Clinical trial NCT00878254: Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated Mantle Cell Lymphoma
Official title: Phase II Study of Rituximab in Combination With Methotrexate, Doxorubicin, Cyclophosphamide, Leucovorin, Vincristine, Ifosfamide, Etoposide, Cytarabine and Mesna (R-MACLO/VAM) in Patients With Previously Untreated Mantle Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Mantle-Cell Lymphoma
Keywords: Non-Hodgkin's Lymphoma
MCL
NHL
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2009-04-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

1. Previously untreated, histologically confirmed mantle cell lymphoma,
2. Measurable or evaluable disease (at least one site with \>1.5 cm in diameter
3. All stages are eligible
4. Age \> 18 years
5. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
6. 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
7. Serum creatinine\< 1.5 mg/dl
8. Ability to give informed consent
9. 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.
10. Life expectancy greater than 6 months.

Exclusion Criteria:

1. Previous chemotherapy, immunotherapy or radiotherapy for this mantle cell lymphoma
2. Concurrent active malignancies, with the exception of in situ carcinoma of the cervix and basal cell carcinoma of the skin.
3. Grade 3 or 4 cardiac failure and/or ejection fraction \< 50.
4. Psychological, familial, sociological or geographical conditions that do not permit treatment and/or medical follow-up required to comply with the study protocol.
5. Patients with a known history of human immunodeficiency virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS).
6. Presence of hepatitis or hepatitis B virus (HBV) infection.
7. Pregnant or breast-feeding women.
8. Central Nervous System (CNS) involvement.

Primary outcomes:
measure: Rate of Progression-Free Survival (PFS)
timeFrame: Up to 8 years
Secondary outcomes:
measure: Rate of Overall Survival (OS)
timeFrame: Up to 8 years
measure: Rate of Response to Protocol Therapy
timeFrame: Up to 8 years
measure: Rate of Treatment-Related Toxicity in Study Participants
timeFrame: Up to 8 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Izidore S. Lossos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alderuccio JP, Saul EE, Iyer SG, Reis IM, Alencar AJ, Rosenblatt JD, Lossos IS. R-MACLO-IVAM regimen followed by maintenance therapy induces durable remissions in untreated mantle cell lymphoma - Long term follow up results. Am J Hematol. 2021 Jun 1;96(6):680-689. doi: 10.1002/ajh.26163. Epub 2021 Apr 7.