NCT00383994

Brief Summary

The goal of this clinical research study is to find out if giving a boost of natural killer (NK) cells from a donor combined with Rituxan (rituximab), can help to control disease in patients who have already received an allogeneic stem cell transplant. The safety of this treatment will also be studied. Participants have recurrent chronic lymphocytic leukemia (CLL) or lymphoma after non-myeloablative stem cell transplantation. Primary Objectives: 1.0 To determine the safety of Natural Killer (NK) cells and Rituximab + rhu-Granulocyte-macrophage colony-stimulating factor (GMCSF) in patients with persistent or recurrent B-cell lymphoid malignancies after non-myeloablative stem cell transplantation. 2.0 To determine factors associated with response.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1 lymphoma

Timeline
Completed

Started Sep 2006

Longer than P75 for phase_1 lymphoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 2, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2006

Completed
12.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2019

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

12.9 years

First QC Date

October 2, 2006

Last Update Submit

July 29, 2019

Conditions

LymphomaLeukemiaTransplantation, Stem CellLymphoid MalignanciesDisorder Related to Transplantation

Keywords

Chronic Lymphocytic LeukemiaCLLNon-Hodgkin's LymphomaB-Cell LymphomaLymphomagranulocyte-macrophage colony-stimulating factorLeukemiaNK CellsRituximabGM-CSFNon-myeloablative Allogeneic Stem Cell TransplantationStem Cell Transplant

Outcome Measures

Primary Outcomes (1)

  • Dose-limiting toxicities (DLTs) for NK cells infusions after non-myeloablative transplantation for lymphoid malignancies

    Maximum tolerated dose (MTD) is the highest dose with 10 patients treated and 5 or fewer patients with DLT.

    Evaluated for toxicity within 6 weeks of treatment

Study Arms (1)

Immunotherapy with NK Cell, Rituximab + GM-CSF

EXPERIMENTAL

Immunotherapy in Non-myeloablative Allogeneic Stem Cell Transplantation GM-CSF = Granulocyte-Macrophage Colony-Stimulating Factor

Drug: GM-CSFDrug: RituximabBiological: NK Cell Infusion

Interventions

GM-CSFDRUG

250 micrograms subcutaneously 3 times a week for 4 weeks starting a day before the administration of Rituximab.

Also known as: Sargramostim, Leukine
Immunotherapy with NK Cell, Rituximab + GM-CSF
RituximabDRUG

375 mg/m\^2 by vein followed by 1000 mg/m\^2 weekly for 3 weeks for a total of 4 doses.

Also known as: Rituxan
Immunotherapy with NK Cell, Rituximab + GM-CSF
NK Cell InfusionBIOLOGICAL

NK cells will be infused one week after the fourth dose of Rituximab and GM-CSF.

Immunotherapy with NK Cell, Rituximab + GM-CSF

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with previous diagnosis of CD20+ B-cell CLL and non-Hodgkin's lymphoma who have failed standard conventional chemotherapy, and who had persistent disease at 3 months, or progressive disease after non-myeloablative allogeneic transplantation.
  • Donor willingness to donate peripheral blood (same donor of the original transplant).
  • Negative Beta HCG in a woman with child bearing potential defined as not post-menopausal for 12 months or not previous surgical sterilization.

You may not qualify if:

  • Pregnancy or lactation
  • HIV , HTLV-I or hepatitis.
  • Active infection(s) \>/= grade 3.
  • Severe active concomitant medical or psychiatric illness.
  • Concurrent active GVHD requiring tacrolimus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

LymphomaLeukemiaLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Non-HodgkinLymphoma, B-Cell

Interventions

Granulocyte-Macrophage Colony-Stimulating FactorsargramostimRituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHematologic DiseasesLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsSerum GlobulinsGlobulins

Study Officials

  • Issa F. Khouri, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2006

First Posted

October 4, 2006

Study Start

September 1, 2006

Primary Completion

July 22, 2019

Study Completion

July 22, 2019

Last Updated

July 31, 2019

Record last verified: 2019-07

Locations

US(1)