NCT00003402

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus combination chemotherapy in treating patients who have low-grade non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for phase_2 leukemia

Timeline
Completed

Started Jan 1999

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

January 1, 1999

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

March 31, 2004

Completed
Last Updated

October 17, 2019

Status Verified

October 1, 2019

Enrollment Period

3.9 years

First QC Date

November 1, 1999

Last Update Submit

October 15, 2019

Conditions

LeukemiaLymphoma

Keywords

Waldenstrom macroglobulinemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarefractory chronic lymphocytic leukemiastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphoma

Interventions

carmustineDRUG
cisplatinDRUG
cyclophosphamideDRUG
dexamethasoneDRUG
etoposideDRUG
melphalanDRUG
paclitaxelDRUG
bone marrow ablation with stem cell supportPROCEDURE
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed low grade follicular lymphoma, mantle cell lymphoma, or chronic lymphocytic leukemia with no greater than 12 months of prior standard therapy Follicular lymphoma Must have poor prognosis disease defined as any of the following: Any nodal or extranodal tumor mass with a diameter more than 7 cm Involvement of at least 3 nodal sites, each of which has a diameter greater than 3 cm Systemic symptoms Substantial splenic involvement no greater than 5 cm below left costal margin Serous effusions (ascites, pleural or pericardial effusions) Orbital or epidural involvement Ureteral compression Leukemia presentation (at least 500/microliter) Increased LDH level Greater than 20% bone marrow involvement Mantle cell lymphoma No mantle zone morphology Chronic lymphocytic leukemia Must have either anemia (hemoglobin less than 10 g/dL), thrombocytopenia (less than 100,000/mm3), cytogenetic abnormalities including +12 and 11q, elevated LDH levels, labeling index at least 2%, systemic symptoms, or hepatosplenomegaly No active CNS disease A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: At least 4,000/g CD34+ peripheral blood stem cells available See Disease Characteristics Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 4 times upper limit of normal No active chronic hepatitis or liver cirrhosis Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: Left ventricular ejection fraction at least 50% Pulmonary: FEV1, FVC, and DLCO at least 50% of predicted Other: HIV negative No active infection requiring intravenous antibiotics Not pregnant or nursing Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: Prior corticosteroids allowed Radiotherapy: At least 4 weeks since prior local radiotherapy Surgery: Not specified

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

Sponsors & Collaborators

Study Sites (1)

Marlene & Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaWaldenstrom MacroglobulinemiaLeukemia, Lymphocytic, Chronic, B-CellLymphoma, FollicularLymphoma, Mantle-Cell

Interventions

CarmustineCisplatinCyclophosphamideDexamethasoneEtoposideMelphalanPaclitaxelPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Nitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicGlucosidesGlycosidesCarbohydratesPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Barry R. Meisenberg, MD

    University of Maryland Greenebaum Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

March 31, 2004

Study Start

January 1, 1999

Primary Completion

December 1, 2002

Study Completion

December 1, 2002

Last Updated

October 17, 2019

Record last verified: 2019-10

Locations

US(1)