Rituxan + BEAM and Auto Stem Cell Transplant for High Risk Lymphoma or Hodgkin's Disease

NCT01702961 | Completed Results DMC

• 2 other identifiers: H-11892Rituxan+BEAM
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief Summary

High-dose chemotherapy followed by autologous (the patient's own) peripheral blood (circulating blood) stem cell (cells that divide to form white cells, red cells and cells that help clot) transplantation is a conventional treatment for patients with lymphoma (cancer of lymph glands) and Hodgkin's disease (cancer of lymph glands) after first relapse (recurrence of disease). For patients who did not have a complete response after traditional chemotherapy, the chance is high that the tumor will return even after high-dose chemotherapy. To improve the response and decrease the chance of relapse, doctors have used rituximab, an antibody that kills lymphoma cells, both before and after transplantation. These doctors have reported that more patients had control of the tumor for an extended period of time using rituximab with high-dose chemotherapy with autologous stem cell transplantation. How widely this is applicable is not known. The purpose of this clinical research trial is to confirm that there is a good control of tumor in patients with lymphoma or Hodgkin's disease treated with rituximab and conventional stem cell transplantation.

Conditions

Lymphoma; Hodgkin's Disease

Keywords

Lymphoma; Hodgkin's Disease

Outcome Measures

Primary Outcomes (1)

• Disease-free Survival

  Disease-free survival at 12 months post-transplant in patients with Hodgkin's disease or non-Hodgkin's lymphomas

  12 months post-transplant

Secondary Outcomes (2)

• Median Days to Neutrophil Engraftment

  30 days post-transplant

• Number of Participants With Overall Best Response Achieved After Transplantation

  3 months post-transplant

Study Arms (1)

BEAM+R: Autologous Stem Cell Transplant

OTHER

Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells

Drug: Melphalan; Drug: Ara-C; Drug: VP-16; Drug: BCNU; Drug: Rituxan; Drug: Stem Cells

Interventions

Melphalan DRUG

Given on Day -1 Melphalan is administered according to the current SOP.

Also known as: Alkeran

BEAM+R: Autologous Stem Cell Transplant

Ara-C DRUG

200 mg/m2 IB BID given on Days -5, -4, -3, -2

Also known as: Cytarabine, Cytosar-u

BEAM+R: Autologous Stem Cell Transplant

VP-16 DRUG

200 mg/m2 IV BID given on Days -5, -4, -3, -2

Also known as: Etoposide

BEAM+R: Autologous Stem Cell Transplant

BCNU DRUG

BCNU 300 mg/m2 IV given on Day -6

Also known as: Carmustine

BEAM+R: Autologous Stem Cell Transplant

Rituxan DRUG

375 mg/m2 IB given on Days -6, +14, +21, +28

Also known as: Rituxamib

BEAM+R: Autologous Stem Cell Transplant

Stem Cells DRUG

Stem cells given on Day 0

Also known as: Autologous Blood Stem Cells

BEAM+R: Autologous Stem Cell Transplant

Eligibility Criteria

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

You may qualify if:

• Patients with biopsy-proven, relapsed, or refractory CD20+ lymphoma, or HD.
• At least 2e6 CD34+/kg autologous PBSC stored. If patients are non-mobilizers, then at least 2e8 TNC/kg autologous marrow should be stored.
• Patient is not pregnant.
• Zubrod performance status less than or equal to 2.
• Life expectancy is not severely limited by concomitant illness.
• Left ventricular ejection fraction greater than or equal to 50%.
• No uncontrolled arrhythmias or symptomatic cardiac disease.
• FEV1, FVC and DLCO greater than or equal to 50%.
• No symptomatic pulmonary disease.
• Serum creatinine less than or equal to 1.5 mg/dL.
• Serum bilirubin less than or equal to 2X upper limit of normal, SGPT less than or equal to 3X upper limit of normal.
• No evidence of chronic active hepatitis or cirrhosis.
• No effusion or ascites greater than or equal to 1L prior to drainage.
• HIV negative.
• Patient or guardian able to sign informed consent.

You may not qualify if:

• Anyone not meeting the above criteria.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• The Methodist Hospital Research Institute: collaborator
• Center for Cell and Gene Therapy, Baylor College of Medicine: collaborator

Study Sites (2)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

Melphalan; Cytarabine; Etoposide; Carmustine; 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)

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

Results Point of Contact

• Title: George Carrum, MD
• Organization: Baylor College of Medicine

GCarrum@houstonmethodist.org

Study Officials

• George Carrum, MD

  Associate Professor; Director-Adult Outpatient Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor; Director-Adult Outpatient Clinic

Study Record Dates

• First Submitted: October 5, 2012
• First Posted: October 10, 2012
• Study Start: June 1, 2002
• Primary Completion: August 1, 2014
• Study Completion: January 1, 2017
• Last Updated: December 19, 2018
• Results First Posted: September 28, 2015

Record last verified: 2018-11

Locations

US (2)