Testing the Combination of Inotuzumab Ozogamicin and Lower Dose Chemotherapy Compared to Usual Chemotherapy for Adults With B-Cell Acute Lymphoblastic Leukemia or B-Cell Lymphoblastic Lymphoma

• ClinicalTrials.gov Identifier: NCT05303792
• Recruitment Status: Recruiting
• First Posted: March 31, 2022
• Last Update Posted: November 1, 2023
• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Alliance for Clinical Trials in Oncology

Study Description

Brief Summary:

This phase II trial compares the combination of inotuzumab ozogamicin and chemotherapy to the usual chemotherapy in treating patients with B-cell acute lymphoblastic leukemia or B-cell lymphoblastic lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a drug, called CalichDMH. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers CalichDMH to kill them. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may help shrink the cancer and stop it from returning.

Condition or disease	Intervention/treatment	Phase
B Acute Lymphoblastic Leukemia; B Lymphoblastic Lymphoma	Drug: Cyclophosphamide; Drug: Vincristine; Drug: Dexamethasone; Biological: Inotuzumab Ozogamicin; Drug: Methotrexate; Drug: Cytarabine; Drug: Methylprednisolone; Biological: Rituximab; Drug: Prednisone; Drug: Mercaptopurine; Drug: Doxorubicin	Phase 2

Detailed Description:

PRIMARY OBJECTIVE:

I. To compare undetectable measurable residual disease (MRD) event-free survival (EFS) rate of the experimental arm (A) to standard arm (B) with EFS defined as time from randomization to occurrence of an event.

SECONDARY OBJECTIVES:

I. To determine overall response rate (complete response [CR], CR + complete remission with incomplete platelet counts [CRp], CR + complete remission with partial hematologic recovery [CRh], CR + complete remission with incomplete blood count recovery [CRi]) at designated time points (after cycle 1, after cycle 2, end of intensive phase) in each treatment arm.

II. To determine rate of flow cytometry MRD-negativity (undetectable or detectable < 10^-4) at designated time points (after cycle 1, after cycle 2, end of intensive phase) in each treatment arm.

III. To compare MRD response by central aspirate multiparameter flow cytometry (Wood lab) to next generation sequencing MRD assessment (clonoSEQ, Adaptive) of blood and bone marrow at designated time points (after cycle 1, after cycle 2, and end of intensive phase) and to determine association with outcome, in each treatment arm.

IV. To determine the event-free survival (EFS) standard-definition (event defined as failure to achieve morphologic remission by cycle 2, hematologic relapse, death), disease-free survival (DFS), overall survival (OS) of each arm (median, 6-month, 1-year, 2-year, 3-year) in each treatment arm.

V. To determine proportion of patients who proceed to allogeneic transplant after initial response (without intervening salvage therapy) in each treatment arm.

VI. To determine rate of liver toxicity (grade 3-5 alanine aminotransferase [ALT] increase, aspartate aminotransferase [AST] increase, bilirubin increase, alkaline phosphatase increase).

VII. To describe the safety and tolerability of each arm including rate of grade 3-5 non-hematologic toxicity and treatment-related mortality (grade 5 toxicity VIII. To determine rate of delays in intensive-phase chemotherapy due to neutropenia and thrombocytopenia (in responding patients).

IX. To assess the baseline variations in comorbidity burden, physical, nutritional, and cognitive function of the study participants, and explore the association between comorbidity burden, physical, nutritional, and cognitive function, and the outcomes of therapy (grade 3-5 non-hematological toxicities, and OS).

X. To explore the longitudinal changes in physical, nutritional, and cognitive function among the experimental and control groups.

XI. To compare the burden of patient-reported symptomatic adverse events between treatment arms using the Patient Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE).

XII. To correlate specific karyotype groups (normal or various primary and secondary chromosomal abnormalities) with clinical and laboratory parameters.

XIII. To correlate specific karyotype groups with response rates, response duration, MRD, and survival in patients treated on this study.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A:

INDUCTION: Patients receive cyclophosphamide intravenously (IV) over 3 hours every 12 hours (Q12H) on days 1-3 of cycles 1, 3, 5, and 7, vincristine IV on days 1 and 8 of cycle 1, 3, 5, and 7, dexamethasone IV or orally (PO) on days 1-4 and 11-14 of cycles 1, 3, 5, and 7, inotuzumab ozogamicin IV over 1 hour on days 2 and 8 of cycles 1-4, methotrexate IV over 24 hours on day 1 of cycles 2, 4, 6, and 8, cytarabine IV over 3 hours Q12H on days 2-3 of cycles 2, 4, 6, and 8, and methylprednisolone IV over 2 hours Q12H on days 1-3. Patients with leukemic blasts expressing CD20 also receive rituximab IV on days 2 and 8 of cycles 1-4. For patients >= 70 years of age, treatment repeats every 28 days for 2 cycles (an additional 2 cycles may be given at the discretion of the principal investigator [PI]) in the absence of disease progression or unacceptable toxicity. For patients < 70 years of age, treatment repeats every 28 days for 8 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients receive vincristine IV on day 1, prednisone PO daily on days 1-5, mercaptopurine PO twice daily (BID) on days 1-28, and methotrexate PO weekly. Treatment repeats every 28 days for up to 24 cycles or 2 years, whichever comes first, in the absence of disease progression or unacceptable toxicity.

ARM B:

INDUCTION: Patients receive cyclophosphamide IV over 3 hours Q12H on days 1-3 of cycle 1, 3, 5, and 7, vincristine IV on days 1 and 8 of cycles 1, 3, 5, and 7, dexamethasone IV or PO on days 1-4 and 11-14 of cycle 1, 3, 5, and 7, doxorubicin IV over 24 hours on day 4 of cycles 1, 3, 5, and 7, methotrexate IV over 24 hours on day 1 of cycles 2, 4, 6, and 8, cytarabine IV over 3 hours Q12H on days 2-3 of cycles 2, 4, 6, and 8, and methylprednisolone IV over 2 hours Q12H on days 1-3 of cycles 2, 4, 6, and 8. Patients with leukemic blasts expressing CD20 also receive rituximab IV on days 2 and 8 of cycles 1-4. For patients >= 70 years of age, treatment repeats every 28 days for 2 cycles (an additional 2 cycles may be given at the discretion of the PI) in absence of disease progression or unacceptable toxicity. For patients < 70 years of age, treatment repeats every 28 days for 8 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients receive vincristine IV on day 1, prednisone PO daily on days 1-5, mercaptopurine PO BID on days 1-28, and methotrexate PO weekly. Treatment repeats every 28 days for up to 24 cycles or 2 years, whichever comes first, in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 2 months until 1 year after completion of therapy, every 3 months until 2 years after completion of therapy, and then every 6 months until 5 years from study registration.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Phase II Study Comparing Inotuzumab Plus Chemotherapy Versus Standard Chemotherapy in Older Adults With Philadelphia-Chromosome-Negative B-Cell Acute Lymphoblastic Leukemia
• Actual Study Start Date: February 27, 2023
• Estimated Primary Completion Date: May 2028
• Estimated Study Completion Date: May 2028

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm A (inotuzumab ozogamicin, chemotherapy); Induction: For cycles 1-4 on days 2 and 8, patients receive inotuzumab ozogamicin IV and IT chemotherapy consisting of alternating Cytarabine and Methotrexate. Patients with leukemic blasts expressing CD20 also receive rituximab IV on days 2 and 8 of cycles 1-4. For cycles 1,3,5,7, patients receive cyclophosphamide intravenously (IV) on days 1-3, mesna IV, vincristine IV on days 1 and 8, and dexamethasone IV or orally (PO) on days 1-4 and 11-14. For cycles 2,4,6,8, patients receive methotrexate on day 1, cytarabine IV on days 2-3, and methylprednisolone on days 1-3. Patients >= 70 years of age receive either 2 or 4 cycles of treatment. Patients < 70 years of age receive up to 8 cycles of treatment. Maintenance: Patients receive vincristine IV on day 1, prednisone PO on days 1-5, mercaptopurine PO on days 1-28, and methotrexate PO weekly. Treatment occurs for up to 24 cycles or 2 years, whichever comes first, in the absence of disease progression or unacceptable toxicity.	Drug: Cyclophosphamide; Given IV; Drug: Vincristine; Given IV; Drug: Dexamethasone; Given IV or PO; Biological: Inotuzumab Ozogamicin; Given IV; Drug: Methotrexate; Given IV or PO; Drug: Cytarabine; Given IV; Drug: Methylprednisolone; Given IV; Biological: Rituximab; Given IV; Drug: Prednisone; Given PO; Drug: Mercaptopurine; Given PO
Active Comparator: Arm B (chemotherapy); Induction: For cycles 1-4 on days 2 and 8, patients receive IT chemotherapy consisting of alternating Cytarabine and Methotrexate. Patients with leukemic blasts expressing CD20 also receive rituximab IV on days 2 and 8 of cycles 1-4. For cycles 1,3,5,7, patients receive cyclophosphamide intravenously (IV) on days 1-3, mesna IV, doxorubicin IV on day 4, vincristine IV on days 1 and 8, and dexamethasone IV or orally (PO) on days 1-4 and 11-14. For cycles 2,4,6,8, patients receive methotrexate on day 1, cytarabine IV on days 2-3, and methylprednisolone on days 1-3. Patients >= 70 years of age receive either 2 or 4 cycles of treatment. Patients < 70 years of age receive up to 8 cycles of treatment. Maintenance: Patients receive vincristine IV on day 1, prednisone PO on days 1-5, mercaptopurine PO on days 1-28, and methotrexate PO weekly. Treatment occurs for up to 24 cycles or 2 years, whichever comes first, in the absence of disease progression or unacceptable toxicity.	Drug: Cyclophosphamide; Given IV; Drug: Vincristine; Given IV; Drug: Dexamethasone; Given IV or PO; Drug: Methotrexate; Given IV or PO; Drug: Cytarabine; Given IV; Drug: Methylprednisolone; Given IV; Biological: Rituximab; Given IV; Drug: Prednisone; Given PO; Drug: Mercaptopurine; Given PO; Drug: Doxorubicin; Given IV

Outcome Measures

Primary Outcome Measures :

1. Event-free survival [ Time Frame: From randomization to failure to achieve measurable residual disease (MRD)-negative complete response (CR) after two cycles of chemotherapy, relapse, or death from any causes, assessed at 2 months (after 2 cycles of treatment) ]
   Will be evaluated using the methods of Kaplan-Meier as well as Cox regression models.

Secondary Outcome Measures :

1. Disease-free survival [ Time Frame: Time from achieving a CR/ complete remission with incomplete blood count recovery (CRi) to the time of relapse and/or death, assessed up to 5 years ]
   Will be evaluated using the methods of Kaplan-Meier as well as Cox regression models.
2. Overall survival [ Time Frame: From randomization to the time of death due to any cause, assessed up to 5 years ]
   Will be evaluated using the methods of Kaplan-Meier as well as Cox regression models.
3. Complete remission rate [ Time Frame: Up to 5 years ]
   The proportion of patients who achieve complete remission or any response to induction therapy will be summarized as the proportion of patients who achieve any type of response to induction therapy divided by the number of all evaluable patients registered to this trial and who received at least one dose of induction therapy. Corresponding 95% binomial confidence intervals will also be calculated. In a similar manner, the investigators will also evaluate the overall induction response rates. All evaluable patients will be used for this analysis.
4. Overall response rate [ Time Frame: Up to 5 years ]
   Overall response rate (CR/CRi, CR/complete remission with incomplete platelet counts [CRp], CR/complete remission with partial hematologic recovery [CRh]). The proportion of patients who achieve complete remission or any response to induction therapy will be summarized as the proportion of patients who achieve any type of response to induction therapy divided by the number of all evaluable patients registered to this trial and who received at least one dose of induction therapy. Corresponding 95% binomial confidence intervals will also be calculated. In a similar manner, the investigators will also evaluate the overall induction response rates. All evaluable patients will be used for this analysis.
5. MRD-negativity rate [ Time Frame: Up to end of cycle 8 (1 cycle = 28 days) ]
   MRD-negativity by flow cytometry will be evaluated at designated time point (after cycle 1, after cycle 2, end of intensive phase). Will also compare MRD assessment by centralized aspirate flow cytometry (Wood lab) to next generation sequencing (clonoSEQ, Adaptive) of blood and bone marrow at designated time points; and determine association with outcome.
6. Event-free survival [ Time Frame: Up to 5 years ]
   Event defined as failure to achieve Complete Response (CR)/Complete Remission with Incomplete Blood Count Recovery (CRi)/Complete Remission with Partial Hematological Recovery (CRh)/Complete Remission with Incomplete Platelet Counts (CRp), relapse, death.
7. Rate of grade 3-5 adverse events [ Time Frame: Up to 5 years ]
   The proportion of patients experiencing a grade 3+ adverse events or toxicities will be described for each treatment arm, but will also be compared between the arms using Fisher's exact tests.

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• PRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 0)

• Research bone marrow or peripheral blood submission

  * This bone marrow or peripheral blood submission is mandatory prior to registration/randomization as baseline for real-time MRD analysis. The bone marrow sample should be from the first aspiration (i.e., first pull). Aspirate needle should be redirected if needed to get first pull bone marrow aspirate. It should be obtained as soon after pre-registration as possible

• REGISTRATION INCLUSION CRITERIA (STEP 1)

• Diagnosis of B-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) per World Health Organization (WHO) 2016 criteria. Patients must have >= 5% blasts in the bone marrow or blood. Patients with lymphoblastic lymphoma (LBL) without measurable marrow involvement (>= 5% blasts) are not eligible

  * T-cell ALL/LBL, Philadelphia-chromosome positive B-cell (as determined by fluorescence in situ hybridization [FISH], cytogenetics, or reverse transcriptase polymerase chain reaction [RT-PCR]), and Burkitt's like leukemia/lymphoma (mature B-ALL) are not eligible

• Must be CD22 positive by local assessment (>= 20% by immunohistochemistry or flow cytometry). Patients are eligible regardless of CD20 status but CD20 expression should be assessed at diagnosis by flow cytometry or immunohistochemistry
• Patients must have >= 5% blasts in the bone marrow or blood. Patients with lymphoblastic lymphoma (LBL) without marrow involvement (>= 5% blasts) are not eligible
• No prior chemotherapy for ALL except for hydroxyurea (no limit), steroids limited to 7 days, ATRA (no limit), vincristine (single dose), and/or intra-thecal chemotherapy. Leukapheresis is permitted. Palliative radiation to doses 24 Gy or less is permitted. Patients being treated with chronic steroids for other reasons (autoimmune disorder, etc.) are eligible
• Age >= 50 years
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2. ECOG 3 permitted if related to disease
• Creatinine =< 2.0 g/dL

• Total bilirubin =< 1.5 x upper limit of normal (ULN)

  * Except in the event of: 1) Gilbert disease, in which case total bilirubin must be =< 2 x ULN, or 2) elevated bilirubin believed by investigator to be due to leukemic infiltration, in which case total bilirubin must be =< 2 x ULN

• AST / ALT =< 2.5 x upper limit of normal (ULN)
• Cardiac ejection fraction (as measured by multigated acquisition scan [MUGA] or echocardiogram) > 40%

• No clinically relevant liver disease (such as cirrhosis, active hepatitis, or alcohol use disorder), which in the opinion of the treating physician would make this protocol unreasonably hazardous

  • Patients with known hepatitis B virus (HBV) infection are eligible if they are on effective HBV suppressive therapy with undetectable HBV viral load and there is no clinically relevant liver disease present (related or unrelated to HBV-related liver damage)
  • Patients with known history of hepatitis C virus (HCV) infection are eligible if they have cleared the infection spontaneously or via eradication therapy (HCV viral load undetectable) and there is no clinically relevant liver disease present (related or unrelated to HCV-related liver damage)
• Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. Include as applicable: Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom)

Exclusion Criteria:

• Physicians should consider whether any of the following may render the patient inappropriate for this protocol:

  • Medical condition such as uncontrolled diabetes mellitus, uncontrolled cardiac disease, and uncontrolled pulmonary disease.
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • Patients with a "currently active" second malignancy other than non-melanoma skin cancers, early stage prostate cancer, cervical carcinoma in situ, or other cancer for which standard of care would be observation (not requiring treatment). Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for >= 1 year, or if the cancer has been surgically resected and considered cured. Patients with a history of multiple myeloma with absence of serum paraprotein for >= 1 year are not considered to have a "currently active" malignancy.
• REGISTRATION EXCLUSION CRITERIA (STEP 1)
• Patients with symptomatic central nervous system (CNS) disease are not eligible. CNS assessment is not required for eligibility determination if asymptomatic

Contacts and Locations

Contacts

Contact: Marlise R. Luskin, MD, MSCE; 617-632-2168; marlise_luskin@dfci.harvard.edu

Locations

United States, Alabama

University of Alabama at Birmingham Cancer Center; Recruiting

Birmingham, Alabama, United States, 35233

Contact: Site Public Contact 205-934-0220 tmyrick@uab.edu

Principal Investigator: Sravanti Rangaraju

United States, Connecticut

Yale University; Recruiting

New Haven, Connecticut, United States, 06520

Contact: Site Public Contact 203-785-5702 canceranswers@yale.edu

Principal Investigator: Lourdes M. Mendez

United States, Idaho

Saint Luke's Cancer Institute - Boise; Recruiting

Boise, Idaho, United States, 83712

Contact: Site Public Contact 208-381-2774 eslinget@slhs.org

Principal Investigator: Alison K. Conlin

United States, Illinois

Northwestern University; Recruiting

Chicago, Illinois, United States, 60611

Contact: Site Public Contact 312-695-1301 cancer@northwestern.edu

Principal Investigator: Shira N. Dinner

NorthShore University HealthSystem-Evanston Hospital; Recruiting

Evanston, Illinois, United States, 60201

Contact: Site Public Contact 847-570-2109

Principal Investigator: Amy Y. Wang

NorthShore University HealthSystem-Glenbrook Hospital; Recruiting

Glenview, Illinois, United States, 60026

Contact: Site Public Contact 847-570-2109

Principal Investigator: Amy Y. Wang

NorthShore University HealthSystem-Highland Park Hospital; Recruiting

Highland Park, Illinois, United States, 60035

Contact: Site Public Contact 847-570-2109

Principal Investigator: Amy Y. Wang

United States, Missouri

Siteman Cancer Center at West County Hospital; Recruiting

Creve Coeur, Missouri, United States, 63141

Contact: Site Public Contact 800-600-3606 info@siteman.wustl.edu

Principal Investigator: Ramzi Abboud

Washington University School of Medicine; Recruiting

Saint Louis, Missouri, United States, 63110

Contact: Site Public Contact 800-600-3606 info@siteman.wustl.edu

Principal Investigator: Ramzi Abboud

Siteman Cancer Center-South County; Recruiting

Saint Louis, Missouri, United States, 63129

Contact: Site Public Contact 800-600-3606 info@siteman.wustl.edu

Principal Investigator: Ramzi Abboud

Siteman Cancer Center at Christian Hospital; Recruiting

Saint Louis, Missouri, United States, 63136

Contact: Site Public Contact 800-600-3606 info@siteman.wustl.edu

Principal Investigator: Ramzi Abboud

Siteman Cancer Center at Saint Peters Hospital; Recruiting

Saint Peters, Missouri, United States, 63376

Contact: Site Public Contact 800-600-3606 info@siteman.wustl.edu

Principal Investigator: Ramzi Abboud

United States, Nebraska

Nebraska Medicine-Bellevue; Recruiting

Bellevue, Nebraska, United States, 68123

Contact: Site Public Contact 402-559-6941 unmcrsa@unmc.edu

Principal Investigator: Vijaya R. Bhatt

Nebraska Medicine-Village Pointe; Recruiting

Omaha, Nebraska, United States, 68118

Contact: Site Public Contact 402-559-5600

Principal Investigator: Vijaya R. Bhatt

University of Nebraska Medical Center; Recruiting

Omaha, Nebraska, United States, 68198

Contact: Site Public Contact 402-559-6941 unmcrsa@unmc.edu

Principal Investigator: Vijaya R. Bhatt

United States, New York

Mount Sinai Hospital; Recruiting

New York, New York, United States, 10029

Contact: Site Public Contact 212-824-7309 CCTO@mssm.edu

Principal Investigator: Jonathan Feld

United States, Ohio

Ohio State University Comprehensive Cancer Center; Recruiting

Columbus, Ohio, United States, 43210

Contact: Site Public Contact 800-293-5066 Jamesline@osumc.edu

Principal Investigator: Kieran D. Sahasrabudhe

United States, Oklahoma

University of Oklahoma Health Sciences Center; Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contact: Site Public Contact 405-271-8777 ou-clinical-trials@ouhsc.edu

Principal Investigator: Mohamad Khawandanah

United States, Oregon

Providence Portland Medical Center; Recruiting

Portland, Oregon, United States, 97213

Contact: Site Public Contact 503-215-2614 CanRsrchStudies@providence.org

Principal Investigator: Alison K. Conlin

Providence Saint Vincent Medical Center; Recruiting

Portland, Oregon, United States, 97225

Contact: Site Public Contact 503-215-2614 CanRsrchStudies@providence.org

Principal Investigator: Alison K. Conlin

United States, Pennsylvania

Thomas Jefferson University Hospital; Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contact: Site Public Contact 215-600-9151 ONCTrialNow@jefferson.edu

Principal Investigator: Gina M. Keiffer

United States, South Carolina

Medical University of South Carolina; Recruiting

Charleston, South Carolina, United States, 29425

Contact: Site Public Contact 843-792-9321 hcc-clinical-trials@musc.edu

Principal Investigator: Alexander Coltoff

United States, Virginia

Virginia Commonwealth University/Massey Cancer Center; Not yet recruiting

Richmond, Virginia, United States, 23298

Contact: Site Public Contact CTOclinops@vcu.edu

Principal Investigator: Keri R. Maher

United States, Wisconsin

Gundersen Lutheran Medical Center; Recruiting

La Crosse, Wisconsin, United States, 54601

Contact: Site Public Contact 608-775-2385 cancerctr@gundersenhealth.org

Principal Investigator: Michael O. Ojelabi

Medical College of Wisconsin; Recruiting

Milwaukee, Wisconsin, United States, 53226

Contact: Site Public Contact 414-805-3666

Principal Investigator: Guru Subramanian Guru Murthy

Sponsors and Collaborators

Alliance for Clinical Trials in Oncology

National Cancer Institute (NCI)

Investigators

• Study Chair: Marlise R. Luskin, MD, MSCE; Dana-Farber Cancer Institute

More Information

• Responsible Party: Alliance for Clinical Trials in Oncology
• ClinicalTrials.gov Identifier: NCT05303792
• Other Study ID Numbers: A042001; NCI-2022-01735 ( Registry Identifier: NCI Clinical Trial Reporting Program ); U10CA180821 ( U.S. NIH Grant/Contract )
• First Posted: March 31, 2022
• Last Update Posted: November 1, 2023
• Last Verified: October 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Lymphoma; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Cytarabine; Dexamethasone; Prednisone; Methylprednisolone; Cyclophosphamide; Rituximab; Doxorubicin; Methotrexate; Vincristine; Mercaptopurine; Inotuzumab Ozogamicin; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents