NCT00387959

Brief Summary

RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine, total-body irradiation, and rituximab before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving chemotherapy and radiation therapy together with rituximab and an umbilical cord blood transplant works in treating patients with B-cell non-Hodgkin's lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_2 leukemia

Timeline
Completed

Started Jul 2006

Typical duration for phase_2 leukemia

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

July 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2006

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

February 1, 2016

Completed
Last Updated

February 1, 2016

Status Verified

December 1, 2015

Enrollment Period

7.8 years

First QC Date

October 12, 2006

Results QC Date

December 22, 2015

Last Update Submit

December 22, 2015

Conditions

LeukemiaLymphoma

Keywords

recurrent mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent adult diffuse large cell lymphomastage III adult diffuse large cell lymphomastage IV adult diffuse large cell lymphomaB-cell chronic lymphocytic leukemiarefractory chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomarecurrent marginal zone lymphomarecurrent adult diffuse small cleaved cell lymphomasplenic marginal zone lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomanoncontiguous stage II marginal zone lymphomastage III marginal zone lymphomastage IV marginal zone lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomastage III adult diffuse small cleaved cell lymphomastage IV adult diffuse small cleaved cell lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II mantle cell lymphoma

Outcome Measures

Primary Outcomes (1)

  • Survival at 1 Year After Transplantation

    The number of patients survival status 1 year after transplantation

    1 Year after transplant

Study Arms (1)

Unrelated Donor Umbilical Cord Transplant

EXPERIMENTAL

Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood

Biological: filgrastimBiological: rituximabDrug: cyclophosphamideDrug: cyclosporineDrug: fludarabine phosphateDrug: mycophenolate mofetilProcedure: allogeneic hematopoietic stem cell transplantationProcedure: umbilical cord blood transplantationRadiation: total-body irradiation

Interventions

filgrastimBIOLOGICAL
Unrelated Donor Umbilical Cord Transplant
rituximabBIOLOGICAL
Unrelated Donor Umbilical Cord Transplant
cyclophosphamideDRUG
Unrelated Donor Umbilical Cord Transplant
cyclosporineDRUG
Unrelated Donor Umbilical Cord Transplant
fludarabine phosphateDRUG
Unrelated Donor Umbilical Cord Transplant
mycophenolate mofetilDRUG
Unrelated Donor Umbilical Cord Transplant
allogeneic hematopoietic stem cell transplantationPROCEDURE
Unrelated Donor Umbilical Cord Transplant
umbilical cord blood transplantationPROCEDURE
Unrelated Donor Umbilical Cord Transplant
total-body irradiationRADIATION
Unrelated Donor Umbilical Cord Transplant

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * CD20+\* aggressive B-cell non-Hodgkin's lymphoma (NHL), including 1 of the following: * Diffuse large cell (DLC) NHL meeting 1 of the following criteria: * Relapsed disease after initial therapy but failed to mobilize or had bone marrow involvement and therefore is not suitable for an autologous stem cell transplantation * High-intermediate or high-risk, second-line, age-adjusted International Prognostic Index (IPI) score and in second complete remission (CR) or partial remission (PR) after prior autologous stem cell transplantation * Failed prior autologous stem cell transplantation and in at least PR after salvage chemotherapy * Large cell transformation of indolent NHL/chronic lymphocytic leukemia (CLL) meeting the following criteria: * CR/PR of the large cell component of disease after salvage chemotherapy or autologous stem cell transplantation * Mantle cell lymphoma meeting 1 of the following criteria: * High-risk, as defined by p53 positivity and in first CR/PR after initial therapy * Relapsed disease after initial therapy and in second or third CR/PR after salvage chemotherapy * CD20+\* indolent NHL or CLL meeting the following criteria: * Must be in second or subsequent progression (pre-allograft cytoreduction necessary but CR/PR not required) * Indolent NHL includes, but is not limited to, any of the following: * Follicular NHL * Small cell NHL * Marginal zone NHL NOTE: \*CD20 positivity must be demonstrated within the past 12 months * Relapsed disease must be biopsy proven * Prior pre-allograft cytoreduction may have included 1 of the following: * Single autologous stem cell transplantation with high-dose chemotherapy conditioning, if appropriate, and no conditioning prior to transplantation * Two or more courses of intensive combination chemotherapy (e.g., rituximab, irinotecan hydrochloride, cetuximab, epirubicin hydrochloride \[RICE\]) as appropriate according to diagnosis and prior therapy * Heavily pre-treated CLL patients in whom further combination chemotherapy is not appropriate may receive single-agent intermediate-dose cyclophosphamide for 2-3 courses * No mantle cell or DLC NHL with progressive disease at allograft work-up * No suitable matched related or unrelated donor available * Two umbilical cord blood (UCB) units available meeting the following criteria: * Units and recipient must be ≥ 4/6 HLA-A and -B antigen and DRB1 allele matched * Each unit must have ≥ 1.5 x 10\^7 total nucleated cells/recipient body weight PATIENT CHARACTERISTICS: * Karnofsky performance score 70-100% * Creatinine clearance ≥ 50 mL/min * Bilirubin \< 2.5 mg/dL * AST and ALT ≤ 3 times upper limit of normal (unless due to benign congenital hyperbilirubinemia) * Spirometry and corrected DLCO ≥ 50% normal * LVEF ≥ 40% * Albumin ≥ 2.5 g/dL * No active and uncontrolled infection at time of transplantation, including active infection with Aspergillus or other mold * No HIV positivity * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No more than 120 days since prior autologous stem cell transplantation * No more than 60 days since prior chemotherapy * No prior allogeneic transplantation

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

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaLymphoma, Mantle-CellLymphoma, Large B-Cell, DiffuseLeukemia, Lymphocytic, Chronic, B-CellLymphoma, B-Cell, Marginal ZoneLymphoma, Non-HodgkinLymphoma, Follicular

Interventions

FilgrastimRituximabCyclophosphamideCyclosporinefludarabine phosphateMycophenolic AcidCord Blood Stem Cell TransplantationWhole-Body Irradiation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsSerum GlobulinsGlobulinsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipidsStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, OperativeRadiotherapyInvestigative Techniques

Results Point of Contact

Title
Dr. Juliet Barker
Organization
Memorial Sloan Kettering Cancer Center
barkerj@mskcc.org
212-639-3468

Study Officials

  • Juliet Barker, MBBS

    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

October 12, 2006

First Posted

October 13, 2006

Study Start

July 1, 2006

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

February 1, 2016

Results First Posted

February 1, 2016

Record last verified: 2015-12

Locations

US(1)