Lenalidomide Combined With Vorinostat/Gemcitabine/Busulfan/Melphalan With Autologous Stem-Cell Transplantation in Diffuse Large B-Cell Lymphoma of the ABC Subtype

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02589145
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
15 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Lenalidomide — DRUG
    Dose Escalation Phase Starting dose of Lenalidomide: 50 mg by mouth on Days -9 to -2. Dose Expansion Phase Starting Dose: Maximum tolerated dose from Phase I.
  • Vorinostat — DRUG
    1000 mg by mouth on Days -9 to -2.
  • Gemcitabine — DRUG
    Gemcitabine administered as a loading dose of 75 mg/m2 by vein on Day -8 and 2775 mg by vein on Day -3.
  • Busulfan — DRUG
    Busulfan test dose administered by vein either as outpatient before admission, or as inpatient on day -10. The "test dose" of 32 mg/m2 based on actual body weight. Doses of days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1.
  • Melphalan — DRUG
    60 mg/m2 by vein on days -3 and -2.
  • Rituximab — DRUG
    Patients with CD20+ tumors receive Rituximab 375 mg/m2 by vein on day -9 in the AM as an inpatient.
  • Dexamethasone — DRUG
    8 mg by vein twice a day from Day -8 AM to Day -2 PM.
  • Caphosol — DRUG
    Caphosol oral rinses 30 mL four times a day used from Day -8.
  • Glutamine — DRUG
    Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
  • Pyridoxine — DRUG
    100 mg by vein or mouth three times a day from Day -1
  • Enoxaparin — DRUG
    40 mg subcutaneously daily from admission until platelet count drops below 50,000/mm3.
  • Stem Cell Transplant — PROCEDURE
    Stem cell transplant performed on Day 0.
  • Palifermin — DRUG
    Palifermin per departmental standard of care with 3 doses to be administered prior to starting chemotherapy and 3 doses starting on day 0.

Study Details

The goal of this clinical research study is to find the highest tolerable dose of lenalidomide that can be given in combination with vorinostat, gemcitabine, busulfan, and melphalan, with a stem cell transplant, and with or without rituximab. Researchers also want to learn about the safety and effectiveness of this combination.

Key Dates

Start date
Jun 22, 2016
Status verified
Nov 2019
Primary completion
Apr 8, 2019
Completion
Apr 8, 2019

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lenalidomide + Vorinostat/Gem/Bu/Mel + AutoSCT
    Vorinostat and lenalidomide administered orally at the same time within 1 hour before the daily dose of chemotherapy. Gemcitabine administered as a loading dose of 75 mg/m2 followed by infusion on days -8 and -3. Busulfan test dose administered as outpatient before admission, or as inpatient on day -10. The "test dose" of 32 mg/m2 based on actual body weight. Doses of days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Melphalan administered at 60 mg/m2 on days -3 and -2. Patients with CD20+ tumors receive rituximab 375 mg/m2 on day -9 in the AM as an inpatient. Dexamethasone 8 mg by vein twice a day from day -8 to day -2. Caphosol oral rinses 30 mL four times a day used from day -8. Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on day -8. Pyridoxine 100 mg by vein or mouth three times a day from day -1. Enoxaparin 40 mg subcutaneously daily from admission until platelet count drops below 50,000/mm3.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: Enrollment up to day 30 post transplant for each dosing cohort ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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