CI

At a glance

ClinicalIndex Comparison Record
Phase 2Terminated· 4 enrolled
Drug / intervention
Cyclophosphamide +12 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03488225
NCT03488225Phase 2Terminated
Terminated

Phase II Study of the Hyper-CVAD Regimen in Sequential Combination With Inotuzumab Ozogamicin as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia

M.D. Anderson Cancer Center·interventional·Posted Apr 4, 2018·Updated Jul 16, 2024

In Brief

A Phase 2 clinical trial evaluating Cyclophosphamide, Cytarabine, and 11 other interventions for Acute Lymphoblastic Leukemia in Remission and 2 related conditions. Terminated early, enrolled 4 participants across 1 site.

Signals

Trial was terminated early

Detailed Summary

This phase II trial studies how well combination chemotherapy and inotuzumab ozogamicin work in treating patients with B acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, methotrexate and cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as inotuzumab ozogamicin, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy and inotuzumab ozogamicin may work better at treating B acute lymphoblastic leukemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2TerminatedFinished
20192020202120222023202420252026
First PostedApr 4, 2018
Enrollment StartMar 28, 2018
Primary CompletionApr 2, 2020
TodayJul 1, 2026
Enrollment to primary: 2.0 yearsPosted 8.2 years ago

Interventions

Cyclophosphamidedrug

Given IV

Cytarabinedrug

Given IT or IV

Dexamethasonedrug

Given IV or PO

Doxorubicin Hydrochloridedrug

Given IV

Inotuzumab Ozogamicinbiological

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Leucovorin Calciumdrug

Given IV

Mercaptopurinedrug

Given PO

Methotrexatedrug

Given IT, IV or PO

Ofatumumabbiological

Given IV

Prednisonedrug

Given PO

Rituximabbiological

Given IV

Vincristine Sulfatedrug

Given IV