NCT05303792|Active Not RecruitingPhase 2DMCFDA Drug

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

A Randomized Phase II Study Comparing Inotuzumab Plus Chemotherapy Versus Standard Chemotherapy in Older Adults With Philadelphia-Chromosome-Negative B-Cell Acute Lymphoblastic Leukemia

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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3 other identifiers

A042001NCI-2022-01735U10CA180821

Study Type

interventional

Target

Locations

2 countries

Sites

Timeline

RegisteredMar 2022

StartedJun 2023

CompletionMay 2028

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

25mo left

Started Jun 2023

Longer than P75 for phase_2

Geographic Reach

2 countries

72 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.9 years study duration

Study Progress60%

Jun 2023May 2028

First Submitted

Initial submission to the registry

March 18, 2022

Completed

13 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed

1.2 years until next milestone

Study Start

First participant enrolled

June 9, 2023

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected

1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

3 years

First QC Date

March 18, 2022

Last Update Submit

March 28, 2025

Conditions

B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma

Outcome Measures

Primary Outcomes (1)

Event-free survival
Will be evaluated using the methods of Kaplan-Meier as well as Cox regression models.
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)

Secondary Outcomes (7)

Disease-free survival
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
Overall survival
From randomization to the time of death due to any cause, assessed up to 5 years
Complete remission rate
Up to 5 years
Overall response rate
Up to 5 years
MRD-negativity rate
Up to end of cycle 8 (1 cycle = 28 days)
+2 more secondary outcomes

Study Arms (2)

Arm A (inotuzumab ozogamicin, chemotherapy)

EXPERIMENTAL

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: CyclophosphamideDrug: VincristineDrug: DexamethasoneBiological: Inotuzumab OzogamicinDrug: MethotrexateDrug: CytarabineDrug: MethylprednisoloneBiological: RituximabDrug: PrednisoneDrug: Mercaptopurine

Arm B (chemotherapy)

ACTIVE COMPARATOR

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: CyclophosphamideDrug: VincristineDrug: DexamethasoneDrug: MethotrexateDrug: CytarabineDrug: MethylprednisoloneBiological: RituximabDrug: PrednisoneDrug: MercaptopurineDrug: Doxorubicin