NCT01926665

Brief Summary

The goal of this clinical research study is to find the highest tolerable dose of carfilzomib that can be given to patients with lymphoma after a stem cell transplant. The safety of this drug will also be studied. Carfilzomib is designed to block cancer cells from repairing themselves. If the cancer cells cannot repair themselves, this may cause them to die.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_1 lymphoma

Timeline
Completed

Started Jun 2014

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

First Submitted

Initial submission to the registry

August 19, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2013

Completed
10 months until next milestone

Study Start

First participant enrolled

June 17, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2017

Completed
Last Updated

September 19, 2017

Status Verified

September 1, 2017

Enrollment Period

3.3 years

First QC Date

August 19, 2013

Last Update Submit

September 18, 2017

Conditions

Lymphoma

Keywords

Blood And Marrow TransplantationMantle cell lymphomaMCLT-cell lymphomaTCLDiffuse large b-cell lymphomaDLBCLAutologous stem cell transplantationASCTCarfilzomibCFZDexamethasoneDecadron

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD) of Carfilzomib (CFZ) After Autologous Stem Cell Transplantation (ASCT)

    Maximum tolerated dose (MTD) defined as dose with a posterior probability of treatment-related dose-limiting toxicity (DLT) during the first 56 days closest to the target of 30%. DLT defined as: equal or greater than Grade (G) 2 neuropathy with pain, equal or greater than G3 non-hematologic toxicity, G4 neutropenia greater than 7 days, febrile neutropenia, G4 thrombocytopenia lasting for more than 7 days despite withholding CFZ, G3/4 thrombocytopenia with bleeding, or equal or greater than Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal by day 56.

    56 days

Secondary Outcomes (1)

  • Efficacy of Carfilzomib (CFZ) After Autologous Stem Cell Transplantation (ASCT)

    2 years

Study Arms (1)

Carfilzomib

EXPERIMENTAL

Carfilzomib given in four doses, days 1, 2, 15 and 16, every 28 days for 6 months starting within 6 months post ASCT. Doses given in an escalated phase 1 design, starting at 20/20 mg/m2, later increased to 20/27 mg/m2, 20/36 mg/m2 and 20/45 mg/m2. CFZ dose based on actual body surface area at baseline (cycle 1). Patients with a body surface area (BSA) greater than 2.2 m2 receive dose based upon a 2.2 m2 BSA. Adjustments are not made if weight gains or losses are less than or equal to 20% from baseline. Dexamethasone 4 mg by vein or mouth prior to each CFZ dose in cycle 1 and 2 to prevent infusion reactions. After dexamethasone is stopped, then it should be restarted and administered prior to subsequent doses for reactions.

Drug: CarfilzomibDrug: Dexamethasone

Interventions

CarfilzomibDRUG

Starting dose: 20/20 mg/m2 by vein on Days 1, 2, 15, and 16 of each 28 day cycle.

Carfilzomib
DexamethasoneDRUG

4 mg by vein or mouth prior to each Carfilzomib dose in Cycle 1 and 2 to prevent infusion reactions. After dexamethasone is stopped, it should be restarted and administered prior to subsequent doses for reactions.

Also known as: Decadron
Carfilzomib

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with mantle cell lymphoma, T-cell lymphoma, and diffuse large b-cell lymphoma within 6 months post autologous transplantation and without relapse.
  • Age \>/= 18 years to \</= 70 years.
  • Absolute neutrophil count (ANC) \>/= to 1.5 x 10\^9/L; Platelets \> 75 x 10\^9/L.
  • No active infection.
  • Performance status: Eastern Cooperative Oncology Group (ECOG) 2 or less or Karnofsky of at least 60.
  • Cardiac EF \>/= 45% by 2D-Echo.
  • Serum creatinine less than 1.6 mg/dl and Creatinine Clearance \>/= to 30 mL/min.
  • Liver function tests less than 2x upper limit of normal range (unless related to medications or Gilbert's disease).
  • Females of childbearing potential who are not pregnant or breastfeeding.
  • Patient or legally authorized representative able to sign informed consent.

You may not qualify if:

  • Glucocorticoid therapy (prednisone \>30 mg/day or equivalent within 14 days of first dose.
  • POEMS syndrome.
  • Plasma cell leukemia or circulating plasma cells \>/= 2 X 10\^9/L.
  • Waldenstrom's Macroglobulinemia.
  • Patients with known amyloidosis.
  • Immunotherapy or chemotherapy with approved or investigational anticancer therapeutics within 21 days of first dose.
  • Patients previously randomized in any other Onyx-sponsored Phase 3 trial.
  • Active congestive heart failure (NYHA Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 6 months.
  • Acute active infection requiring systemic antibiotics, antiviral (except antiviral directed at Hepatitis B) or antifungal agents within 14 days of first dose.
  • Known HIV seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B SAg or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed).
  • Patients with known cirrhosis.
  • Second malignancy within past three years except: a. adequately treated basal or squamous cell skin cancer. b. carcinoma in situ of the cervix. c. prostate cancer \< Gleason Score 6 with stable prostatic specific antigen (PSA) over the past three months. d. breast cancer in situ with full surgical resection. e. treated medullary or papillary thyroid cancer.
  • Patients with myelodysplastic syndrome.
  • Significant neuropathy (Grades 3 to 4, or Grade 2 pain).
  • Known hypersensitivity to carfilzomib.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

LymphomaLymphoma, Mantle-CellLymphoma, T-CellLymphoma, Large B-Cell, Diffuse

Interventions

carfilzomibDexamethasoneCalcium Dobesilate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-HodgkinLymphoma, B-Cell

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Issa F. Khouri, MD,BS

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2013

First Posted

August 21, 2013

Study Start

June 17, 2014

Primary Completion

September 17, 2017

Study Completion

September 17, 2017

Last Updated

September 19, 2017

Record last verified: 2017-09

Locations

US(1)