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

Therapuetic Areas:Oncology
Age Range:19 - 72
Start Date:March 25, 2009
End Date:December 2019

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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

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).

This is a phase 2 study of Rituximab in combination with Methotrexate, Doxorubicin,
Cyclophosphamide, Leucovorin, Vincristine, Ifosfamide, Etoposide, Cytarabine and Mesna
(R-MACLO/IVAM) in subjects with previously untreated Mantle Cell Lymphoma (MCL). Treatment
will consist of up to 4 cycles of therapy. Response assessment by CT and PET scans will be
performed post Cycle 2. Once the final cycle of therapy is completed, response evaluation
will be performed based on pre-study CT scans, PET/ Scan/endoscopy or any staging scans that
were positive at baseline. (PI approval required if treating with less than 4 cycles).

Subjects in complete remission will be given Rituximab per institution guidelines, as 4
weekly doses every 6 months for a total of 3 years, or until progression of disease, or if
the subject is unable to tolerate further treatment. Rituximab should begin 6 months from
date of discharge +/- 21 days. Maintenance therapy, premedications can be changed based on
clinical consideration from treating physician. Timelines for giving premedications are given
per institutional guidelines. Subject may be discharged after administration of Rituximab,
once stable.

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.
We found this trial at
Miami, Florida 33124
(305) 284-2211
Principal Investigator: Izidore S Lossos, MD
Phone: 305-243-4785
University of Miami A private research university with more than 15,000 students from around the...
Miami, FL
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