NCT00878254CompletedPhase 2
Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated Mantle Cell Lymphoma
Phase II Study of Rituximab in Combination With Methotrexate, Doxorubicin, Cyclophosphamide, Leucovorin, Vincristine, Ifosfamide, Etoposide, Cytarabine and Mesna (R-MACLO/IVAM) in Patients With Previously Untreated Mantle Cell Lymphoma
Source: ClinicalTrials.gov · Last updated 23 Jul 2025
Brief summary (registry, in English)
The investigator(s) hypothesize that Rituximab together with combination chemotherapy, followed by Rituximab maintenance therapy, will provide better disease control with improved response rates and overall survival in patients with previously untreated Mantle Cell Lymphoma (MCL).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (actual)
- First submitted
- 7 Apr 2009
- Start date
- Mar 2009
- Primary completion date
- Jun 2024
- Lead sponsor
- University of Miami
- Diseases
- Mantle cell lymphoma
- NCT number
- NCT00878254
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 25
- From Mar 2009 to the primary completion date, Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous chemotherapy, immunotherapy or radiotherapy for this mantle cell lymphoma
- Concurrent active malignancies, with the exception of in situ carcinoma of the cervix and basal cell carcinoma of the skin.
Other illness
- Psychological, familial, sociological or geographical conditions that do not permit treatment and/or medical follow-up required to comply with the study protocol.
- Patients with a known history of human immunodeficiency virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS).
- Presence of hepatitis or hepatitis B virus (HBV) infection.
Lab values
- Grade 3 or 4 cardiac failure and/or ejection fraction \< 50.
Other
- Pregnant or breast-feeding women.
- Central Nervous System (CNS) involvement.
Who the study is looking for
- Previously untreated, histologically confirmed mantle cell lymphoma,
- Measurable or evaluable disease (at least one site with \>1.5 cm in diameter
- All stages are eligible
- Age \> 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Adequate hepatic function:
- Bilirubin \< 3 mg/dL
- Transaminases (serum glutamic oxaloacetic transaminase (SGOT) and/or serum glutamate-pyruvate transaminase (SGPT)) \< than 2.5 times the upper limit of normal for the institution, unless due to lymphomatous involvement
- Serum creatinine\< 1.5 mg/dl
- Ability to give informed consent
- Women of childbearing potential must have a negative pregnancy test within 72 hours of entering into the study. Males and females must agree to use adequate birth control if conception is possible during the study. Women must avoid pregnancy and men avoid fathering children while in the study.
- Life expectancy greater than 6 months.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.