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Thiotepa, Busulfan and Fludarabin for pt With Refractory/Early Relapsed Aggressive B-cell Non Hodgkin Lymphomas

NCT01786018 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2014-07-08

No results posted yet for this study

Summary

The purpose of this study is to evaluate progression free survival, transplant-related morbidity (TRM) at day +100 and at +365, overall survival and incidence of acute and chronic GVHD in refractory/early relapsed aggressive B-cell non Hodgkin lymphomas patients treated with allogeneic Transplantation after a conditioning with Thiotepa, Busulfan and fludarabin.

Conditions

  • B-cell Lymphoma Refractory

Interventions

DRUG

Thiotepa

DRUG

Busulfan

DRUG

Fludarabin

PROCEDURE

transplant (HCT)

Transplant will be PBSCs collected as per institutional standard. A portion of the PBSC product will be removed for DLI that is equivalent to 3x10\^7 CD3 cells/kg recipient weight and cryopreserved.

RADIATION

Cytoreduction

Cytoreduction and /or radiation therapy will be given by the referring physician or the attending physician as determined on clinical grounds or to meet eligibility requirements of the protocol for patients with advanced malignancy or to reduce tumor bulk. However, no intensive chemotherapy can be given within three weeks before conditioning.

DRUG

Immunosuppression

Day -3. Commence cyclosporine at 5.0 mg/kg PO Q12 hours, continue to day +50 and then taper by 5% per week until day +180.

DRUG

Cyclosporine

CSP is given based on adjusted body weight, at 5.0 mg/kg PO q12 hours from day -3. If there is nausea and vomiting at anytime during CSP treatment the drug should be given intravenously at the appropriate dose that was used to obtain a therapeutic level. See guidelines for PO to IV conversion below.

DRUG

Methotrexate

Day 1 15 mg Days 3, 6, 11 10 mg m2 day IV for GVHD prevention

DRUG

ATG

(FOR UNRELATED TRANSPLANTS ONLY) Days -3, -2: 2.5 mg /kg/day

PROCEDURE

Collection and infusions of Donor PBSC

Collection and infusions of Donor PBSC

Sponsors & Collaborators

  • Azienda Ospedaliera San Giovanni Battista

    lead OTHER

Principal Investigators

  • Benedetto Bruno, MD · Divisione di Ematologia-Città della Salute e della Scienza di Torino

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01786018 on ClinicalTrials.gov