MalignanciesPhase 1NCT03236857
A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies
A Phase 1 study testing chemotherapy and venetoclax in people with Malignancies and Acute Lymphoblastic Leukemia (ALL), run by AbbVie at 31 sites in 8 countries.
Trial summary
An open-label, global, multi-center study to evaluate the safety and pharmacokinetics of venetoclax monotherapy, to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of venetoclax in pediatric and young adult participants with relapsed or… Read more about this study
- Who is it for?
- Ages 0 to 25 years
- Conditions the study is for
- Malignancies, Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML)
- What is being tested?
- chemotherapy and venetoclax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 31 sitesin 8 countries
- Study dates
- 8 Nov 2017to 19 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants must have relapsed or refractory cancer.
- Participants must have adequate hepatic and kidney function.
- Participants less than or equal to 16 years of age must have performance status of Lansky greater than or equal to 50% and participants greater than 16 years of age must have performance status of Karnofsky greater than or equal to 50%.
- Participants with solid tumors (with the exception of neuroblastoma) must have adequate bone marrow function in Part 1.
- For the fifth cohort during Part 2 Cohort Expansion, participants with solid tumors must have evidence of BCL-2 expression (except participants with TCF3-HLF ALL).
Who cannot join
- Participants with primary brain tumors or disease metastatic to the brain.
- Participants who have central nervous system (CNS) disease with cranial involvement that requires radiation.
- Participants who have received any of the following within the listed time frame, prior to the first dose of study drug
- Inotuzumab ozogamicin or gemtuzumab ozogamicin within 30 days
- Biologic agent (i.e., antibodies) for anti-neoplastic intent within 30 days or 5 half-lives whichever is shorter.
- CAR-T infusion or other cellular therapy within 30 days
Show all 18Show fewer
- Anticancer therapy including chemotherapy, radiation therapy, targeted small molecule agents, investigational agents within 14 days or 5 half-lives, whichever is shorter (Exceptions: Ph+ALL participants on Tyrosine Kinase Inhibitor (TKI) at Screening may enroll and remain on TKI therapy to control disease and TCF3-HLF ALL participants are allowed to have received chemotherapy within 14 days or 5 half-lives, whichever is shorter).
- Steroid therapy for anti-neoplastic intent within 5 days (with the exception of TCF3-HLF ALL participants).
- Requires ongoing hydroxyurea (hydroxyurea permitted up to first dose)
- Participants who are less than 100 days post-transplant, or greater than or equal to 100 days post-transplant with active graft versus host disease (GVHD), or are receiving immunosuppressant therapy within 7 days prior to first dose of study drug.
- Participants who are less than 6 weeks post-131 I-metaiodobenzylguanidine (mIBG) therapy.
- Participants who have received the following within 7 days prior to the first dose of study drug:
- Strong and moderate Cytochrome P450 3A (CYP3A) inhibitors (Part 1 Dose Determination);
- Strong and moderate CYP3A inducers (Part 1 Dose Determination and Part 2 Cohort Expansion).
- Participants who have not recovered from clinically significant adverse effect(s)/toxicity(s) of the previous therapy (Exception: Chemotherapy induced side effects that are expected to return to baseline in TCF3-HLF ALL participants).
- Participants who have active, uncontrolled infections.
- Participants with malabsorption syndrome or any other condition that precludes enteral administration.
- Participants with recent positive test for SARS-CoV-2 (COVID-19) and no follow up test with negative result cannot be enrolled. Participants with contact to persons with COVID-19 and participants with signs and symptoms for COVID-19 infection must be tested before enrolling.
Trial locations and contacts
31 sites in 8 countries.
31 sites in 8 countries
United States11 sites
Children's Healthcare of Atlan /ID# 161552
Atlanta, Georgia, 30322
Children's Hospital Colorado /ID# 161551
Aurora, Colorado, 80045
Dana-Farber Cancer Institute /ID# 163440
Boston, Massachusetts, 02215
Cincinnati Children's Hospital /ID# 161550
Cincinnati, Ohio, 45229
St Jude Children's Research Hospital /ID# 163447
Memphis, Tennessee, 38105
Medical College of Wisconsin /ID# 163461
Milwaukee, Wisconsin, 53226-3522
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 163444
New York, New York, 10065-6007
Children's Hospital of Philadelphia /ID# 163445
Philadelphia, Pennsylvania, 19104
Primary Children's /ID# 164399
Salt Lake City, Utah, 84113
Univ California, San Francisco /ID# 163460
San Francisco, California, 94143-2204
Seattle Children's Hospital /ID# 163459
Seattle, Washington, 98105
France5 sites
Centre Leon Berard /ID# 163707
Lyon, Rhone, 69373
AP-HM - Hopital de la Timone /ID# 161465
Marseille, Bouches-du-Rhone, 13385
AP-HP - Hopital Armand-Trousseau /ID# 163728
Paris, 75012
Robert Debre Hopital, FR /ID# 161464
Paris, 75019
CHU Toulouse - Hôpital des enfants /ID# 163727
Toulouse, 31059
Australia4 sites
Women and Childrens Hospital /ID# 163147
North Adelaide, South Australia, 5006
Royal Children's Hospital /ID# 163104
Parkville, Victoria, 3052
Sydney Children's Hospital /ID# 163148
Randwick, New South Wales, 2031
Queensland Children's Hospital /ID# 163146
South Brisbane, Queensland, 4101
Germany4 sites
Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 161730
Berlin, 13353
Universitaetsklinikum Essen /ID# 164207
Essen, 45147
Universitaetsklinikum Freiburg /ID# 164206
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 161729
Kiel, Schleswig-Holstein, 24105
Canada2 sites
CHU Sainte-Justine /ID# 163725
Montreal, Quebec, H3T 1C5
Hospital for Sick Children /ID# 163726
Toronto, Ontario, M5G 1X8
Netherlands2 sites
Erasmus MC - Sophia /ID# 161579
Rotterdam, 3015 GD
Prinses Maxima Centrum /ID# 162670
Utrecht, 3584 CS
United Kingdom2 sites
Great Ormond Street Hospital for Children /ID# 169238
London, London, City of, WC1N 3JH
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 162938
Newcastle upon Tyne, NE7 7DN
Switzerland1 site
Kinderspital Zurich - Eleonorenstiftung /ID# 163037
Zurich, Canton of Zurich, 8032
About this study
Official title: A Phase 1 Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies
An open-label, global, multi-center study to evaluate the safety and pharmacokinetics of venetoclax monotherapy, to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of venetoclax in pediatric and young adult participants with relapsed or refractory malignancies.
- Conditions
- Malignancies, Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Non-Hodgkin's Lymphoma, Neuroblastoma
- Being tested
- chemotherapy, venetoclax
- Keywords
- Cancer, Venetoclax, pediatric, relapsed or refractory, Venclexta
- Medical subject headings
- Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Lymphoma, Non-Hodgkin, Neuroblastoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapyDrug
Dexamethasone and/or vincristine and/or pegasparaginase OR cytarabine and/or etoposide and/or pegasparaginase; tyrosine kinase inhibitor; cytarabine OR azacitidine OR decitabine; rituximab and/or dexamethasone and/or vincristine; cyclophosphamide and/or topotecan
venetoclaxDrug
Also called ABT-199, GDC-0199, Venclexta
Oral tablet for participants; Tablet for oral suspension (participants who cannot swallow a tablet)
| Study group | Role | What they receive |
|---|---|---|
| Venetoclax with or without chemotherapy | Experimental | Venetoclax administered orally once daily (QD) with various doses and dosing regimens with or without chemotherapy at the discretion of the investigator. Allowed chemotherapy regimens as outlined in the study protocol. Receives: Drug: chemotherapy; Drug: venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Measured: Up to 9 months
Number of Participants With Dose Limiting Toxicities (DLT) of Venetoclax Monotherapy
A DLT is any Grade 3 or higher non-hematologic adverse event (AE) with exceptions outlined in the protocol.
Measured: First 21 days venetoclax monotherapy
Recommended Phase 2 dose (RPTD) of Venetoclax
Venetoclax RPTD is the dose determined based on adverse event reporting and dose-limiting toxicity information from all participants.
Measured: First 21 days venetoclax monotherapy
Cmax of Venetoclax
Maximum plasma concentration (Cmax) of venetoclax.
Measured: Up to approximately 2 weeks
Tmax of venetoclax
Time to maximum plasma concentration (Tmax) of venetoclax.
Measured: Up to approximately 2 weeks
AUC0-24 Post-Dose of Venetoclax
Area under the plasma concentration-time curve from 0 to 24 hours (AUC24) post-dose of venetoclax.
Measured: Up to approximately 2 weeks
Secondary outcomes (3)
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who achieved a response according to established criteria described in detail in the study protocol.
Measured: Up to 9 months
Partial Response (PR) Rate
PR is defined according to established criteria for each tumor type and is described in detail within the study protocol.
Measured: Up to 9 months
Complete Response (CR) Rate
CR is defined according to established criteria for each tumor type and is described in detail within the study protocol.
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start8 Nov 2017
- Primary completion19 Apr 2023
- Study completion19 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for MalignanciesStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Roche-Genentech
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236857
- Sponsor's protocol ID
- M13-833
- Other IDs
- 2017-000439-14, 2017
- Status last verified
- Nov 2022
- First submitted
- 31 Jul 2017
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Publications
Karol SE, Khaw SL, Zwaan CM, Baruchel A, Bittencourt H, Cooper TM, Flotho C, Fraser C, Forlenza CJ, Goldsmith KC, Macy ME, Morgenstern DA, O'Brien MM, Petit A, Ziegler DS, Reinhardt D, Opferman JT, Rubnitz JE, Onishi M, Dunshee DR, Dunbar F, Vishwamitra D, Ross JA, Chen X, Unnebrink K, Kammerlander M, Salem AH, Palenski TL, Sunkersett G, Place AE. Venetoclax Alone or in Combination With Chemotherapy in Paediatric and Adolescent/Young Adult Patients With Relapsed/Refractory Acute Myeloid Leukaemia. Pediatr Blood Cancer. 2025 Jul;72(7):e31714. doi: 10.1002/pbc.31714. Epub 2025 Apr 23.
PubMed 40266036Place AE, Karol SE, Forlenza CJ, Cooper TM, Fraser C, Cario G, O'Brien MM, Gerber NU, Bourquin JP, Reinhardt D, Rubnitz JE, Opferman JT, Sunkersett G, Onishi M, Dunshee DR, Chen X, Unnebrink K, Vishwamitra D, Dunbar F, Badawi M, Ross JA, Loh ML. Venetoclax Combined With Chemotherapy in Pediatric and Adolescent/Young Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia. Pediatr Blood Cancer. 2025 Jun;72(6):e31630. doi: 10.1002/pbc.31630. Epub 2025 Mar 10.
PubMed 40062648Badawi M, Gopalakrishnan S, Engelhardt B, Palenski T, Karol SE, Rubnitz JE, Menon R, Salem AH. Dosing of Venetoclax in Pediatric Patients with Relapsed Acute Myeloid Leukemia: Analysis of Developmental Pharmacokinetics and Exposure-Response Relationships. Clin Ther. 2024 Oct;46(10):759-767. doi: 10.1016/j.clinthera.2024.09.008. Epub 2024 Oct 5.
PubMed 39368878Dalton KM, Krytska K, Lochmann TL, Sano R, Casey C, D'Aulerio A, Khan QA, Crowther GS, Coon C, Cai J, Jacob S, Kurupi R, Hu B, Dozmorov M, Greninger P, Souers AJ, Benes CH, Mosse YP, Faber AC. Venetoclax-based Rational Combinations are Effective in Models of MYCN-amplified Neuroblastoma. Mol Cancer Ther. 2021 Aug;20(8):1400-1411. doi: 10.1158/1535-7163.MCT-20-0710. Epub 2021 Jun 4.
PubMed 34088831Place AE, Goldsmith K, Bourquin JP, Loh ML, Gore L, Morgenstern DA, Sanzgiri Y, Hoffman D, Zhou Y, Ross JA, Prine B, Shebley M, McNamee M, Farazi T, Kim SY, Verdugo M, Lash-Fleming L, Zwaan CM, Vormoor J. Accelerating drug development in pediatric cancer: a novel Phase I study design of venetoclax in relapsed/refractory malignancies. Future Oncol. 2018 Sep;14(21):2115-2129. doi: 10.2217/fon-2018-0121. Epub 2018 Mar 29.
PubMed 29595064
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies
- ClinicalTrials.gov ID
- NCT03236857
- Acronym / sponsor ID
- M13-833
- Conditions
- Malignancies, Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Non-Hodgkin's Lymphoma, Neuroblastoma
- Keywords
- Cancer, Venetoclax, pediatric, relapsed or refractory, Venclexta
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Collaborators
- Roche-Genentech
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 19 Apr 2023 (actual)
- First posted
- 2 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label, global, multi-center study to evaluate the safety and pharmacokinetics of venetoclax monotherapy, to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of venetoclax in pediatric and young adult participants with relapsed or refractory malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venetoclax with or without chemotherapy | Experimental | Drug: chemotherapy, Drug: venetoclaxVenetoclax administered orally once daily (QD) with various doses and dosing regimens with or without chemotherapy at the discretion of the investigator. Allowed chemotherapy regimens as outlined in the study protocol. |
Who may qualify
- Ages
- 0 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Participants must have relapsed or refractory cancer.
- Participants must have adequate hepatic and kidney function.
- Participants less than or equal to 16 years of age must have performance status of Lansky greater than or equal to 50% and participants greater than 16 years of age must have performance status of Karnofsky greater than or equal to 50%.
- Participants with solid tumors (with the exception of neuroblastoma) must have adequate bone marrow function in Part 1.
- For the fifth cohort during Part 2 Cohort Expansion, participants with solid tumors must have evidence of BCL-2 expression (except participants with TCF3-HLF ALL).
Key exclusion criteria (18 listed)
- Participants with primary brain tumors or disease metastatic to the brain.
- Participants who have central nervous system (CNS) disease with cranial involvement that requires radiation.
- Participants who have received any of the following within the listed time frame, prior to the first dose of study drug
- Participants who are less than 100 days post-transplant, or greater than or equal to 100 days post-transplant with active graft versus host disease (GVHD), or are receiving immunosuppressant therapy within 7 days prior to first dose of study drug.
- Participants who are less than 6 weeks post-131 I-metaiodobenzylguanidine (mIBG) therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chemotherapyDexamethasone and/or vincristine and/or pegasparaginase OR cytarabine and/or etoposide and/or pegasparaginase; tyrosine kinase inhibitor; cytarabine OR azacitidine OR decitabine; rituximab and/or dexamethasone and/or vincristine; cyclophosphamide and/or topotecan | Drug | Venetoclax with or without chemotherapy |
| venetoclaxAlso: ABT-199, GDC-0199, VenclextaOral tablet for participants; Tablet for oral suspension (participants who cannot swallow a tablet) | Drug | Venetoclax with or without chemotherapy |
Primary outcome
Number of Participants Experiencing Adverse Events
Time frame: Up to 9 months
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Number of Participants With Dose Limiting Toxicities (DLT) of Venetoclax Monotherapy
Time frame: First 21 days venetoclax monotherapy
A DLT is any Grade 3 or higher non-hematologic adverse event (AE) with exceptions outlined in the protocol.
Recommended Phase 2 dose (RPTD) of Venetoclax
Time frame: First 21 days venetoclax monotherapy
Venetoclax RPTD is the dose determined based on adverse event reporting and dose-limiting toxicity information from all participants.
Cmax of Venetoclax
Time frame: Up to approximately 2 weeks
Maximum plasma concentration (Cmax) of venetoclax.
Tmax of venetoclax
Time frame: Up to approximately 2 weeks
Time to maximum plasma concentration (Tmax) of venetoclax.
AUC0-24 Post-Dose of Venetoclax
Time frame: Up to approximately 2 weeks
Area under the plasma concentration-time curve from 0 to 24 hours (AUC24) post-dose of venetoclax.
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 9 months
Partial Response (PR) Rate
Time frame: Up to 9 months
Complete Response (CR) Rate
Time frame: Up to 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Derived from this study: PubMed 40266036Karol SE, Khaw SL, Zwaan CM, Baruchel A, Bittencourt H, Cooper TM, Flotho C, Fraser C, Forlenza CJ, Goldsmith KC, Macy ME, Morgenstern DA, O'Brien MM, Petit A, Ziegler DS, Reinhardt D, Opferman JT, Rubnitz JE, Onishi M, Dunshee DR, Dunbar F, Vishwamitra D, Ross JA, Chen X, Unnebrink K, Kammerlander M, Salem AH, Palenski TL, Sunkersett G, Place AE. Venetoclax Alone or in Combination With Chemotherapy in Paediatric and Adolescent/Young Adult Patients With Relapsed/Refractory Acute Myeloid Leukaemia. Pediatr Blood Cancer. 2025 Jul;72(7):e31714. doi: 10.1002/pbc.31714. Epub 2025 Apr 23.
- Derived from this study: PubMed 40062648Place AE, Karol SE, Forlenza CJ, Cooper TM, Fraser C, Cario G, O'Brien MM, Gerber NU, Bourquin JP, Reinhardt D, Rubnitz JE, Opferman JT, Sunkersett G, Onishi M, Dunshee DR, Chen X, Unnebrink K, Vishwamitra D, Dunbar F, Badawi M, Ross JA, Loh ML. Venetoclax Combined With Chemotherapy in Pediatric and Adolescent/Young Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia. Pediatr Blood Cancer. 2025 Jun;72(6):e31630. doi: 10.1002/pbc.31630. Epub 2025 Mar 10.
- Derived from this study: PubMed 39368878Badawi M, Gopalakrishnan S, Engelhardt B, Palenski T, Karol SE, Rubnitz JE, Menon R, Salem AH. Dosing of Venetoclax in Pediatric Patients with Relapsed Acute Myeloid Leukemia: Analysis of Developmental Pharmacokinetics and Exposure-Response Relationships. Clin Ther. 2024 Oct;46(10):759-767. doi: 10.1016/j.clinthera.2024.09.008. Epub 2024 Oct 5.
- Derived from this study: PubMed 34088831Dalton KM, Krytska K, Lochmann TL, Sano R, Casey C, D'Aulerio A, Khan QA, Crowther GS, Coon C, Cai J, Jacob S, Kurupi R, Hu B, Dozmorov M, Greninger P, Souers AJ, Benes CH, Mosse YP, Faber AC. Venetoclax-based Rational Combinations are Effective in Models of MYCN-amplified Neuroblastoma. Mol Cancer Ther. 2021 Aug;20(8):1400-1411. doi: 10.1158/1535-7163.MCT-20-0710. Epub 2021 Jun 4.
- Derived from this study: PubMed 29595064Place AE, Goldsmith K, Bourquin JP, Loh ML, Gore L, Morgenstern DA, Sanzgiri Y, Hoffman D, Zhou Y, Ross JA, Prine B, Shebley M, McNamee M, Farazi T, Kim SY, Verdugo M, Lash-Fleming L, Zwaan CM, Vormoor J. Accelerating drug development in pediatric cancer: a novel Phase I study design of venetoclax in relapsed/refractory malignancies. Future Oncol. 2018 Sep;14(21):2115-2129. doi: 10.2217/fon-2018-0121. Epub 2018 Mar 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
31 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing chemotherapy and venetoclax in people with Malignancies and Acute Lymphoblastic Leukemia (ALL), run by AbbVie at 31 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, France, Australia, Germany, Canada and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Adverse Events (time frame: Up to 9 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03236857, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.