CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 enrolled
Drug / intervention
Cyclophosphamide +7 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/NCT01363128
NCT01363128Phase 2Completed

Phase II Study of the Hyper - CVAD Regimen in Combination With Ofatumumab as Frontline Therapy for Patients With CD-20 Positive Acute Lymphoblastic Leukemia

M.D. Anderson Cancer Center·interventional·Posted Jun 1, 2011·Updated May 3, 2021

In Brief

A Phase 2 clinical trial evaluating Cyclophosphamide, Cytarabine, and 6 other interventions for Acute Lymphoblastic Leukemia and 6 related conditions. Completed, enrolled 72 participants across 1 site.

Detailed Summary

This phase II trial studies how well combination chemotherapy and ofatumumab work in treating patients with acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and dexamethasone, 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. Immunotherapy with ofatumumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy together with ofatumumab may be an effective treatment for acute lymphoblastic leukemia or lymphoblastic lymphoma.

Study Details

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 1, 2011
Enrollment StartJul 12, 2011
Primary CompletionApr 8, 2020
TodayJul 1, 2026
Enrollment to primary: 8.7 yearsPosted 15.1 years ago

Interventions

Cyclophosphamidedrug

Given IV

Cytarabinedrug

Given IV

Dexamethasonedrug

Given IV or PO

Doxorubicin Hydrochloridedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Methotrexatedrug

Given IV

Ofatumumabbiological

Given IV

Vincristine Sulfatedrug

Given IV