NCT00720447

Brief Summary

RATIONALE: Giving chemotherapy and monoclonal antibody therapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. PURPOSE: This phase II trial is studying donor stem cell transplant in treating patients with mantle cell lymphoma.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_2 lymphoma

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 22, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Last Updated

August 2, 2013

Status Verified

July 1, 2011

Enrollment Period

2 years

First QC Date

July 19, 2008

Last Update Submit

August 1, 2013

Conditions

Lymphoma

Keywords

stage III mantle cell lymphomastage IV mantle cell lymphoma

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

Secondary Outcomes (2)

  • Overall survival

  • Toxicity

Interventions

alemtuzumabBIOLOGICAL
donor lymphocytesBIOLOGICAL
carmustineDRUG
cytarabineDRUG
etoposideDRUG
melphalanDRUG
allogeneic bone marrow transplantationPROCEDURE
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of mantle cell lymphoma * No relapsed or progressive disease * Achieved at least a partial remission following induction chemotherapy * HLA-matched donor available * Blood samples from both patient and donor available for chimerism studies * No central nervous system involvement PATIENT CHARACTERISTICS: * ECOG performance status 2-4 * Considered fit for transplant by treating physician * Serum bilirubin ≤ 1.5 times upper limit of normal * Alkaline phosphatase ≤ 2 times normal * Creatinine clearance ≥ 50 mL/min * Ejection fraction \> 50% (no inadequate cardiac function) * Not pregnant or nursing * Negative pregnancy test * No symptomatic respiratory compromise * No serious concurrent disease which would preclude allograft * No known serological positivity for hepatitis B, hepatitis C, or HIV * No history of a psychological illness or condition that would affect compliance * No previous malignancy within the past 5 years except nonmelanoma skin tumors or stage 0 (in situ) cervical carcinoma PRIOR CONCURRENT THERAPY: * See Disease Characteristics

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

Sponsors & Collaborators

MeSH Terms

Conditions

LymphomaLymphoma, Mantle-Cell

Interventions

AlemtuzumabCarmustineCytarabineEtoposideMelphalanPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsNitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Simon Rule, MD

    Derriford Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 19, 2008

First Posted

July 22, 2008

Study Start

November 1, 2008

Primary Completion

November 1, 2010

Last Updated

August 2, 2013

Record last verified: 2011-07