Acute Lymphoblastic Leukemia

Oncology
29
Pipeline Programs
17
Companies
50
Clinical Trials
10 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
8
3
13
1
3
1
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Cell Therapy
444%
Small Molecule
222%
Monoclonal Antibody
222%
ADC
111%
+ 21 programs with unclassified modality

On Market (1)

Approved therapies currently available

Amgen
BLINCYTOApproved
blinatumomab
Amgen
injection2014

Competitive Landscape

17 companies ranked by most advanced pipeline stage

Amgen
AmgenTHOUSAND OAKS, CA
2 programs
2
1
BLINCYTO(Blinatumomab)Phase 2Monoclonal Antibody5 trials
BlinatumomabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT02187354No Longer Available
NCT07178912Not Yet Recruiting60Est. Sep 2033
NCT07313852Not Yet Recruiting26Est. Jan 2029
+3 more trials
Novartis
NovartisBASEL, Switzerland
4 programs
1
1
2
CTL019Phase 31 trial
TisagenlecleucelPhase 3Cell Therapy1 trial
TisagenlecleucelPhase 2Cell Therapy1 trial
Asciminib Adult formulationPhase 1/21 trial
Active Trials
NCT07387926Not Yet Recruiting50Est. Dec 2035
NCT04225676Terminated5Est. Oct 2021
NCT03123939Completed69Est. Oct 2020
+1 more trials
UP
UCB PharmaBelgium - Brussels
1 program
1
inotuzumab ozogamicinPhase 3ADC
Jazz Pharmaceuticals
Jazz PharmaceuticalsCA - Palo Alto
5 programs
1
2
1
IM JZP-458Phase 2/31 trial
asparaginase Erwinia chrysanthemiPhase 21 trial
pegcrisantaspasePhase 21 trial
ErwinasePhase 11 trial
Asparaginase Erwinia ChrysanthemiN/A1 trial
Active Trials
NCT04943952Approved For Marketing
NCT00693602Completed87Est. Dec 2011
NCT01643408Completed30Est. Dec 2013
+2 more trials
City Therapeutics
City TherapeuticsMA - Cambridge
3 programs
1
2
CyclophosphamidePhase 21 trial
VelcadePhase 21 trial
Allogeneic Hematopoietic Stem Cell TransplantationPhase 11 trial
Active Trials
NCT05139004Active Not RecruitingEst. Jun 2027
NCT05364762Active Not RecruitingEst. May 2026
NCT02535806TerminatedEst. May 2017
Precision BioSciences
2 programs
1
1
pCAR-19B cellsPhase 21 trial
pCAR-19B cellsPhase 11 trial
Active Trials
NCT04888468Completed9Est. Sep 2021
NCT05334823Recruiting100Est. Jul 2025
Pfizer
PfizerNEW YORK, NY
2 programs
2
852APhase 21 trial
CMC-544Phase 21 trial
Active Trials
NCT00276159Terminated6Est. Nov 2008
NCT01134575Completed90Est. Apr 2018
Takeda
TakedaTOKYO, Japan
1 program
1
DasatinibPhase 2Small Molecule1 trial
Active Trials
NCT04845035Withdrawn0Est. Jan 2029
Bristol Myers Squibb
1 program
1
JCAR015Phase 21 trial
Active Trials
NCT02535364Terminated82Est. Sep 2017
Astellas
AstellasChina - Shenyang
1 program
1
VCL-CB01Phase 21 trial
Active Trials
NCT00285259Completed112Est. Nov 2010
GS
Gilead SciencesFOSTER CITY, CA
1 program
1
EntospletinibPhase 1/2Small Molecule1 trial
Active Trials
NCT02404220Terminated30Est. Dec 2018
Acrotech Biopharma
Acrotech BiopharmaNJ - East Windsor
1 program
1
Vincristine Sulfate Liposomes InjectionPhase 1/21 trial
Active Trials
NCT00144963CompletedEst. Aug 2006
Leman Biotech
Leman BiotechChina - Shenzhen
2 programs
2
Metabolically Armed CD19 CAR-T cellsPhase 1Cell Therapy1 trial
Metabolically Armed CD19 CAR-T cellsPhase 1Cell Therapy1 trial
Active Trials
NCT06393335Recruiting36Est. Mar 2026
NCT06277011Unknown18Est. May 2025
AbbVie
AbbVieNORTH CHICAGO, IL
1 program
1
ABT-348Phase 1
ADC Therapeutics
ADC TherapeuticsNJ - New Providence
1 program
1
ADCT-402Phase 11 trial
Active Trials
NCT02669264Terminated35Est. Jul 2018
Knight Therapeutics
Knight TherapeuticsQC - Montréal
1 program
1
CyclophosphamidePhase 11 trial
Active Trials
NCT02779283Completed7Est. Sep 2018
Alliance Pharmaceuticals
1 program
6-MercaptopurineN/A1 trial
Active Trials
NCT01324336Completed40Est. Dec 2013

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
AmgenBlinatumomab
AmgenBlinatumomab
AmgenBlinatumomab
AmgenBlinatumomab
NovartisTisagenlecleucel
AmgenBlinatumomab
NovartisCTL019
AmgenBlinatumomab
AmgenBlinatumomab
Jazz PharmaceuticalsIM JZP-458
AmgenBlinatumomab
AmgenBlinatumomab
AmgenBlinatumomab
AmgenBlinatumomab
AmgenBlinatumomab

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 10,496 patients across 50 trials

NCT04506086AmgenBlinatumomab

Feasibility Study to Evaluate Outpatient Blinatumomab in Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL)

Start: Aug 2021Est. completion: Sep 202410 patients
Phase 4Terminated
NCT05327894AmgenBlinatumomab

Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia

Start: Dec 2022Est. completion: Sep 2030160 patients
Phase 3Recruiting
NCT04994717AmgenBlinatumomab

Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia

Start: Nov 2021Est. completion: Jul 2031304 patients
Phase 3Recruiting
NCT04307576AmgenBlinatumomab

A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia

Start: Jul 2020Est. completion: Jun 20336,430 patients
Phase 3Recruiting
NCT03628053NovartisTisagenlecleucel

Tisagenlecleucel vs Blinatumomab or Inotuzumab for Patients With Relapsed/Refractory B-cell Precursor Acute Lymphoblastic Leukemia

Start: Jun 2020Est. completion: Jan 20260
Phase 3Withdrawn
NCT03476239AmgenBlinatumomab

Efficacy and Safety of the BiTE Antibody Blinatumomab in Chinese Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)

Start: Oct 2017Est. completion: Apr 2021121 patients
Phase 3Completed
NCT03123939NovartisCTL019

Phase III B in Acute Lymphoblastic Leukemia

Start: Apr 2017Est. completion: Oct 202069 patients
Phase 3Completed
NCT02393859AmgenBlinatumomab

Phase 3 Trial of Blinatumomab vs Standard Chemotherapy in Pediatric Subjects With HIgh-Risk (HR) First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL)

Start: Nov 2015Est. completion: Nov 2022111 patients
Phase 3Completed
NCT02013167AmgenBlinatumomab

Blinatumomab Versus Standard of Care Chemotherapy in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)

Start: Jan 2014Est. completion: Mar 2017405 patients
Phase 3Terminated
NCT04145531Jazz PharmaceuticalsIM JZP-458

An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)

Start: Dec 2019Est. completion: Jul 2022229 patients
Phase 2/3Completed
NCT03117751AmgenBlinatumomab

Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma

Start: Mar 2017Est. completion: Sep 2028790 patients
Phase 2/3Active Not Recruiting
NCT02910063AmgenBlinatumomab

Study to Evaluate Safety and Efficacy of Blinatumomab in Subjects With Relapsed/Refractory (R/R) Aggressive B-Cell NHL

Start: Jan 2017Est. completion: Mar 202041 patients
Phase 2/3Completed
NCT07178912AmgenBlinatumomab

Phase II Study of the Combination of Subcutaneous Blinatumomab and Olverembatinib in Patients With Philadelphia Chromosome (ph)-Positive and/or BCR::ABL1 Positive Acute Lymphoblastic Leukemia (ALL)

Start: Aug 2026Est. completion: Sep 203360 patients
Phase 2Not Yet Recruiting
NCT07313852AmgenBlinatumomab

A Study of Inotuzumab and Blinatumomab in People With Newly Diagnosed B-cell Acute Lymphoblastic Leukemia

Start: Mar 2026Est. completion: Jan 202926 patients
Phase 2Not Yet Recruiting
NCT07192237AmgenBlinatumomab

Phase 2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Patients With Measurable Residual Disease Positive B-cell Acute Lymphoblastic Leukemia

Start: Feb 2026Est. completion: Oct 203240 patients
Phase 2Not Yet Recruiting
NCT07222579AmgenBlinatumomab

Subcutaneous Blinatumomab for Treatment of Adult Patients With CD19-Positive Mixed Phenotype Acute Leukemia (MPAL)

Start: Feb 2026Est. completion: Aug 203178 patients
Phase 2Recruiting
NCT07153796AmgenBlinatumomab

A Phase 2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Combination With Low Intensity Chemotherapy in Older Patients With Newly Diagnosed B-cell Acute Lymphoblastic Leukemia

Start: Jan 2026Est. completion: Sep 203360 patients
Phase 2Recruiting
NCT06570798AmgenBlinatumomab

A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases

Start: Jul 2025Est. completion: Mar 2029220 patients
Phase 2Recruiting
NCT06533748AmgenBlinatumomab

Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma

Start: Jan 2025Est. completion: May 2034128 patients
Phase 2Recruiting
NCT06054113AmgenBlinatumomab

Study of Blinatumomab Administration in Chinese Pediatric Participants With Relapsed/Refractory B Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)

Start: Jul 2024Est. completion: Oct 202718 patients
Phase 2Active Not Recruiting
NCT04845035TakedaDasatinib

Pediatric-Inspired Chemotherapy Plus Tyrosine Kinase Inhibitor in Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Start: Jan 2024Est. completion: Jan 20290
Phase 2Withdrawn
NCT05364762City TherapeuticsCyclophosphamide

Adding Itacitinib to Cyclophosphamide and Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Hematopoietic Stem Cell Transplants

Start: Nov 2022Est. completion: May 2026
Phase 2Active Not Recruiting
NCT05334823Precision BioSciencespCAR-19B cells

A Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents

Start: Jan 2022Est. completion: Jul 2025100 patients
Phase 2Recruiting
NCT04448834AmgenBlinatumomab

Blincyto Amgen Acrotech BioPharma PH2 Blincyto Marqibo R/R Philadelphi CD19+ ALL

Start: Jan 2022Est. completion: Jun 20230
Phase 2Withdrawn
NCT04746209AmgenBlinatumomab

Blinatumomab After TCR Alpha Beta/CD19 Depleted HCT

Start: Feb 2021Est. completion: Dec 202925 patients
Phase 2Recruiting
NCT04225676NovartisTisagenlecleucel

Study of Efficacy and Safety of Reinfusion of Tisagenlecleucel in Pediatric and Young Adult Patients With Acute Lymphoblastic Leukemia (ALL)

Start: Oct 2020Est. completion: Oct 20215 patients
Phase 2Terminated
NCT04044560AmgenBlinatumomab

Blinatumomab for MRD in Pre-B ALL Patients Following Stem Cell Transplant

Start: Sep 2020Est. completion: Feb 20228 patients
Phase 2Terminated
NCT04329325AmgenBlinatumomab

Blinatumomab and Tyrosine Kinase Inhibitor Therapy in People With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Start: Mar 2020Est. completion: Mar 202617 patients
Phase 2Active Not Recruiting
NCT03931642AmgenBlinatumomab

BLINAtumomab After R-CHOP Debulking Therapy for Patients With Richter Transformation

Start: Jul 2019Est. completion: Oct 202241 patients
Phase 2Completed
NCT03982992AmgenBlinatumomab

Allogeneic Donor Lymphocyte Infusions Combined With Blinatumomab

Start: Jun 2019Est. completion: Nov 20210
Phase 2Withdrawn
NCT03298412AmgenBlinatumomab

Effect of Blinatumomab on Minimal Residual Disease (MRD) in Diffuse Large B-Cell Lymphoma (DLBCL) Subjects Post Autologous Hematopoietic Stem Cell Transplantation (aHSCT)

Start: May 2018Est. completion: Sep 201910 patients
Phase 2Terminated
NCT03121534AmgenBlinatumomab

Ibrutinib, Nivolumab and Blinatumomab in Richter Transformation

Start: Jun 2017Est. completion: Feb 20229 patients
Phase 2Terminated
NCT02811679AmgenBlinatumomab

A Study Of Blinatumomab For The Treatment Of Relapsed Or Refractory Indolent Non-Hodgkin Lymphoma

Start: Aug 2016Est. completion: Dec 202313 patients
Phase 2Terminated
NCT02807883AmgenBlinatumomab

Blinatumomab Maintenance Following Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Lymphoblastic Leukemia

Start: Aug 2016Est. completion: Feb 202223 patients
Phase 2Completed
NCT02535364Bristol Myers SquibbJCAR015

Study Evaluating the Efficacy and Safety of JCAR015 in Adult B-cell Acute Lymphoblastic Leukemia (B-ALL)

Start: Aug 2015Est. completion: Sep 201782 patients
Phase 2Terminated
NCT02535806City TherapeuticsVelcade

Four Drug Reinduction With Bortezomib for Relapsed or Refractory ALL or LL in Children and Young Adults

Start: Jul 2015Est. completion: May 2017
Phase 2Terminated
NCT02257684Jazz Pharmaceuticalspegcrisantaspase

A Dose Confirmation and Pharmacokinetic Study of Pegcrisantaspase Administered as Intravenous (IV) Infusion in Children and Young Adults With Acute Lymphoblastic Leukemia (ALL) /Lymphoblastic Lymphoma (LBL). Following Hypersensitivity to Pegaspargase (Oncaspar)

Start: Sep 2014Est. completion: Jan 20164 patients
Phase 2Terminated
NCT02000427AmgenBlinatumomab

Blinatumomab in Adults With Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia

Start: Jan 2014Est. completion: Jan 201745 patients
Phase 2Completed
NCT01643408Jazz Pharmaceuticalsasparaginase Erwinia chrysanthemi

A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy

Start: Nov 2012Est. completion: Dec 201330 patients
Phase 2Completed
NCT01466179AmgenBlinatumomab

Clinical Study With Blinatumomab in Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)

Start: Dec 2011Est. completion: Jan 2017225 patients
Phase 2Completed
NCT01209286AmgenBlinatumomab

Study of the BiTE® Blinatumomab (MT103) in Adult Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)

Start: Oct 2010Est. completion: Oct 201636 patients
Phase 2Completed
NCT01134575PfizerCMC-544

CMC-544 in Relapsed Refractory Acute Lymphoblastic Leukemia (ALL)

Start: Jun 2010Est. completion: Apr 201890 patients
Phase 2Completed
NCT00560794AmgenBlinatumomab

Phase II Study of the BiTE® Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL)

Start: Jan 2008Est. completion: Nov 201421 patients
Phase 2Completed
NCT00285259AstellasVCL-CB01

Cytomegalovirus (CMV) Vaccine in Donors and Recipients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)

Start: Jan 2006Est. completion: Nov 2010112 patients
Phase 2Completed
NCT00276159Pfizer852A

Study of Immune Response Modifier in the Treatment of Hematologic Malignancies

Start: Jan 2006Est. completion: Nov 20086 patients
Phase 2Terminated
NCT07387926NovartisAsciminib Adult formulation

Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+) or ABL-class Ph-like Acute Lymphoblastic Leukemia (ALL)

Start: Mar 2026Est. completion: Dec 203550 patients
Phase 1/2Not Yet Recruiting
NCT07134088AmgenBlinatumomab

A Study of Subcutaneous Blinatumomab in Children With R/R and and MRD+ B-Cell Precursor Acute Lymphoblastic Leukemia

Start: Dec 2025Est. completion: Jun 2030104 patients
Phase 1/2Recruiting
NCT03114865AmgenBlinatumomab

A Study of Blinatumomab in Patients With Pre B-cell ALL and B-cell NHL as Post-allo-HSCT Remission Maintenance

Start: Sep 2017Est. completion: Jun 202644 patients
Phase 1/2Active Not Recruiting
NCT02412306AmgenBlinatumomab

Study of Blinatumomab in Japanese Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

Start: Jun 2015Est. completion: Jul 201966 patients
Phase 1/2Completed
NCT02404220Gilead SciencesEntospletinib

Safety and Efficacy of Entospletinib With Vincristine and Dexamethasone in Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)

Start: May 2015Est. completion: Dec 201830 patients
Phase 1/2Terminated

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

3 late-stage (Phase 3) programs — potential near-term approvals
10 actively recruiting trials targeting 10,496 patients
17 companies competing in this space

Related Indications

Breast Cancer(577)Prostate Cancer(385)Non-small Cell Lung Cancer(378)Multiple Myeloma(359)Cancer(249)Advanced Solid Tumors(226)Acute Myeloid Leukemia(209)Neoplasms(199)Colorectal Cancer(171)Melanoma(170)