CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 37 enrolled
Drug / intervention
Cyclophosphamide +8 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/NCT01527149
NCT01527149Phase 2Completed

Ofatumumab (O) in Combination With Chemotherapy: Hyper-Fractionated Cyclophosphamide, Doxorubicin, Vincristine and Dexamethasone (O-HyperCVAD) Alternating With Ofatumumab High-Dose Cytarabine and Methotrexate (O-MA) for Patients With Newly Diagnosed Mantle Cell Lymphoma

Roswell Park Cancer Institute·interventional·Posted Feb 6, 2012·Updated Feb 7, 2024

In Brief

A Phase 2 clinical trial evaluating Autologous Hematopoietic Stem Cell Transplantation, Cyclophosphamide, and 7 other interventions for Stage I Mantle Cell Lymphoma and 4 related conditions. Completed, enrolled 37 participants across 2 sites.

Detailed Summary

This phase II trial studies how well ofatumumab in combination with cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and dexamethasone alternating with ofatumumab in combination with cytarabine and methotrexate works in treating patients with newly diagnosed mantle cell lymphoma (MCL). Monoclonal antibodies, such as ofatumumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, dexamethasone, cytarabine, and methotrexate, 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 ofatumumab together with alternating regimens of combination chemotherapy may kill more cancer cells.

Study Details

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 6, 2012
Enrollment StartDec 6, 2011
Primary CompletionApr 26, 2018
Study CompletionJan 11, 2024
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 14.4 years ago

Interventions

Autologous Hematopoietic Stem Cell Transplantationprocedure

Undergo autologous HDC-ASCT

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