NCT01240525

Brief Summary

RATIONALE: Giving low doses of chemotherapy, such as fludarabine and melphalan, before a donor 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). Giving an infusion of the donor's T cells (donor lymphocyte infusion) that have been treated in the laboratory after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving alemtuzumab before transplant and cyclosporine after transplant, may stop this from happening. PURPOSE: This randomized phase II trial is studying donor lymphocyte infusion after stem cell transplant in preventing cancer relapse or cancer progression in patients with follicular lymphoma, small lymphocytic non-Hodgkin lymphoma, or chronic lymphocytic leukemia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2011

Longer than P75 for phase_2

Geographic Reach
1 country

11 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

November 11, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2010

Completed
12 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

8 years

First QC Date

November 11, 2010

Last Update Submit

February 11, 2019

Conditions

Graft Versus Host DiseaseLeukemiaLymphomaMyelomaMyelodysplastic Syndrome

Keywords

graft versus host diseaserecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent small lymphocytic lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphomaWaldenstrom macroglobulinemiastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarefractory chronic lymphocytic leukemiaNon-Hodgkin's lymphomaHodgkin's lymphomaChronic (Pro-)lymphocytic leukaemiaPlasma cell myelomaAcute myeloid leukaemiaAcute lymphoblastic leukaemiaMyelodysplastic syndromeChronic myelomonocytic leukaemia

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival at 1 year post-transplant

    during the study and end of study

Secondary Outcomes (6)

  • Proportion of patients attaining multi-lineage full donor chimerism in peripheral blood

    End of study

  • Incidence of infection requiring inpatient treatment

    during the study and end of study

  • Rate of reconstitution of T-cell subsets and viral-specific immunity

    End of study

  • Cumulative incidence of non-relapse mortality at 1 year

    End of study

  • Overall survival and non-relapse mortality

    End of study

  • +1 more secondary outcomes

Study Arms (2)

CD4 DLI

OTHER

Patients will receive trial product manipulated CD4 DLI post transplant as trial treatment.

Other: CD4 DLI

No DLI

OTHER

Patients will receive no DLI post transplant as trial treatment.

Other: No DLI

Interventions

CD4 DLIOTHER

Patients will receive CD4 DLI between day 70 to 115 post transplant

CD4 DLI
No DLIOTHER

Patients will not receive DLI as trial treatment

No DLI

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Women who are pregnant or breast-feeding
  • Life expectancy of \<8 weeks
  • Currently taking part in any other interventional clinical research study (involving any IMP, ATMP or cellular therapy)
  • Organ dysfunction: Creatinine \>200μmol/l, Bilirubin \>50μmol/l, or AST/ALT \> 3x ULN
  • Post-transplant
  • Active acute GvHD
  • Prior grade II-IV GvHD
  • Relapse or progressive disease
  • Primary or secondary graft failure
  • Other cellular therapies
  • Requirement for ongoing immunosuppression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Birmingham Heartlands Hospital

Birmingham, United Kingdom

Location

Bristol Royal Hospital for Children

Bristol, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Location

St James's University Hospital

Leeds, United Kingdom

Location

Leicester Royal Infirmary

Leicester, United Kingdom

Location

University College Hospital London (UCLH)

London, United Kingdom

Location

Christie Hospital

Manchester, United Kingdom

Location

Nottingham City Hospital

Nottingham, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, United Kingdom

Location

University Hospitals Southampton

Southampton, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Graft vs Host DiseaseLeukemiaLymphomaNeoplasms, Plasma CellMyelodysplastic SyndromesLymphoma, FollicularLeukemia, Lymphocytic, Chronic, B-CellWaldenstrom MacroglobulinemiaLymphoma, Non-HodgkinHodgkin DiseaseBronchiolitis Obliterans SyndromeLeukemia, ProlymphocyticMultiple MyelomaLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myelomonocytic, Juvenile

Condition Hierarchy (Ancestors)

Immune System DiseasesNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersBone Marrow DiseasesLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesLeukemia, MyeloidMyelodysplastic-Myeloproliferative Diseases

Study Officials

  • Ronjon Chakraverty, Professor

    University College Hospital London; UCL Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2010

First Posted

November 15, 2010

Study Start

November 1, 2011

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

February 12, 2019

Record last verified: 2019-02

Locations

GB(11)