Rituximab in Addition to Autologous Transplantation With BEAM for Patients With Lymphoid Malignancies

NCT00472056 | Completed Phase 2 Results DMC

• 1 other identifier: 2004-0271
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

Cohort 1: Patients who are less than or equal to 65 years of age. 1\. To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high dose rituximab) Cohort 2: Patients who are older than 65 years of age

1. 1.To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high dose rituximab)
2. 2.To determine the treatment related mortality (TRM)

Conditions

Lymphoma

Keywords

Non-Hodgkin's Lymphoma; Lymphoid Malignancies; Lymphoma; BEAM Chemotherapy; Carmustine; BCNU; BiCNU; Etoposide; VePesid; Cytarabine; Cytosar; DepoCyt; Cytosine arabinosine hydrochloride; Ara-C; Melphalan; Rituximab; Rituxan

Outcome Measures

Primary Outcomes (1)

• Disease-free Survival (DFS)

  DFS defined as time from transplantation to disease relapse, disease progression, death during remission, or last follow-up. Evaluation at 3 months and 6 months after transplantation, then every 6 months for 3 years, and then once a year up to 5 years from the transplant date.

  Up to 5 years from transplant date.

Study Arms (2)

BEAM + Standard Rituximab

EXPERIMENTAL

Arm 1 BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Rituximab with Standard Rituximab for Cohort 1 or 2 Cohort 1 for 65 years of age or younger BEAM: Carmustine 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), and melphalan 140 mg/m2 IV on day -1. Cohort 2 for older than 65 years of age BEAM: Carmustine 300 mg/m2 IV over 1 hour on day -6, cytarabine 100 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), etoposide 100 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), and melphalan 140 mg/m2 IV on day -1. Standard Rituximab: 375 mg/m\^2 IV Days +1, +8 after Stem Cell Infusion on Day 0.

Drug: Carmustine; Drug: Etoposide; Drug: Cytarabine; Drug: Melphalan; Drug: Rituximab

BEAM + High Rituximab

EXPERIMENTAL

BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab Cohort 1 for 65 years of age or younger BEAM: Carmustine 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), and melphalan 140 mg/m2 IV on day -1. Cohort 2 for older than 65 years of age BEAM: Carmustine 300 mg/m2 IV over 1 hour on day -6, cytarabine 100 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), etoposide 100 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), and melphalan 140 mg/m2 IV on day -1. High Dose Rituximab: 1000 mg/m\^2 IV Days +1, +8 after Stem Cell Infusion on Day 0

Drug: Carmustine; Drug: Etoposide; Drug: Cytarabine; Drug: Melphalan; Drug: Rituximab

Interventions

Carmustine DRUG

300 mg/m\^2 IV for 1 Day

Also known as: BCNU, BiCNU

BEAM + High Rituximab; BEAM + Standard Rituximab

Etoposide DRUG

Arm 1 = 200 mg/m\^2 IV Every 12 Hours x 4 Days; Arm 2 = 100 mg/m\^2 IV Every 12 Hours x 4 Days

Also known as: VePesid

BEAM + High Rituximab; BEAM + Standard Rituximab

Cytarabine DRUG

Arm 1 = 200 mg/m\^2 IV Every 12 Hours x 4 Days; Arm 2 = 100 mg/m\^2 IV Every 12 Hours x 4 Days

Also known as: Ara-C, Cytosar, DepoCyt, Cytosine arabinosine hydrochloride

BEAM + High Rituximab; BEAM + Standard Rituximab

Melphalan DRUG

140 mg/m\^2 IV x 1 Day

BEAM + High Rituximab; BEAM + Standard Rituximab

Rituximab DRUG

Cohort 1, High-Dose Rituximab = 1000 mg/m\^2 IV On Days +1 and +8 After Stem Cell Infusion; Cohort 2, Standard Dose Rituximab = 375 mg/m\^2 IV On Days +1 and +8 After Stem Cell Infusion.

Also known as: Rituxan

BEAM + High Rituximab; BEAM + Standard Rituximab

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically proven diffuse large B-cell (CD20 positive) or transformed follicular non-Hodgkin's lymphomas, that have relapsed after conventional chemotherapy and are not eligible for protocols of higher priority
• Patients must have chemosensitive disease to salvage chemotherapy and less than 5% bone marrow involvement with lymphoma by gross pathologic examination
• Age less than or equal to 80 years. There is no lower age limit for this study.
• Zubrod performance status of less than 2
• Negative pregnancy test in patients with child bearing potential
• Must be willing to sign informed consent
• Should be seronegative for HIV, hepatitis B surface antigen, hepatitis C antibody.

You may not qualify if:

• Patients with known active CNS disease are excluded. Patients with prior history of CNS disease should have a negative MRI of the brain (and/or spine if indicated) and negative CSF cytology within 4 weeks of enrollment into the study.
• Less than 3 weeks from last cytotoxic chemotherapy
• Serum bilirubin \> 1.5 mg/dl
• Serum transaminases \> 2X/ULN
• Serum creatinine \> 1.6 mg/dl
• Failure to collect more than 3 x 1,000,000 CD34+ stem cells/kg body weight
• Left ventricular ejection fraction of \< 40%, unless cleared by cardiology
• Corrected DLCO of \< 50%
• Patients who are on anticoagulants or antiplatelet agents.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Lymphoma; Lymphoma, Non-Hodgkin

Interventions

Carmustine; Etoposide; Cytarabine; Melphalan; Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Chitra M. Hosing, MD / Associate Professor
• Organization: UT MD Anderson Cancer Center

mvpacheco@mdanderson.org

Study Officials

• Chitra M. Hosing, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2007
• First Posted: May 11, 2007
• Study Start: March 1, 2005
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 15, 2016
• Results First Posted: February 13, 2012

Record last verified: 2012-06

Locations

US (1)