% reaching CR or CRi depending on the cohort 5. Additionally, Calaspargase Pegol-mknl was associated with high rates of complete remission at the end of induction (92.4% to 97.6%) and favorable event-free survival 16.

Asparaginase remains a cornerstone of treatment; studies show that its use, particularly in combination with other agents like Dasatinib, significantly impacts minimal residual disease (MRD) status at the end of induction 8. High-dose versus conventional dose PEG-asparaginase showed comparable rates of continuous complete remission 12. Additionally, while some trials investigated the impact of Lestaurtinib on MLL-R infants treated with combination chemotherapy and Asparaginase, no significant difference in event-free survival was observed between treatment arms 17.

Clinical assessments of supportive care and complications indicate that Cyclophosphamide is a standard component of therapy [9, 21]. Research into the impact of various agents on complications shows that tacrolimus may reduce the incidence of severe mucositis and acute GVHD compared to other regimens 19, while certain interventions like inotuzumab ozogamicin were associated with low rates of significant laboratory test shifts 4.

Research regarding the physiological impacts of the disease has identified significant differences in brain white matter volume between patients with Acute Lymphoblastic Leukemia and sibling controls, as well as between those with ALL and those with other types of brain tumors 6.

Recent results — preliminary, needs further review

  • Siltuximab was evaluated in a Phase 2 trial (N=24) for the treatment of this condition 1.
  • Cyclosporine was evaluated in a Phase 2 study where the median time to onset of Grade II-IV aGVHD by Day 100 was 34 days 2.

For the clinician treating this condition

  • Blinatumomab and Inotuzumab ozogamicin are established options for achieving high rates of hematologic response and improved event-free survival.
  • Asparaginase remains a core component of treatment, with significant implications for minimal residual disease (MRD) status.
  • Calaspargase Pegol-mknl is associated with high induction remission rates and favorable event-free survival.

AI synthesis of 13 cited trials, updated Jun 26, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
Asparaginase therapy in acute lymphoblastic leukemia patients correlates with increased thromboembolism risk in specific subgroups
Oncology Meta-analysis
Asparaginase therapy in acute lymphoblastic leukemia patients correlates with increased thromboembolism risk in specific subgroups Adults with Leukemia Show Higher Risk of Blood Clots
This meta-analysis examined the incidence of thromboembolism among patients with acute lymphoblastic leukemia receiving asparaginase based c…
Patients with acute lymphoblastic leukemia treated with asparaginase face higher risks of blood clots, especially adults and those with spec…
Jun 26, 2026
Xatmep receives FDA approval for pediatric acute lymphoblastic leukemia and polyarticular juvenile idiopathic arthritis
Hematology FDA Approval
Xatmep receives FDA approval for pediatric acute lymphoblastic leukemia and polyarticular juvenile idiopathic arthritis FDA approves Xatmep for pediatric leukemia and arthritis treatment options
The FDA has approved Xatmep for pediatric patients with acute lymphoblastic leukemia or active polyarticular juvenile idiopathic arthritis. …
The FDA has approved Xatmep to treat specific forms of childhood leukemia and arthritis, offering new options for young patients.
FDA May 30, 2026
Meta-analysis finds fluoroquinolone prophylaxis reduces febrile neutropenia in pediatric ALL
Oncology Meta-analysis
Meta-analysis finds fluoroquinolone prophylaxis reduces febrile neutropenia in pediatric ALL Fluoroquinolone antibiotics lower febrile neutropenia risk in children with acute lymphoblastic leukemia during treatment start
This systematic review and meta-analysis of 991 children with acute lymphoblastic leukemia found that fluoroquinolone prophylaxis reduced fe…
A review of children with acute lymphoblastic leukemia shows fluoroquinolone antibiotics reduce febrile neutropenia risk. This finding sugge…
May 1, 2026
Lyophilized pegaspargase shows similar activity to liquid form in pediatric ALL
Oncology RCT
Lyophilized pegaspargase shows similar activity to liquid form in pediatric ALL Lyophilized pegaspargase shows similar activity and safety to liquid form for pediatric leukemia patients
This phase 2 study in 89 pediatric ALL patients in Russia found that lyophilized pegaspargase had similar maximum plasma asparaginase activi…
A new form of pegaspargase works just like the liquid version for treating acute lymphoblastic leukemia in children in Russia.
May 1, 2026
Meta-analysis links perinatal factors to childhood acute leukemia risk
Hematology Meta-analysis
Meta-analysis links perinatal factors to childhood acute leukemia risk Perinatal factors linked to higher leukemia risk in children
This systematic review and meta-analysis of 85 studies examined perinatal factors and childhood acute leukemia risk.
A large analysis of 85 studies finds links between birth weight, maternal history, and cesarean sections with childhood leukemia risk.
May 1, 2026
Meta-analysis links maternal infection in pregnancy to childhood ALL risk
Hematology Meta-analysis
Meta-analysis links maternal infection in pregnancy to childhood ALL risk Maternal Infections During Pregnancy Linked to Higher Risk of Childhood Leukemia
This systematic review and meta-analysis of 26 studies found a modest association between maternal infection during pregnancy and childhood …
A large review of 26 studies found that maternal infections during pregnancy are associated with an increased risk of acute lymphoblastic le…
May 1, 2026
Review of observational data on non-sedated MRI feasibility in newly diagnosed ALL patients ages 3 to 10 years
Oncology
Review of observational data on non-sedated MRI feasibility in newly diagnosed ALL patients ages 3 to 10 years Non-sedated MRI scans work for young leukemia patients with practice
This review synthesizes observational data from a community setting involving 17 newly diagnosed ALL patients and 30 controls ages 3 to 10 y…
Young children with acute lymphoblastic leukemia can undergo non-sedated MRI scans. Success rates improve with repeated visits and behaviora…
medRxiv Apr 30, 2026
Review of observational data on vaccine antibody levels in children with acute lymphoblastic leukemia
Oncology
Review of observational data on vaccine antibody levels in children with acute lymphoblastic leukemia Do routine vaccines work normally for children fighting acute lymphoblastic leukemia?
This narrative review synthesizes observational data regarding routine childhood measles and varicella zoster virus vaccines in children wit…
Children with leukemia have lower antibody levels after measles and chickenpox vaccines, but their immune cells still function well, suggest…
medRxiv Apr 16, 2026
Registry-based systematic review maps non-pharmacological cancer trials in Africa
Oncology Meta-analysis
Registry-based systematic review maps non-pharmacological cancer trials in Africa Are lifestyle changes for cancer in Africa being studied enough, or do we need more local trials?
This registry-based systematic review analyzed 53 trials of lifestyle and non-pharmacological interventions for cancer patients in Africa.
Advice from wealthy nations may not work in Africa, where most cancer lifestyle trials happen in Egypt while Kenya and Nigeria are largely i…
Frontiers Apr 15, 2026
Pediatric ALL outcomes at Muhimbili National Hospital show 72% 12-month survival with no significant differences by demographic or care pathway factors
Pediatrics Cohort
Pediatric ALL outcomes at Muhimbili National Hospital show 72% 12-month survival with no significant differences by demographic or care pathway factors The Long Road to a Leukemia Diagnosis in Tanzania
This retrospective observational cohort study evaluated 64 pediatric patients with acute lymphoblastic leukemia admitted to Muhimbili Nation…
In Tanzania, children with leukemia wait nearly a month for specialist care, and most die during the first weeks of treatment.
Frontiers Apr 14, 2026
6-MP mini-tablets show bioequivalence to reference tablets in fasted children with ALL
Oncology RCT
6-MP mini-tablets show bioequivalence to reference tablets in fasted children with ALL A Tiny New Pill Could Transform Cancer Care for Children
Two open-label, randomized, crossover trials in children with acute lymphoblastic leukemia compared a novel 6-MP mini-tablet to a reference …
A tiny new pill for childhood leukemia works just as well as the standard version, but eating food before taking it dramatically reduces its…
Apr 10, 2026
Red blood cell parameters predict sepsis in children with ALL and chemotherapy-induced neutropenia
Pediatrics Cohort
Red blood cell parameters predict sepsis in children with ALL and chemotherapy-induced neutropenia A Simple Blood Test Could Warn of Sepsis in Children on Chemotherapy
This retrospective cohort study evaluated red blood cell parameters in children with acute lymphoblastic leukemia who developed chemotherapy…
Doctors may have found a faster, simpler way to spot a deadly infection in children undergoing cancer treatment.
Frontiers Apr 10, 2026

Research across Leukemia

Related studies from across the Leukemia family.

TKI plus chemotherapy achieves deep molecular remission in Ph+ leukemia case with diagnostic framework
Allergy & Immunology Meta-analysis
TKI plus chemotherapy achieves deep molecular remission in Ph+ leukemia case with diagnostic framework One patient's leukemia remission offers clues for rare diagnosis
This systematic review with a case report describes a patient with Philadelphia chromosome-positive leukemia who achieved complete remission…
A patient with a rare leukemia achieved deep remission for 35 months. The case highlights how to tell apart two similar-looking blood cancer…
Frontiers Jul 29, 2026
Imatinib achieves complete cytogenetic response in a pediatric patient with suspected chronic myeloid leukemia
Pediatrics Sys. Review
Imatinib achieves complete cytogenetic response in a pediatric patient with suspected chronic myeloid leukemia Imatinib works for CML in child with high platelets
This case report describes a pediatric patient with isolated thrombocytosis who achieved a complete cytogenetic response to imatinib after f…
A child with high platelets and no response to standard therapy was found to have CML and responded to imatinib.
Frontiers Jul 21, 2026
Venetoclax plus intensive chemo yields 63.79% ORR in relapsed/refractory AML meta-analysis
Hematology Meta-analysis
Venetoclax plus intensive chemo yields 63.79% ORR in relapsed/refractory AML meta-analysis Venetoclax combo shows promise for hard-to-treat leukemia
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GSTO1 inhibition induces apoptosis in AML cells while LMRS model stratifies patient risk
Allergy & Immunology Guideline
GSTO1 inhibition induces apoptosis in AML cells while LMRS model stratifies patient risk New lipid metabolism markers help predict outcomes for leukemia patients
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Researchers identified a new way to group and predict survival for patients with acute myeloid leukemia using lipid metabolism patterns.
Frontiers Jun 30, 2026
Low-dose ATG plus PTCy shows no significant difference in acute GVHD compared to standard regimens
Hematology RCT
Low-dose ATG plus PTCy shows no significant difference in acute GVHD compared to standard regimens Trial Shows New Treatment Strategy for Leukemia Stem Cell Transplant
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Blood Jun 25, 2026
Venetoclax-based combinations show superior progression-free survival compared to chemoimmunotherapy in CLL without TP53 aberrations
Oncology RCT
Venetoclax-based combinations show superior progression-free survival compared to chemoimmunotherapy in CLL without TP53 aberrations Trial shows venetoclax combinations improve progression-free survival in CLL
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AZA or LDAC combined with venetoclax likely improves mortality, remission, and quality of life
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AZA or LDAC combined with venetoclax likely improves mortality, remission, and quality of life New combinations show promise for older adults with myeloid leukemia
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7-day venetoclax with intensive chemotherapy achieves 90.3% composite complete remission in AML
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Rate of drug concentration rise alters hemodynamic responses and mortality risk in coronary heart disease patients
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Novel strategies aim to separate GVHD from GVL effects in allo-HCT for AML
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HMA-venetoclax yields 50% overall response rate in relapsed/refractory AML meta-analysis
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Antibody-based therapies offer potential efficacy and durability options for relapsed refractory acute myeloid leukemia patients
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Questions about Acute Lymphoblastic Leukemia

Do factors like age or where a child lives change survival chances for Acute Lymphoblastic Leukemia?

Yes, age and geographic location affect survival in pediatric ALL; younger children and those in high-income countries generally have better outcomes.

Full answer →
Does taking fluoroquinolone medicine help reduce high fevers in children with Acute Lymphoblastic Leukemia?

Fluoroquinolone prophylaxis reduces febrile neutropenia (fever with low white blood cells) in children with ALL, but it is not a treatment for high fevers; it is a preventive measure given during chemotherapy.

Full answer →

All Acute Lymphoblastic Leukemia Articles