Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated Mantle Cell Lymphoma

University of Miami

Status and phase: Active, not recruiting; Phase 2

Conditions: Mantle-Cell Lymphoma

Treatments: Drug: Rituximab; Drug: Cyclophosphamide; Biological: G-CSF; Drug: Ifosfamide; Drug: Methotrexate; Drug: Leucovorin; Drug: Cytarabine; Drug: Vincristine; Drug: Doxorubicin; Drug: Mesna; Drug: Etoposide

Study type: Interventional

Funder types: Other

Identifiers

NCT00878254

20080803

SCCC-2008043 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

25 participants in 1 patient group

R-MACLO/IVAM

Experimental group

Description:

Four 21-day cycles, followed by Maintenance Therapy as follows: * Cycles 1 and 3: Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Methotrexate, Leucovorin, and G-CSF per study protocol. * Cycles 2 and 4: Rituximab, Cytarabine, Ifosfamide, Mesna, Etoposide, and G-CSF per study protocol. * Maintenance Therapy: Rituximab: For study participants in complete remission. Every 6 months for up to 3 years, per study protocol.

Treatment:

Drug: Mesna

Drug: Etoposide

Drug: Doxorubicin

Drug: Vincristine

Drug: Leucovorin

Drug: Cytarabine

Drug: Methotrexate

Drug: Ifosfamide

Biological: G-CSF

Drug: Cyclophosphamide

Drug: Rituximab