NCT00238433

Brief Summary

RATIONALE: Chemotherapy, such as busulfan, melphalan, and thiotepa, may destroy cancerous blood-forming cells (stem cells) in the blood and bone marrow. Giving the patient their healthy stem cells will help their bone marrow make new stem cells that become red blood cells, white blood cells, and platelets. PURPOSE: This phase II trial is studying how well busulfan, melphalan, and thiotepa work in treating patients who are undergoing an autologous stem cell transplant for Hodgkin's or non-Hodgkin's lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for phase_2 lymphoma

Timeline
Completed

Started Mar 2005

Longer than P75 for phase_2 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

March 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2005

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
5 months until next milestone

Results Posted

Study results publicly available

May 11, 2017

Completed
Last Updated

September 27, 2017

Status Verified

September 1, 2017

Enrollment Period

10.4 years

First QC Date

October 12, 2005

Results QC Date

March 31, 2017

Last Update Submit

September 25, 2017

Conditions

Lymphoma

Keywords

recurrent adult Hodgkin lymphomarecurrent adult diffuse small cleaved cell lymphomastage III adult diffuse small cleaved cell lymphomastage IV adult diffuse small cleaved cell lymphomarecurrent grade 3 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 3 follicular lymphomarecurrent adult diffuse mixed cell lymphomastage III adult diffuse mixed cell lymphomastage IV adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomastage III adult diffuse large cell lymphomastage IV adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomastage III adult immunoblastic large cell lymphomastage IV adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomastage III adult lymphoblastic lymphomastage IV adult lymphoblastic lymphomarecurrent adult Burkitt lymphomastage III adult Burkitt lymphomastage IV adult Burkitt lymphomarecurrent mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomarecurrent marginal zone lymphomasplenic marginal zone lymphomarecurrent small lymphocytic lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent/refractory childhood Hodgkin lymphomastage III childhood Hodgkin lymphomastage IV childhood Hodgkin lymphomarecurrent childhood anaplastic large cell lymphomastage III childhood anaplastic large cell lymphomastage IV childhood anaplastic large cell lymphomachildhood grade III lymphomatoid granulomatosisrecurrent childhood large cell lymphomastage III childhood large cell lymphomastage IV childhood large cell lymphomarecurrent childhood lymphoblastic lymphomastage III childhood lymphoblastic lymphomastage IV childhood lymphoblastic lymphomarecurrent childhood small noncleaved cell lymphomastage III childhood small noncleaved cell lymphomastage IV childhood small noncleaved cell lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphoma

Outcome Measures

Primary Outcomes (2)

  • Disease-Free Survival

    The data presented below represents the total number of subjects (out of 36) that reached disease-free survival status during Months 3, 6, 9, 12, 18, and 24 time points.

    3, 6, 9, 12, 18, and 24 months post transplantation

  • Therapy-Related Toxicities

    The table presented below reflects how many participants (out of 36 total) presented an adverse event related to the treatment regimen within each toxicity category. To review specific adverse events, both related and unrelated to study treatment, please refer to Adverse Events Section.

    Through 24 months post transplantation

Study Arms (1)

Filgrastim/Melphalan/Thiotepa

EXPERIMENTAL

Biological/Vaccine: filgrastim 5mcg/kg intravenous piggyback (IVPB) will be administered beginning on day +5 and continued until absolute neutrophil count (ANC) \> 1500 for 2 consecutive days. Drug: busulfan 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours. Drug: melphalan 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml. Drug: thiotepa 250 mg/m2/day/iv on days -3 and -2 Procedure/Surgery: bone marrow ablation with stem cell support The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy. Procedure/Surgery: peripheral blood stem cell transplantation Performed 36-48 hours following last chemotherapy dose.

Biological: filgrastimDrug: busulfanDrug: melphalanDrug: thiotepaProcedure: bone marrow ablation with stem cell supportProcedure: peripheral blood stem cell transplantation

Interventions

filgrastimBIOLOGICAL

5mcg/kg IVPB will be administered beginning on day +5 and continued until ANC\> 1500 for 2 consecutive days.

Filgrastim/Melphalan/Thiotepa
busulfanDRUG

3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.

Filgrastim/Melphalan/Thiotepa
melphalanDRUG

50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.

Filgrastim/Melphalan/Thiotepa
thiotepaDRUG

250 mg/m2/day/iv on days -3 and -2

Filgrastim/Melphalan/Thiotepa
bone marrow ablation with stem cell supportPROCEDURE

The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.

Filgrastim/Melphalan/Thiotepa
peripheral blood stem cell transplantationPROCEDURE

Performed 36-48 hours following last chemotherapy dose.

Filgrastim/Melphalan/Thiotepa

Eligibility Criteria

AgeUp to 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Intermediate- or high-grade non-Hodgkin's lymphoma (NHL), meeting 1 of the following criteria: * In first complete remission (CR) AND at high-risk for relapse, as defined by all of the following criteria: * High age-adjusted International Prognostic Index category AND meets the following criteria at diagnosis: * Stage III or IV disease * Lactic dehydrogenase abnormal * Eastern Cooperative Oncology Group (ECOG) score 0-2 * Mantle cell histology * Primary refractory disease * Beyond first CR * Low-grade NHL * Beyond second relapse * Hodgkin's lymphoma * Primary refractory disease OR beyond first CR * Must have an adequate number of stored autologous peripheral blood stem cells (PBSCs) (i.e., 2.0 x 10\^6 hematopoietic progenitor cell antigen (CD34)-positive cells/kg) * Patients who are not able to mobilize a sufficient number of PBSCs may use bone marrow instead * No active CNS disease NOTE: 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 * 0 to 70 Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin \< 2 times upper limit of normal (ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 times ULN Renal * Creatinine ≤ 2.0 mg/dL * Creatinine clearance ≥ 50 mL/min Pulmonary * No significant pulmonary dysfunction, defined as Diffusing Capacity the Lung for Carbon monoxide (DLCO) \< 60% of predicted Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception for ≥ 2 months before and during study participation * HIV negative * No significant active infection that would preclude PBSC transplantation PRIOR CONCURRENT THERAPY: Biologic therapy * No prior transplantation * No other concurrent blood products during PBSC transplantation Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * More than 60 days since prior local or regional radiotherapy Surgery * Not specified Other * More than 30 days since prior investigational drugs * No concurrent amphotericin

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

Sponsors & Collaborators

Study Sites (1)

Knight Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

MeSH Terms

Conditions

LymphomaHodgkin DiseaseLymphoma, Non-HodgkinLymphoma, FollicularLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellRecurrenceLymphoma, Large-Cell, AnaplasticDendritic Cell Sarcoma, InterdigitatingLymphoma, T-Cell, Cutaneous

Interventions

FilgrastimBusulfanMelphalanThiotepaPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, T-CellHistiocytic Disorders, MalignantHistiocytosis

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsButylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsPhosphoramidesOrganophosphorus CompoundsTriethylenephosphoramideAziridinesAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Results Point of Contact

Title
Richard Maziarz, MD
Organization
Oregon Health & Science University
maziarzr@ohsu.edu
503-494-6365

Study Officials

  • Richard Maziarz, MD

    OHSU Knight Cancer Institute

    STUDY CHAIR

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
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 12, 2005

First Posted

October 13, 2005

Study Start

March 1, 2005

Primary Completion

August 1, 2015

Study Completion

December 1, 2016

Last Updated

September 27, 2017

Results First Posted

May 11, 2017

Record last verified: 2017-09

Locations

US(1)