Leukemia

Verified discoveries, trials, and approvals for this cancer type. Every story separates evidence strength, regulatory status, and guideline position.

Latest Discoveries

Trial Watch: A Study of Acalabrutinib vs Investigator’s Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL

Research type: Registered later-phase trialRegulatory status: Investigational
Cancer type
Leukemia
Published
October 23, 2026

ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Active Not Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.

Primary source cited

Last reviewed

Trial Watch: Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia

Research type: Registered later-phase trialRegulatory status: Investigational
Cancer type
Leukemia
Published
October 23, 2026

ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Active Not Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.

Primary source cited

Last reviewed

Trial Watch: Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma

Research type: Registered later-phase trialRegulatory status: Investigational
Cancer type
Leukemia, Lymphoma
Published
October 22, 2026

ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Active Not Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.

Primary source cited

Last reviewed

Trial Watch: CINC424A2X01B Rollover Protocol

Research type: Registered later-phase trialRegulatory status: Investigational
Cancer type
Leukemia
Published
October 20, 2026

ClinicalTrials.gov confirms that this Phase 4 study is registered and currently listed as Active Not Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.

Primary source cited

Last reviewed

Trial Watch: Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia

Research type: Registered later-phase trialRegulatory status: Investigational
Cancer type
Leukemia
Published
October 19, 2026

ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.

Primary source cited

Last reviewed

Trial Watch: Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study

Research type: Registered later-phase trialRegulatory status: Investigational
Cancer type
Leukemia, Lymphoma
Published
September 17, 2026

ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.

Primary source cited

Last reviewed

Trial Watch: A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Lymphoblastic Leukaemia

Research type: Registered later-phase trialRegulatory status: Investigational
Cancer type
Leukemia
Published
September 16, 2026

ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Not Yet Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.

Primary source cited

Last reviewed

Major Advances

FDA approves blinatumomab in the consolidation phase of B-cell precursor acute lymphoblastic leukemia, regardless of MRD status

Research type: High-Certainty EvidenceRegulatory status: FDA Approved
Cancer type
Leukemia
Published
August 13, 2026

In the randomized, phase 3 ECOG-ACRIN E1910 trial, adding blinatumomab to consolidation chemotherapy significantly extended overall survival compared with chemotherapy alone in adults with MRD-negative B-cell precursor ALL — the…

Primary source cited

Last reviewed

FDA approves the first all-oral combination regimen for older adults with newly diagnosed acute myeloid leukemia

Research type: Emerging ClinicalRegulatory status: FDA Approved
Cancer type
Leukemia
Published
August 13, 2026

In the single-arm Study ASTX727-07, an all-oral combination of decitabine/cedazuridine (Inqovi) plus venetoclax produced a complete remission rate of 41.6% (and a combined complete-remission-or-partial-hematologic-recovery rate of 52.5%) in older or…

Primary source cited

Last reviewed

FDA grants traditional approval to pirtobrutinib for BTK-inhibitor-pretreated CLL/SLL

Research type: Later-stage studies in peopleRegulatory status: FDA Approved
Cancer type
Leukemia
Published
August 13, 2026

In the randomized, phase 3 BRUIN-CLL-321 trial, pirtobrutinib -- the first and only non-covalent (reversible) BTK inhibitor -- significantly extended progression-free survival compared with standard chemoimmunotherapy options in patients with…

Primary source cited

Last reviewed

Clinical Trials

Important: Eligibility and enrollment are not guaranteed, and listing here is not a treatment recommendation. Talk to your care team.

Trial Watch: A Study of Acalabrutinib vs Investigator’s Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL

Regulatory status: InvestigationalResearch type: Registered later-phase trial
Cancer type
Leukemia
Trial identifier
NCT02970318
Trial phase
Phase 3
View trial details
Study design
Not specified in this summary
Population
Participants age 18 Years and older with Chronic Lymphocytic Leukemia who meet the study-specific registry eligibility criteria.
Last reviewed
2026-10-23

Regulatory status by jurisdiction

Country or region not specified

Status
Investigational
Last verified
2026-10-23

Cancer-type scope for this record is not yet recorded.

Primary evidence supporting this story

Eligibility varies — review trial criteria.

Trial Watch: Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia

Regulatory status: InvestigationalResearch type: Registered later-phase trial
Cancer type
Leukemia
Trial identifier
NCT01886872
Trial phase
Phase 3
View trial details
Study design
Not specified in this summary
Population
Participants age 65 Years and older with Stage I Chronic Lymphocytic Leukemia, Stage II Chronic Lymphocytic Leukemia, Stage III Chronic Lymphocytic Leukemia, Stage IV Chronic Lymphocytic Leukemia who meet the study-specific registry eligibility criteria.
Last reviewed
2026-10-23

Regulatory status by jurisdiction

Country or region not specified

Status
Investigational
Last verified
2026-10-23

Cancer-type scope for this record is not yet recorded.

Primary evidence supporting this story

Eligibility varies — review trial criteria.

Trial Watch: Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma

Regulatory status: InvestigationalResearch type: Registered later-phase trial
Cancer type
Leukemia, Lymphoma
Trial identifier
NCT02112916
Trial phase
Phase 3
View trial details
Study design
Not specified in this summary
Population
Participants ages 1 Year to 30 Years with Adult T Acute Lymphoblastic Leukemia, Ann Arbor Stage II Adult Lymphoblastic Lymphoma, Ann Arbor Stage II Childhood Lymphoblastic Lymphoma, Ann Arbor Stage III Adult Lymphoblastic Lymphoma who meet the study-specific registry eligibility criteria.
Last reviewed
2026-10-22

Regulatory status by jurisdiction

Country or region not specified

Status
Investigational
Last verified
2026-10-22

Cancer-type scope for this record is not yet recorded.

Primary evidence supporting this story

Eligibility varies — review trial criteria.

Trial Watch: Framework for Optimizing, Refining, and Unifying Management of HSCT in Pediatric ALL

Regulatory status: InvestigationalResearch type: Registered later-phase trial
Cancer type
Leukemia
Trial identifier
NCT07297914
Trial phase
Phase 3
View trial details
Study design
Not specified in this summary
Population
Participants ages 3 Months to 25 Years with Acute Lymphoblastic Leukemia (ALL), Stem Cell Transplant, Graft -Versus-host-disease who meet the study-specific registry eligibility criteria.
Last reviewed
2026-10-21

Regulatory status by jurisdiction

Country or region not specified

Status
Investigational
Last verified
2026-10-21

Cancer-type scope for this record is not yet recorded.

Primary evidence supporting this story

Eligibility varies — review trial criteria.

Trial Watch: CINC424A2X01B Rollover Protocol

Regulatory status: InvestigationalResearch type: Registered later-phase trial
Cancer type
Leukemia
Trial identifier
NCT02386800
Trial phase
Phase 4
View trial details
Study design
Not specified in this summary
Population
Participants ages 1 Month to 100 Years with Primary Myelofibrosis, Polycythemia Vera, Graft Versus Host Disease, Acute Myeloid Leukemia who meet the study-specific registry eligibility criteria.
Last reviewed
2026-10-20

Regulatory status by jurisdiction

Country or region not specified

Status
Investigational
Last verified
2026-10-20

Cancer-type scope for this record is not yet recorded.

Primary evidence supporting this story

Eligibility varies — review trial criteria.

Trial Watch: Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia

Regulatory status: InvestigationalResearch type: Registered later-phase trial
Cancer type
Leukemia
Trial identifier
NCT03150693
Trial phase
Phase 3
View trial details
Study design
Not specified in this summary
Population
Participants ages 18 Years to 39 Years with B Acute Lymphoblastic Leukemia who meet the study-specific registry eligibility criteria.
Last reviewed
2026-10-19

Regulatory status by jurisdiction

Country or region not specified

Status
Investigational
Last verified
2026-10-19

Cancer-type scope for this record is not yet recorded.

Primary evidence supporting this story

Eligibility varies — review trial criteria.

FDA Approvals

Regulatory approval is separate from evidence certainty and from guideline position. Approval applies only to the exact indication stated in each jurisdiction record.

FDA approves blinatumomab in the consolidation phase of B-cell precursor acute lymphoblastic leukemia, regardless of MRD status

Regulatory status: FDA ApprovedResearch type: High-Certainty Evidence
Cancer type
Leukemia
Population
Adults 30 to 70 years old with CD19-positive, Philadelphia-chromosome-negative B-cell precursor acute lymphoblastic leukemia (BCP-ALL) in measurable-residual-disease-negative (MRD-negative) remission after induction and intensification chemotherapy, randomized to consolidation chemotherapy with or without blinatumomab. The FDA's broader approval also covers pediatric patients (1 month and older) and is not restricted to MRD-negative disease, supported by two additional pediatric relapse trials this record does not independently detail.
View approval details
Last reviewed
2026-08-13

Regulatory status by jurisdiction

United States (FDA)

Status
FDA-approved for the exact stated cancer/use
Indication
Adults and pediatric patients 1 month and older with CD19-positive, Philadelphia-chromosome-negative B-cell precursor acute lymphoblastic leukemia, in the consolidation phase of multiphase chemotherapy, regardless of measurable residual disease status.
Biomarker requirement
CD19-positive, Philadelphia chromosome-negative
Decision date
2024-06-14

Guideline positions

Guideline

Position
Not addressed
Last verified
2026-08-13

Primary evidence supporting this story

Applies to the exact indication stated.

FDA approves the first all-oral combination regimen for older adults with newly diagnosed acute myeloid leukemia

Regulatory status: FDA ApprovedResearch type: Emerging Clinical
Cancer type
Leukemia
Population
Adults 75 years or older, or with comorbidities precluding intensive induction chemotherapy, with newly diagnosed acute myeloid leukemia (AML), enrolled in the single-arm, open-label Study ASTX727-07.
View approval details
Last reviewed
2026-08-13

Regulatory status by jurisdiction

United States (FDA)

Status
FDA-approved for the exact stated cancer/use
Indication
Adults with newly diagnosed AML who are 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.
Decision date
2026-05-13

Guideline positions

Guideline

Position
Not addressed
Last verified
2026-08-13

Primary evidence supporting this story

Applies to the exact indication stated.

FDA grants traditional approval to pirtobrutinib for BTK-inhibitor-pretreated CLL/SLL

Regulatory status: FDA ApprovedResearch type: Later-stage studies in people
Cancer type
Leukemia
Population
Adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) previously treated with a covalent BTK inhibitor, randomized to pirtobrutinib or investigator's choice of idelalisib plus rituximab or bendamustine plus rituximab, in the randomized, open-label, phase 3 BRUIN-CLL-321 trial.
View approval details
Last reviewed
2026-08-13

Regulatory status by jurisdiction

United States (FDA)

Status
FDA-approved for the exact stated cancer/use
Indication
Adults with relapsed or refractory CLL/SLL who have previously been treated with a covalent BTK inhibitor.
Decision date
2025-12-03

Guideline positions

Guideline

Position
Not addressed
Last verified
2026-08-13

Primary evidence supporting this story

Applies to the exact indication stated.

Treatment Innovations

FDA approves the first all-oral combination regimen for older adults with newly diagnosed acute myeloid leukemia

Research type: Emerging ClinicalRegulatory status: FDA Approved
Cancer type
Leukemia
Published
August 13, 2026

In the single-arm Study ASTX727-07, an all-oral combination of decitabine/cedazuridine (Inqovi) plus venetoclax produced a complete remission rate of 41.6% (and a combined complete-remission-or-partial-hematologic-recovery rate of 52.5%) in older or…

Primary source cited

Last reviewed

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Related resources

Trusted resources: official cancer information

CancerDiscoveries summarizes verified records in its database. Absence of a listing here does not establish that a treatment lacks regulatory authorization or access.