GM-CSF and Rituximab After Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Follicular Non-Hodgkin Lymphoma

NCT00521014 | Completed Phase 2 Results

• 4 other identifiers: 07-085P30CA008748MSKCC-07085BRLX-MSKCC-07-085
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Giving high-dose chemotherapy before an autologous stem cell transplant helps stop the growth of cancer cells by stopping them from dividing or by killing them. An autologous stem cell transplant may be able to replace the blood-forming cells that were destroyed by chemotherapy. GM-CSF may increase the number of immune cells found in bone marrow or peripheral blood. Giving a monoclonal antibody, such as rituximab, after the transplant may find any remaining cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Giving GM-CSF together with rituximab after autologous stem cell transplant may be an effective treatment for follicular non-Hodgkin lymphoma. PURPOSE: This phase II trial is studying how well giving GM-CSF together with rituximab after autologous stem cell transplant works in treating patients with relapsed or primary refractory follicular non-Hodgkin lymphoma.

Conditions

Lymphoma

Keywords

recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival Rate

  after autologous stem cell transplantation (ASCT). Disease progression is defined using International Workshop Criteria for non-Hodgkin lymphoma37 and is defined as: 1. ≥ 50% increase in products of diameters of any previously identified abnormal node or nodule AND/OR 2. appearance of any new lesions

  up to 3 years

Study Arms (1)

GM-CSF and Rituximab After Autologous Stem Cell Transplant

EXPERIMENTAL

GM-CSF: 250 mcg (flat dose) three times per week for 8 weeks, administered on alternate days. Thus, 24 doses of GM-CSF will be administered. Rituximab: 375 mg/m2/week for 4 weeks, beginning within 3 days after the first dose of GM-CSF; rituximab. The second course of GM-CSF and rituximab will be administered approximately 22-26 weeks (day +154 to +182) after ASCT.

Biological: filgrastim; Biological: rituximab; Biological: sargramostim; Drug: carmustine; Drug: cytarabine; Drug: etoposide; Drug: melphalan; Procedure: autologous hematopoietic stem cell transplantation

Interventions

filgrastim BIOLOGICAL

GM-CSF and Rituximab After Autologous Stem Cell Transplant

rituximab BIOLOGICAL

GM-CSF and Rituximab After Autologous Stem Cell Transplant

sargramostim BIOLOGICAL

GM-CSF and Rituximab After Autologous Stem Cell Transplant

carmustine DRUG

GM-CSF and Rituximab After Autologous Stem Cell Transplant

cytarabine DRUG

GM-CSF and Rituximab After Autologous Stem Cell Transplant

etoposide DRUG

GM-CSF and Rituximab After Autologous Stem Cell Transplant

melphalan DRUG

GM-CSF and Rituximab After Autologous Stem Cell Transplant

autologous hematopoietic stem cell transplantation PROCEDURE

GM-CSF and Rituximab After Autologous Stem Cell Transplant

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologic diagnosis of grade 1, 2, 3, or transformed follicular lymphoma * Achieved a complete or partial response to last salvage therapy * Completed salvage therapy within the past 12 weeks * No disease progression since last salvage therapy * One of the following disease statuses must have been present prior to receiving salvage therapy * Refractory to last anti-lymphoma therapy * Last remission duration less than 1½ years if salvage therapy is 3rd regimen * Last remission duration less than 3 years if salvage therapy is 2nd regimen * Minimum of 2 x 10\^6 CD34+ cells/kg cryopreserved and available for hematopoietic stem cell support * No leptomeningeal disease or brain parenchyma involvement PATIENT CHARACTERISTICS: * Cardiac ejection fraction \> 50% * If over 60 years of age, no evidence of cardiac ischemia by treadmill stress test (stress echo or sesta-MIBI) * Adjusted diffusing capacity ≥ 50% of the predicted value on pulmonary function testing * Creatinine ≤ 1.5 mg/dL OR creatinine clearance \> 50 mL/min * ANC \> 1,000/μL * Platelet count \> 50,000/μL * Total bilirubin ≤ 2.0 mg/dL (≤ 3.0 mg/dL if Gilbert's disease is suspected) * Not pregnant or breast-feeding * Fertile patients must use an acceptable form of birth control * HIV I or II negative * No acute or chronic hepatitis B * No active hepatitis C * No medical illness (unrelated to non-Hodgkin lymphoma), including malignancies that, in the opinion of the attending physician and/or principal investigator, would preclude study treatment * No other malignancy within the past 5 years except curatively treated cutaneous basal cell or squamous cell carcinoma or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: * No more than 3 prior anti-lymphoma regimens, inclusive of the salvage therapy * Biologic agents (e.g., monoclonal antibodies and vaccines) administered as part of a planned treatment regimen will not be considered distinct regimens * Chemotherapy administered primarily for the purpose of stem cell mobilization (e.g., cyclophosphamide at 2-4 g/m²) will not be considered an anti-lymphoma regimen * No prior autologous or allogeneic hematopoietic stem cell transplantation

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular

Interventions

Filgrastim; Rituximab; sargramostim; Carmustine; Cytarabine; Etoposide; Melphalan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; 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; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids

Results Point of Contact

• Title: Dr. Craig Moskowitz
• Organization: Memorial Sloan Kettering Cancer Center

moskowic@mskcc.org

212-639-7992

Study Officials

• Craig Moskowitz, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Matthew Matasar, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: August 24, 2007
• First Posted: August 27, 2007
• Study Start: October 1, 2007
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 22, 2015
• Results First Posted: December 22, 2015

Record last verified: 2015-11

Locations

US (1)