Rituximab + GM-CSF in Patients With Follicular B-Cell Lymphoma

NCT01939730 | Completed Phase 2

• 1 other identifier: DM98-304
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to see if using the drugs Rituximab (IDEC-C2B8) and Granulocyte-macrophage colony-stimulating factor (GM-CSF) (Leukine) together is better than using rituximab alone to treat follicular B-cell lymphomas. The safety of this treatment will also be studied.

Conditions

Lymphoma

Keywords

Lymphoma; Follicular B-Cell Lymphoma; Rituximab; Rituxan; GM-CSF; Sargramostim; Leukine

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate of Rituximab plus GM-CSF of repeat doses (once weekly times four)

  Response Rate is the number of participants with response compared to total. Response definitions: Complete response (CR) defined as those who achieve a normal state which includes no detectable evidence of disease on x-rays. Complete response "unconfirmed" (CRu) defined on the basis of minimal residual abnormalities on x-ray such as a residual mass \<25% of original measurement with no palpable disease on physical examination. Partial response (PR) defined as 50-75% reduction in the product of palpable tumor diameters of in the tumor volume measurements by radiologic criteria or any palpable disease such as peripheral node(s) \> 1 cm in diameter or palpable abdominal mass with histological evidence of lymphoma cells. Minor response or failure includes \<50% tumor shrinkage, or \> 50% but with tumor regrowth between courses.

  1 month

Study Arms (1)

Rituximab + GM-CSF

EXPERIMENTAL

All patients receive one (1) course of therapy consisting of four (4) doses of rituximab, a single dose 375 mg/m\^2 administered once weekly for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly (tiw) for 8 weeks, starting 1 hour before the first dose of rituximab. In selected cases, the GM-CSF starts 1 week before, or 1 day after, the first rituximab dose.

Drug: Rituximab; Drug: GM-CSF

Interventions

Rituximab DRUG

375 mg/m\^2 by vein once a week for 4 weeks on Days 1, 8, 15, 22.

Also known as: Rituxan

Rituximab + GM-CSF

GM-CSF DRUG

250 mcg subcutaneously 3 times a week for 8 weeks.

Also known as: Sagramostim, Leukine

Rituximab + GM-CSF

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed follicular B-cell lymphoma. This can include relapsed patients, who have had no prior rituximab therapy, or previously untreated patients. Previously untreated patients should be made aware of higher priority protocols such as combination chemo-immunotherapy protocols, but if they decline that, they can be entered on this protocol.
• Males or females, 18 years or older; expected survival of =/\> 4 months; performance status of 0, 1 or 2.
• Demonstrable monoclonal cluster of differentiation antigen 20 (CD20)-positive B-cell population.
• Acceptable hematologic status including:
• i. hemoglobin (Hgb) =/\> 8.0 gm/dL
• ii. White blood count (WBC) =/\> 3.0 x 10\^3/mm\^3(x 10\^9/L)
• iii. Absolute granulocyte count =/\> 1.5 x 10\^3/mm\^3
• iv. Platelet count =/\>75 x 10\^3/mm\^3
• e. Adequate renal function (serum creatinine ≤ 2mg/dl)

You may not qualify if:

• presence of Central Nervous System (CNS) Lymphoma
• chronic lymphocytic leukemia (CLL)
• small lymphocytic lymphoma
• therapy in prior 3 weeks (6 weeks for nitrosourea; 6 months for Bone Marrow Transplantation (BMT))
• patients who received prior rituximab or other anti-CD20 therapy
• serious non-malignant disease, or other malignancy
• active infection
• history of HIV infection
• i pregnancy

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lymphoma

Interventions

Rituximab; Granulocyte-Macrophage Colony-Stimulating Factor; Colony-Stimulating Factors; sargramostim

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors

Study Officials

• Felipe Samaniego, MD, MPH, BS

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

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: September 6, 2013
• First Posted: September 11, 2013
• Study Start: August 1, 1999
• Primary Completion: December 1, 2006
• Study Completion: September 1, 2013
• Last Updated: November 4, 2015

Record last verified: 2015-11

Locations

US (1)